Introduction

Synthetic bisphosphonate; bone resorption inhibitor.

Uses for Ibandronate

Osteoporosis

Prevention of osteoporosis in postmenopausal women. Risk factors for postmenopausal osteoporosis and related fractures include early menopause, advanced age, low bone mineral density (BMD), low body mass index (BMI), previous fracture or family history of fracture/osteoporosis, excessive alcohol intake, smoking, inadequate physical activity, low calcium and vitamin D intake, certain drugs (e.g., glucocorticoids), and medical conditions or diseases (e.g., rheumatoid arthritis, diabetes mellitus, Cushing syndrome, hyperparathyroidism).

Treatment of osteoporosis in postmenopausal women.

In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with previous hip or vertebral fractures or low BMD; pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients.

Use of a drug with proven efficacy in reducing fracture risk is recommended; bisphosphonates (e.g., alendronate, risedronate, zoledronic acid, ibandronate) are recommended as one of several first-line drugs.

Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors.

Glucocorticoid-induced Osteoporosis

Also has been used in the management of glucocorticoid-induced osteoporosis^{† [off-label]}.

American College of Rheumatology (ACR) recommends optimizing calcium and vitamin D intake and lifestyle modifications (e.g., diet, smoking cessation, weight-bearing or resistance-training exercise) in all patients receiving long-term glucocorticoid therapy; in addition, pharmacologic therapy with an oral bisphosphonate is recommended in patients who are considered to be at moderate-to-high risk of fracture. Oral bisphosphonates generally are preferred because of their demonstrated antifracture benefits, safety, and low cost.

Ibandronate Dosage and Administration

General

• Correct hypocalcemia and other disturbances of bone and mineral metabolism prior to initiation of therapy.
• Provide supplemental calcium and vitamin D if dietary intake is inadequate.

Administration

Oral Administration

Administer orally with a full glass (180–240 mL) of plain water ≥60 minutes prior to the first food, beverage (other than plain water), or other orally administered drug or supplement (including vitamins, antacids, and calcium) of the day. (See Food under Pharmacokinetics.)

Avoid lying down for ≥60 minutes following administration.

Do not to suck or chew tablets; potential for oropharyngeal ulceration. (See Upper GI Effects under Cautions.)

If a morning daily oral dose is missed, do not take missed dose later that same day. Resume the regular schedule the next day.

When administered monthly, take tablets in the morning on the same day each month. If a monthly dose is missed and the next scheduled dose is more than 7 days away, take the missed dose the next morning after it is remembered and resume the regular schedule. If the next scheduled dose is 1–7 days away, maintain the regular schedule; do not take more than one 150-mg tablet within the same week.

IV Administration

Administer by IV injection once every 3 months by a health-care professional.

Injection must only be administered IV. Safety and efficacy of IV injection administered by other routes not established.

Because of the risk of anaphylaxis or other severe hypersensitivity reactions, appropriate medical support should be readily available during IV administration. (See Hypersensitivity under Cautions.)

If a dose is missed, reschedule administration with a health-care professional as soon as possible. Schedule subsequent injections at 3-month intervals; should not be administered more often than once every 3 months.

Administration Risks

Take care to avoid intra-arterial or paravenous injection as such administration could result in tissue damage.

Rate of Administration

Administer IV over a period of 15–30 seconds.

Dosage

Available as ibandronate sodium (as the monosodium monohydrate); dosage expressed in terms of ibandronate.

Adults

Osteoporosis

Prevention in Postmenopausal Women

Oral

150 mg once monthly.

Osteoporosis

Treatment in Postmenopausal Women

Oral

150 mg once monthly.

Optimal duration of treatment not established. Safety and efficacy based on data over 3 years. Reevaluate need for continued therapy periodically in all patients receiving bisphosphonates. Consider discontinuance of bisphosphonate therapy after 3–5 years in patients at low risk of fracture. Evaluate fracture risk periodically in patients who discontinue therapy.

IV

3 mg once every 3 months.

Optimal duration of treatment not established. Safety and efficacy of IV ibandronate based on data supporting fracture reduction over 1 year of treatment. Reevaluate need for continued therapy periodically in all patients receiving bisphosphonates. Consider discontinuance of bisphosphonate therapy after 3–5 years in patients at low risk of fracture. Evaluate fracture risk periodically in patients who discontinue therapy.

Special Populations

Renal Impairment

Oral or IV

Dosage adjustments not necessary in patients with mild to moderate renal impairment (Cl_cr ≥30 mL/minute); use not recommended in patients with severe renal impairment (Cl_cr <30 mL/minute).

Cautions for Ibandronate

Contraindications

• Oral: Esophageal abnormalities that delay esophageal emptying (e.g., stricture, achalasia).
• Oral and IV: Uncorrected hypocalcemia.Oral and IV: Known hypersensitivity to ibandronate or any ingredient in the formulation.
• Oral: Inability to stand or sit upright for ≥60 minutes.

Warnings/Precautions

Upper GI Effects

Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation). (See Oral Administration under Dosage and Administration.) Monitor for any manifestations and discontinue if dysphagia, odynophagia, new or worsening heartburn, or retrosternal pain occurs.

Use with caution in patients with active upper GI disease (e.g., Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers). Gastric and duodenal ulcers (some severe and with complications) reported during postmarketing experience.

Route of Administration

Injection must be administered IV by a health-care professional; do not administer by non-IV (e.g., intra-arterial) routes. (See Administration Risks under Dosage and Administration.)

Metabolic Effects

Correct hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before initiating therapy.

If daily intake inadequate, administer supplemental calcium and vitamin D.

Osteonecrosis of the Jaw

Osteonecrosis and osteomyelitis of the jaw reported in patients receiving bisphosphonates. Most cases associated with tooth extraction and/or local infection with delayed healing. Known risk factors include cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and comorbid disorders (e.g., periodontal and/or other preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Risk also may be increased with increased duration of bisphosphonate use.

If osteonecrosis of the jaw develops, consult an oral surgeon for treatment. Dental surgery may exacerbate condition.

In patients requiring dental procedures, discontinuance of therapy prior to procedure may reduce the risk of osteonecrosis of the jaw. Base management of patients requiring dental treatment on an individual assessment of risks and benefits.

Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain reported infrequently with bisphosphonate therapy. Time to onset varied from 1 day to years (mean onset about 3 months) after treatment initiation. If severe symptoms occur, consider discontinuing drug. Such pain generally improves following discontinuance, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.

Atypical Fracture of the Femur

Atypical (subtrochanteric or diaphyseal) femur fractures reported rarely with long-term use (>3 years) of bisphosphonates, mostly in patients receiving these drugs for osteoporosis. Often occurs with minimal or no trauma, and may be bilateral. Causality not established; atypical fractures also occur in osteoporotic patients not receiving bisphosphonates. Risk may be increased with concomitant use of glucocorticoid, estrogen, and proton-pump inhibitor therapy.

Evaluate patients who present with new thigh or groin pain for possibility of an atypical femoral fracture; include assessment of the contralateral limb. Consider interruption of bisphosphonate therapy in patients with manifestations of possible femoral fracture; weigh risks versus benefits of continued treatment. Discontinue if a femoral shaft fracture is confirmed.

Atrial Fibrillation

Although data are conflicting, possible increased risk of atrial fibrillation with use of bisphosphonates. FDA analysis of data from long-term (6 months to 3 years) controlled trials identified a higher rate of atrial fibrillation in patients receiving bisphosphonates (alendronate, ibandronate, risedronate, or zoledronic acid) versus placebo; however, only a few events reported in each study. FDA is continuing to monitor this safety concern.

Potential Risk of Esophageal Cancer

Some evidence (from postmarketing experience and observational studies) suggests a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer. However, because of conflicting data, additional study needed to confirm such findings.

FDA states that benefits of oral bisphosphonates continue to outweigh their potential risks in patients with osteoporosis; it is important to consider that esophageal cancer is rare, especially in women.

Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function and, rarely, renal failure) with bisphosphonates. Risk may be greater in patients with coexisting conditions associated with renal impairment, concomitant therapy with other nephrotoxic drugs, preexisting renal disease, dehydration, dosage, infusion volume and rate, and multiple cycles of treatment. Assess renal function in such patients.

Use not recommended in patients with severe renal impairment (Cl_cr <30 mL/minute).

Measure S_cr prior to each IV dose. Withhold treatment if deterioration of renal function occurs.

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions, including fatal anaphylaxis in patients who received ibandronate injection, reported. (See Contraindications under Cautions and see IV Administration under Dosage and Administration.)

Specific Populations

Pregnancy

No data in pregnant women to inform any drug-associated risks. In reproductive animal studies, maternal and fetal toxicity (including postimplantation loss, developmental anomalies, and deaths) observed.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Also not known whether the drug has any effects on the nursing infant or milk production.

Pediatric Use

Safety and efficacy not established in children. Not indicated for use in children.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. Consider age-related decreases in renal function.

Renal Impairment

Use not recommended in patients with severe renal impairment (CL_cr <30 mL/minute).

Common Adverse Effects

Oral: Back pain, dyspepsia, pain in the extremities, diarrhea, headache, myalgia.

IV: Arthralgia, back pain, abdominal pain.

Drug Interactions

Does not induce or inhibit CYP isoenzymes (i.e., CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, or 3A4) and is not metabolized.

Antacids or Mineral Supplements Containing Divalent Cations

Pharmacokinetic interaction (decreased absorption of ibandronate) when tablets are used concomitantly with antacids or mineral supplements containing divalent cations (e.g., aluminum, calcium, magnesium, iron). Administer tablets ≥60 minutes prior to such drugs or supplements.

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely.

Drugs Excreted through Renal Tubular Transport

Based on limited data in animals, not excreted through renal tubular transport. Pharmacokinetic interaction unlikely.

Nephrotoxic Agents

Potential pharmacologic interaction (increased risk of renal toxicity). Assess patients taking concomitant nephrotoxic agents. (See Renal Effects under Cautions.)

Specific Drugs and Tests

Ibandronate Pharmacokinetics

Absorption

Bioavailability

Absolute (compared with IV administration) oral bioavailability about 0.6%.

Onset

Reduction in bone turnover evident within 1–3 months of treatment initiation; maximal effects observed at 6 months.

Food

Bioavailability decreased by 90% when administered with a standard breakfast compared with administration under fasting conditions. Bioavailability and effect on BMD reduced when food and beverages taken <60 minutes following oral administration.

Special Populations

In patients with renal impairment (Cl_cr 40–70 mL/minute), AUC is increased by 55% compared with that in patients with normal renal function (Cl_cr >90 mL/minute). Patients with severe renal impairment (Cl_cr <30 mL/minute) had >2-fold increase in AUC compared with exposure for healthy individuals.

Distribution

Extent

Widely distributed throughout the body and redistributed to bone. Subsequently, the drug is released systemically via bone turnover. Not known whether distributed into milk.

Plasma Protein Binding

84–99.5% at therapeutic drug concentrations.

Elimination

Metabolism

No evidence of metabolism.

Elimination Route

Excreted in urine (50–60% of circulating dose) as unchanged drug and in feces (unabsorbed drug).

Half-life

Apparent oral terminal half-life is 37–157 hours; dose-dependent.

Apparent IV terminal half-life is 4.6–25.5 hours; dose-dependent.

Special Populations

Pharmacokinetic differences based on race not evaluated. Pharmacokinetics not affected by gender.

Pharmacokinetics not evaluated in pediatric patients. Pharmacokinetics in patients with hepatic impairment not studied as ibandronate is not metabolized in the liver.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).

Parenteral

Injection

25°C (may be exposed to 15–30°C).

Compatibility

Parenteral

Do not admix with calcium-containing solutions or other IV drugs.

Actions

• Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption in a dose-dependent manner.
• Reduces biochemical markers of bone resorption in patients with postmenopausal osteoporosis.
• Maintains or increases BMD and increases bone mass in postmenopausal women.

Advice to Patients

• Importance of providing patient with a copy of the manufacturer’s patient information.
• Importance of adhering to recommended life-style modifications (e.g., exercise, calcium and vitamin D supplementation).
• Importance of correct oral administration (e.g., avoiding foods and beverages other than plain water [including mineral water] prior to administration, not lying down for ≥60 minutes following administration).
• Importance of not taking vitamins, calcium, or antacids ≤60 minutes of taking oral ibandronate.
• Necessity of swallowing tablets whole, without chewing or sucking.
• Importance of reviewing how to resume therapy in the event of a missed dose.
• Importance of discontinuing oral ibandronate and informing clinician if symptoms of esophageal disease (e.g., new or worsening dysphagia, difficulty or pain on swallowing, retrosternal pain, heartburn) develop.
• Importance of informing a clinician if severe bone pain, joint pain, muscular pain, or jaw problems develop.
• Importance of women informing clinicians if they are or plan to become pregnant or to plan to breast-feed.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (vitamins, supplements, antacids), as well as any concomitant illnesses (e.g., preexisting dysphagia, esophageal disorders, renal impairment).
• Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

What is Ibrance?

Ibrance is used to treat HR-positive, HER2-negative breast cancer that has spread to other parts of the body. Ibrance is used in combination with an aromatase inhibitor as the first hormonal-based therapy, or fulvestrant in those with breast cancer progression following hormonal therapy.

Ibrance’s mechanism of action involves blocking proteins involved in cell division called cyclin-dependent kinases (CDK), specifically CDK 4 and 6, preventing the cancer from dividing and multiplying uncontrollably. HR+ breast cancer cells rely heavily on CDK 4/6 for growth. Ibrance belongs to the drug class CDK 4/6 inhibitors.

Ibrance is a targeted treatment, it is not chemotherapy .

Ibrance gained FDA approval on February 3, 2015. An Ibrance generic is available under the name palbociclib .

Ibrance uses

Ibrance is used to treat HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women or men. Ibrance should always be used in combination with:

• an aromatase inhibitor (such as anastrozole, exemestane, or letrozole) as initial endocrine-based therapy in postmenopausal women or men; or
• fulvestrant in patients with disease progression following endocrine therapy.

Ibrance side effects

The most common side effects of Ibrance are:

• infections
• tiredness
• nausea
• sore mouth
• abnormalities in liver blood tests
• diarrhea
• hair thinning or hair loss
• vomiting
• rash
• loss of appetite
• low red blood cell counts and low platelet counts. Call your healthcare provider right away if you develop any of these symptoms of low blood cell  during treatment dizziness, shortness of breath, weakness, bleeding or bruising more easily, or nosebleeds

These Ibrance side effects are the most common ones that occur when used with either letrozole or fulvestrant.

Hair loss is not considered a common side effect of Ibrance. Ibrance is more likely to cause hair thinning .

Ibrance may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting Ibrance if this is a concern for you.

Serious side effects and warnings

Ibrance may cause the following serious side effects.

Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking Ibrance and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment.

If you develop low white blood cell counts during treatment with Ibrance, your healthcare provider may stop your treatment, decrease your dose, or tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

Lung problems (pneumonitis). Ibrance may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

• chest pain
• cough with or without mucus
• trouble breathing or shortness of breath.

Your healthcare provider may interrupt or stop treatment with Ibrance completely if your symptoms are severe.

It is not known if Ibrance is safe and effective in children.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Ibrance. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking

Before taking Ibrance, tell your healthcare provider about all of your medical conditions, including if you:

• have a fever, chills, or any other signs or symptoms of infection
• have liver or kidney problems
• have any other medical conditions
• are pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Ibrance can harm your unborn baby. Females who can become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of Ibrance. Your healthcare provider may ask you to take a pregnancy test before you start treatment with Ibrance.

Males with female partners who can become pregnant should use effective birth control during treatment with Ibrance for at least 3 months after the last dose of Ibrance. Talk to your healthcare provider about birth control methods that may be right for you during this time.

If you become pregnant or think you are pregnant, tell your healthcare provider right away.

Breastfeeding

It is not known if Ibrance passes into your breast milk. Do not breastfeed during treatment with Ibrance and for 3 weeks after the last dose.

How should I take Ibrance?

Take Ibrance exactly as your healthcare provider tells you.

• Take Ibrance with or without food.
• Ibrance should be taken at about the same time each day.
• Swallow Ibrance capsules or tablets whole. Do not chew or crush the capsules or tablets and do not try to open the capsules before swallowing them.
• Do not take any Ibrance capsules or tablets that are broken, cracked, or that look damaged.

Avoid grapefruit and grapefruit products during treatment with Ibrance. Grapefruit may increase the amount of Ibrance in your blood.

Do not change your dose or stop taking Ibrance unless your healthcare provider tells you.

Ibrance dosage

The recommended initial Ibrance dosage for breast cancer is Ibrance 125 mg 1 time daily with or without food for 21 days followed by 7 days without treatment.

• Your healthcare provider may adjust your dose based on how well you tolerate Ibrance.
• Ibrance is taken in combination with an aromatase inhibitor or fulvestrant.  

What happens if I miss a dose?

If you miss a dose of Ibrance or vomit after taking a dose of Ibrance, do not take another dose on that day. Take your next dose at your regular time.

What happens if I take too much Ibrance?

If you take too much Ibrance, call your healthcare provider right away or go to the nearest hospital emergency room.

What other drugs will affect Ibrance?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ibrance and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

• CYP3A Inhibitors, such as clarithromycin, diltiazem, erythromycin, fluconazole, ketoconazole, or verapamil. These should not be taken at the same time as Ibrance. If a strong CYP3A inhibitor cannot be avoided, your healthcare provider should reduce the dose of Ibrance
• CYP3A Inducers, such as glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid using these at the same time as Ibrance
• CYP3A substrates, such as cyclosporin, tricyclic antidepressants, and some chemotherapy agents. The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with Ibrance.

Avoid grapefruit and grapefruit products.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. This is not a full list of interactions with Ibrance.

Generic name: ibuprofen [ EYE-bue-PROE-fen ]
Brand names: Advil, Advil Migraine, Children’s Advil, Children’s Ibuprofen Berry
Drug class: Nonsteroidal anti-inflammatory drugs 

What is Ibu?

Ibu is a nonsteroidal anti-inflammatory drug (NSAID).

Ibu is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury. Ibu is used in adults and children who are at least 6 months old.

Ibu may also be used for purposes not listed in this medication guide.

Ibu side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Ibu may cause serious side effects. Stop using Ibu and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)–pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of Ibu may include:

• nausea, vomiting, gas;
• bleeding; or
• dizziness, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Ibu can increase your risk of fatal heart attack or stroke. Do not use Ibu just before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Ibu can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibu may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Ibu if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• liver or kidney disease;
• asthma; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you are pregnant, you should not take Ibu unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Do not give Ibu to a child younger than 6 months old without the advice of a doctor.

How should I take Ibu?

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

An Ibu overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child’s dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with children’s Ibu for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take Ibu with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since Ibu is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Ibu?

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Ibu (such as aspirin, this medicine, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking Ibu can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take this medicine at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

What other drugs will affect Ibu?

Ask your doctor before using Ibu if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using Ibu with any other medications, especially:

• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).

What is ibuprofen?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

Ibuprofen is used in adults and children who are at least 6 months old.

Warnings

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.

Before taking this medicine

You should not use ibuprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• liver or kidney disease;
• asthma; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you are pregnant, you should not take ibuprofen unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Do not give ibuprofen to a child younger than 6 months old without the advice of a doctor.

How should I take ibuprofen?

Use ibuprofen exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child’s dose is based on the age and weight of the child. Carefully follow the dosing instructions provided with children’s ibuprofen for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take ibuprofen with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since ibuprofen is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What to avoid

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take ibuprofen at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ibuprofen side effects

Get emergency medical help if you have signs of an allergic reaction to ibuprofen (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common ibuprofen side effects may include:

• nausea, vomiting, gas;
• bleeding; or
• dizziness, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect ibuprofen?

Ask your doctor before using ibuprofen if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using ibuprofen with any other medications, especially:

• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).

What is Iclusig?

Iclusig is an oral kinase inhibitor that may be used to treat adults with:

• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in those who cannot receive any other kinase inhibitor medicines or have a specific type of abnormal gene (T315I-positive Ph+ ALL)
• Newly diagnosed Ph+ ALL in combination with chemotherapy (this approval is under the accelerated approval designation and is based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction)
• Chronic phase chronic myeloid leukemia (CML) who did not tolerate or no longer benefit from treatment with at least 2 prior kinase inhibitor medicines
• T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Iclusig is not for use to treat people with newly diagnosed chronic phase CML.

It is not known if Iclusig is safe and effective in children.

Warnings

Iclusig may cause heart or blood vessel problems that could lead to heart attack, stroke, or death.

Call your doctor or get emergency medical help if you have: chest pain spreading to your jaw or shoulder, shortness of breath, dizziness, severe stomach pain, swelling in your legs, sudden numbness or weakness, headache, or problems with vision or speech.

Iclusig may also harm your liver. Call your doctor right away if you have upper stomach pain with loss of appetite, dark urine, bruising, or yellowing of your skin or eyes.

Before taking this medicine

You should not use Iclusig if you are allergic to ponatinib.

To make sure Iclusig is safe for you, tell your doctor if you have ever had:

• heart failure, high blood pressure, heart rhythm problems;
• long QT syndrome (in you or a family member);
• a stroke or blood clot;
• diabetes;
• high cholesterol;
• liver disease;
• bleeding problems;
• lactose intolerance (tablets may contain lactose);
• pancreatitis; or
• if you’ve had surgery within the past 2 weeks.

You may need to have a negative pregnancy test before starting this treatment.

Ponatinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because Iclusig can harm an unborn baby.

You should not breastfeed while using Iclusig and for at least 6 days after your last dose.

How should I take Iclusig?

Take Iclusig exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Iclusig is usually taken once daily, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using Iclusig. You may need to stop using the medicine at least 1 week before surgery.

Do not stop taking Iclusig or change your medication dose without your doctor’s advice.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Chronic Myelogenous Leukemia:

Chronic phase chronic myeloid leukemia (CP-CML):
-Initial Dose: 45 mg orally once a day
-Upon achievement of 1% BCR-ABL1 or less (standardized according to International Scale): 15 mg orally once a day
-For loss of response: Re-escalate to a previously tolerated dosage of 30 mg or 45 mg orally once a day

Accelerated phase chronic myeloid leukemia (AP-CML), blast phase chronic myeloid leukemia (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL):
-Initial dose: 45 mg orally once a day

Comments:
-The optimal dose has not been identified for AP-CML, BP-CML, and Ph+ ALL.
-Consider dose reduction for AP-CML patients who have achieved major cytogenic response.
-Continue treatment until loss of response or unacceptable toxicity.
-Drug discontinuation should be considered if patient response has not occurred by 3 months (90 days).
-This drug is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML).

Uses:
-For the treatment of adult patients with CP-CML with resistance or intolerance to at least two prior kinase inhibitors
-For the treatment of adult patients with AP-CML, or BP-CML or Ph+ ALL for whom no other kinase inhibitors are indicated
-For the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL

Usual Adult Dose for Acute Lymphoblastic Leukemia:

Chronic phase chronic myeloid leukemia (CP-CML):
-Initial Dose: 45 mg orally once a day
-Upon achievement of 1% BCR-ABL1 or less (standardized according to International Scale): 15 mg orally once a day
-For loss of response: Re-escalate to a previously tolerated dosage of 30 mg or 45 mg orally once a day

Accelerated phase chronic myeloid leukemia (AP-CML), blast phase chronic myeloid leukemia (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL):
-Initial dose: 45 mg orally once a day

Comments:
-The optimal dose has not been identified for AP-CML, BP-CML, and Ph+ ALL.
-Consider dose reduction for AP-CML patients who have achieved major cytogenic response.
-Continue treatment until loss of response or unacceptable toxicity.
-Drug discontinuation should be considered if patient response has not occurred by 3 months (90 days).
-This drug is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML).

Uses:
-For the treatment of adult patients with CP-CML with resistance or intolerance to at least two prior kinase inhibitors
-For the treatment of adult patients with AP-CML, or BP-CML or Ph+ ALL for whom no other kinase inhibitors are indicated
-For the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Grapefruit may interact with ponatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Iclusig side effects

Get emergency medical help if you have signs of an allergic reaction to Iclusig: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Iclusig may cause heart or blood vessel problems that could lead to heart attack or stroke. Call your doctor right away or get emergency medical help if you have:

• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, feeling short of breath;
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
• signs of a blood clot – severe stomach pain, pain or swelling in your arms or legs, coughing up blood.

Call your doctor at once if you have:

• dizziness, confusion, headache, change in mental status;
• a seizure;
• swelling, rapid weight gain, feeling short of breath;
• a wound that will not heal;
• eye problems – vision problems, eye pain or swelling, bleeding in the eye, increased sensitivity to light, flashes of light or “floaters” in your vision;
• heart problems – chest pain, shortness of breath, fast or pounding heartbeats, feeling like you might pass out;
• a hole or tear in your stomach or intestine – severe pain or swelling in your stomach with a high fever;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet;
• nerve problems – muscle weakness, trouble moving your eyes or other parts of your face, tingling, burning pain, numbness in your hands and feet;
• severe bleeding – nosebleeds, bloody or tarry stools, pink or brown urine, heavy menstrual periods, coughing up blood or vomit that is bloody or looks like coffee grounds; or
• signs of liver or pancreas problems – loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Common Iclusig side effects include:

• dry skin, rash;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• headache, muscle or joint pain;
• pain in your arms, hands, legs, or feet;
• increased blood pressure; or
• fever, tired feeling.

What is icosapent?

Icosapent is used together with other medicines (such as statins) to reduce the risk of heart attack, stroke, and some types of heart problems that need hospitalization in adults.

Icosapent is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides.

It is not known whether icosapent will lower your risk of pancreatitis (inflammation of your pancreas).

Icosapent may also be used for purposes not listed in this medication guide.

Icosapent side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Icosapent may cause serious side effects. Call your doctor at once if you have:

• fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or
• serious bleeding.

Common side effects of icosapent may include:

• muscle or joint pain;
• constipation;
• swelling of the hands, legs, or feet.
• gout; or
• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use icosapent if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease;
• diabetes;
• a thyroid disorder;
• problems with your pancreas;
• a bleeding or blood-clotting disorder; or
• if you are allergic to fish or shellfish.

It is not known whether icosapent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Icosapent can pass into breast milk, and may harm your baby. Tell your doctor if you are breastfeeding.

Icosapent is not approved for use by anyone younger than 18 years old.

How should I take icosapent?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You will need frequent blood tests.

Icosapent is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Icosapent dosing information

Usual Adult Dose for Hypertriglyceridemia:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

Usual Adult Dose for Cardiovascular Risk Reduction:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking icosapent?

Avoid eating foods that are high in fat or cholesterol. Icosapent will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

What other drugs will affect icosapent?

Tell your doctor about all your other medicines, especially:

• a blood thinner–warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect icosapent, including prescription and over-the-counter medicines, vitamins, and herbal products. 

What is Idhifa?

Idhifa targets a specific gene mutation called IDH2, which can affect your bone marrow. IDH2 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia.

Idhifa is used to treat acute myeloid leukemia in adults with an IDH2 mutation.

Idhifa is used when AML has come back or has not improved with prior treatment.

Warnings

Idhifa can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking this medicine.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

Before taking this medicine

You should not use Idhifa if you are allergic to enasidenib.

Before using Idhifa tell your doctor about all your medical conditions or allergies.

You may need to have a negative pregnancy test before starting this treatment. In animal studies, enasidenib caused miscarriage, low birth weight, stillbirth, and birth defects.

Enasidenib may harm an unborn baby. Use a barrier form of birth control (condom or diaphragm with spermicide) to prevent pregnancy while you are using Idhifa. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

You should use birth control to prevent pregnancy while using this medicine whether you are a man or a woman. Idhifa use by either parent may cause birth defects.

Keep using birth control for at least 2 months after your last dose of Idhifa. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

Idhifa may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because enasidenib may harm the baby if a pregnancy does occur.

It is not known whether enasidenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 1 month after your last dose.

How should I take Idhifa?

Take Idhifa exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Idhifa exactly as prescribed by your doctor. Idhifa is usually given once per day. Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking this medicine.

You may take this medicine with or without food.

Do not crush, chew, or break a tablet. Swallow the tablet whole.

Idhifa is usually given until your body no longer responds to the medication.

If you vomit shortly after taking Idhifa, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the canister of moisture-absorbing preservative.

Dosing information

Usual Adult Dose for Acute Myeloid Leukemia:

100 mg orally once a day with or without food

Duration of Therapy:
-Treat until disease progression or unacceptable toxicity.
-For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Comments: Select patients based on the presence of isocitrate dehydrogenase-2 (IDH2) mutations in the blood or bone marrow as detected by an FDA-approved test, http://www.fda.gov/CompanionDiagnostics.

Use: Treatment of relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Idhifa side effects

Get emergency medical help if you have signs of an allergic reaction to Idhifa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Idhifa can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking Idhifa.

Seek medical help right away if you have symptoms of differentiation syndrome:

• fever, cough, trouble breathing;
• bone pain;
• rapid weight gain; or
• swelling in your arms, legs, underarms, groin, or neck.

Call your doctor at once if you have any of these side effects:

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe or ongoing vomiting or diarrhea; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common Idhifa side effects may include:

• nausea, vomiting, diarrhea;
• loss of appetite; or
• jaundice.

What is Ilumya? 

Ilumya injection is used for moderate-to-severe plaque psoriasis to help reduce plaques, scales, and redness, making the skin clearer and less itchy. Ilumya works to balance the overactive immune system by blocking the IL-23 protein involved in inflammatory and immune responses. Ilumya active ingredient is tildrakizumab asmn.

Ilumya mechanism of action is it selectively binds to the p19 subunit of interleukin-23  (IL-23) and blocks its interaction with the IL-23 receptor. This decreases the release of proteins  (cytokines and chemokine) that cause inflammation, which improves plaque psoriasis symptoms. Ilumya injection is a humanized IgG1/k monoclonal antibody.

Ilumya is given as an injection under the skin (subcutaneous) monthly and then every 12 weeks as a maintenance dose.

Who can use Ilumya?

Ilumya FDA approval is for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya FDA approval was granted on March 21, 2018, after positive results from clinical trials reSURFACE 1 study.  In the study, 74 percent (229 patients) using Ilumya (tildrakizumab-asmn) achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100 mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo.

Ilumya side effects

Common Ilumya side effects

Common Ilumya side effects may include:

• including pain, itching, rash, redness, swelling, bruising, or bleeding where the medicine was injected injections site reactions)
• diarrhea; or
• cold symptoms including stuffy nose, sneezing, sore throat (upper respiratory infections).

 Serious Ilumya side effects

Get emergency medical help if you have signs of an allergic reaction to Ilumya: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection, such as:

• fever, chills, sweating;
• skin sores;
• muscle pain;
• increased urination, pain or burning when you urinate;
• stomach pain, diarrhea, weight loss; or
• cough, shortness of breath, coughing up pink or red mucus.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Infections Ilumya affects your immune system, and you may get infections more easily. Call your doctor if you have signs or symptoms of clinically important chronic or acute infection, including fever, chills, aches, cough, shortness of breath, skin sores, diarrhea, weight loss, or burning when you urinate. If a serious infection develops, your doctor may consider discontinuing Ilumya until the infection has cleared.

Tuberculosis (TB). Before starting Ilumya treatment, your healthcare provider will test you for tuberculosis (TB). If you have active TB or a history of it, you will receive treatment for TB first. You will also be monitored for any signs and symptoms of TB. 

Serious allergic reactions: Get emergency medical help right away if you get any symptoms of serious allergic reactions, including feeling faint, skin rash, swelling of your face, eyelids, lips, trouble breathing or throat tightness, mouth, tongue or throat, chest tightness.

 Immunizations: Avoid the use of live vaccines.

Before receiving this medicine

You should not be treated with Ilumya if you are allergic to the active ingredient tildrakizumab or any inactive ingredients. There is a full list of ingredients at the bottom of this page.

Tell your doctor if you have a chronic infection or are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis.

It is not known whether Ilumya will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How is Ilumya given?

Ilumya is given as an injection under your skin (subcutaneous injection) in areas of your body such as your thighs, stomach area (abdomen), or upper arm.

A healthcare provider will administer your Ilumya injection.

Before you start treatment with Ilumya, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Ilumya Dosing information

Usual Adult Ilumya Dose for Plaque Psoriasis:

• 100 mg subcutaneously at Weeks 0 and 4 and every 12 weeks after that.

General dosing information

Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.

• Ilumya should only be administered by a healthcare provider.
• Before injection, remove the carton from the refrigerator and let the prefilled syringe (in the carton with the lid closed) sit at room temperature for 30 minutes.
• Follow the instructions on the carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.
• Inspect the syringe visually for particulate matter and discoloration before administration. The product is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.
• Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Do not inject into scars, stretch marks, or blood vessels.
• While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  Inject the full amount (1 mL), which provides 100 mg of drug per syringe.
• Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
• Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safely lock will draw the needle inside the needle guard.
• If a dose is missed, administer the dose as soon as possible; thereafter, resume dosing at the regularly scheduled interval.

Ilumya J code

Ilumya J code is J3245 (1 mg, injection)
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important, accurate, and consistent coding for billing and reimbursement purposes.

Your physician will need an Ilumya J-code when filling out forms for your treatment.

Ilumya Support and savings

Ilumya Support is a program to help patients with personalized email and text message support when treated with Ilumya for moderate-to-severe plaque psoriasis. Ilumya Support will also help with financial support if you are eligible.

Ilumya Enrolment form and Ilumya copay card

To access the support program, you will need to fill out the Ilumya enrolment form which is available on the Ilumya prices and coupon page.

With the Ilumya Copay card, you may pay as little as $0 for Ilumya if you have commercial insurance that provides coverage for this medicine and are a resident of the United States, Puerto Rico, Guam, or the Virgin Islands. This coverage is for out-of-pocket costs, which may include Copay, co-insurance, or deductible. 

You are not eligible for the copay program is you are enrolled in any state or federally-funded insurance program, including, but not limited to, Medicare, Medicaid, TRICARE, Veterans Affairs Health Care, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other state or federal assistance program. Check the terms and conditions for the copay program at Ilumya Support.

What happens if I miss a dose?

If you miss a follow-up appointment and do not receive your dose, schedule another appointment as soon as possible.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Ilumya?

Do not receive a “live” vaccine while using Ilumya. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Ilumya?

Other drugs may interact with tildrakizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Does Ilumya interact with my other drugs?

Enter medications to view a detailed interaction report using  Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Ilumya Package Insert 

Review the Ilumya Package Insert  (Ilumya PI) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called  Ilumya Prescribing Information or  Ilumya FDA label.

Storage 

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. 
• It can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard ILUMYA. Do not store ILUMYA above 25°C (77°F).
• Do not freeze. 
• Do not shake.

Ingredients

Active ingredient: tildrakizumab-asmn

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Company

Ilumya Sun Pharmaceutical Industries Limited

Manufactured by Sun Pharmaceutical Industries Limited Mumbai, Maharashtra India 400 063

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Tildrakizumab-asmn (active ingredient) is a Product of South Korea.

What is imatinib?

Imatinib (brand names Gleevec [oral tablet], Imkeldi [oral solution]) is used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer.

Imatinib is also used to treat certain tumors of the stomach and digestive system.

Imatinib’s mechanism of action involves targeting BCR-ABL tyrosine kinase and some other kinases, particularly ones responsible for uncontrolled cell growth. By preventing these enzymes from working properly, imatinib slows cancer growth and spread. Imatinib belongs to the drug class called BCR-ABL tyrosine kinase inhibitors.

Imatinib gained FDA approval on May 10, 2001, under the brand name Gleevec. A generic Gleevec is available known as imatinib mesylate. Imatinib is also available under the brand name Imkeldi which is an oral solution. There is no Imkeldi generic.

Warnings

Imatinib can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Imatinib may increase the risk of liver problems. Tell your doctor if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Imatinib may increase the risk of fluid retention or heart problems. Tell your doctor if you have swelling or rapid weight gain, shortness of breath, fast or slow heart rate, weak pulse, or fainting.

Before taking this medicine

You should not use imatinib if you are allergic to it.

To make sure imatinib is safe for you, tell your doctor if you have ever had:

• liver disease (especially hepatitis B);
• kidney disease;
• underactive thyroid, recent or upcoming thyroid surgery;
• heart disease, high blood pressure, congestive heart failure;
• a stomach ulcer or bleeding;
• diabetes; or
• chemotherapy.

You may need to have a negative pregnancy test before starting this treatment.

Do not use imatinib if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using imatinib and for at least 14 days after your last dose.

Do not breastfeed a baby while you are using this medicine and for at least 1 month after your last dose.

How should I take imatinib?

Take imatinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Imatinib tablets

Take imatinib with a meal and a large glass of water. Do not take imatinib on an empty stomach.

If you cannot swallow a tablet whole, you may dissolve it in a glass of water or apple juice to make the pill easier to swallow. Use about 2 ounces of liquid for each 100-milligram tablet, or 7 ounces of liquid for each 400-milligram tablet. Stir the mixture and drink all of it right away.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a broken pill.

Imatinib oral solution (Imkeldi)

You must measure Imkeldi with an accurate milliliter measuring device.

• A household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions.
• Ask your pharmacist to recommend an appropriate press-in bottle adapter and oral dispensing syringe and for instructions for measuring the correct dose (an oral dispensing syringe is not included with Imkeldi).
• Wear disposable gloves while preparing, withdrawing, taking, or giving Imkeldi to avoid direct contact with the medicine.
• See the Imkeldi Package Insert for detailed Instructions for Use.

The dose of Imkeldi should be taken with a meal and a large glass of water. Do not take Imkeldi on an empty stomach.

General information

Imatinib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

You will also need frequent tests to check your liver function.

Do not stop using imatinib without your doctor’s advice.

Store at room temperature away from moisture and heat.

Imatinib dosing information

Usual Adult Dose of Imatinib for Chronic Myelogenous Leukemia:

Chronic phase: 400 mg orally once a day
Accelerated phase or blast crisis: 600 mg orally once a day

A dose increase may be considered in the absence of a severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6 to 12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response:
-Disease progression chronic phase: 600 mg orally once a day
-Disease progression accelerated phase or blast crisis: 400 mg orally 2 times a day

Uses:
-Newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase
-Patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after the failure of interferon-alpha therapy

Usual Adult Dose of Imatinib for Acute Lymphoblastic Leukemia:

600 mg orally daily

Use: For relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)

Usual Adult Dose of Imatinib for Myeloproliferative Disorder:

400 mg orally once a day

Comments:
-Determine PDGFRb gene rearrangement status before initiating therapy.

Use: For patients with myelodysplastic/myeloproliferative (MDS/MPD) diseases associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements

Usual Adult Dose of Imatinib for Myelodysplastic Disease:

400 mg orally once a day

Comments:
-Determine PDGFRb gene rearrangement status before initiating therapy.

Use: For patients with myelodysplastic/myeloproliferative (MDS/MPD) diseases associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements

Usual Adult Dose of Imatinib for Systemic Mastocytosis:

-For patients with ASM without the D816V c-Kit mutation: 400 mg orally daily
-If c-Kit mutational status is not known or unavailable: 400 mg orally daily may be considered for patients with ASM not responding satisfactorily to other therapies.
-For patients with ASM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR alpha, a starting dose of 100 mg/day is recommended. A dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
-For patients with ASM associated with eosinophilia (a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR alpha: 100 mg orally daily; a dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Comments:
-Determine D816V c-Kit mutation status prior to initiating treatment.

Use: For patients with aggressive systemic mastocytosis without the D816V c-Kit mutation

Usual Adult Dose of Imatinib for Hypereosinophilic Syndrome:

-For patients with HES/CEL: 400 mg orally daily
-For patients with HES/CEL with demonstrated FIP1L1-PDGFR alpha fusion kinase: 100 mg orally daily; dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Use: For patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase negative or unknown

Usual Adult Dose of Imatinib for Chronic Eosinophilic Leukemia:

-For patients with HES/CEL: 400 mg orally daily
-For patients with HES/CEL with demonstrated FIP1L1-PDGFR alpha fusion kinase: 100 mg orally daily; dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Use: For patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase negative or unknown

Usual Adult Dose of Imatinib for Dermatofibrosarcoma Protuberans:

100 mg orally daily

Use: For patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

Usual Pediatric Dose of Imatinib for Chronic Myelogenous Leukemia:

1 year and older:
340 mg/m² orally once a day or 170 mg/m² orally 2 times a day
Maximum Dose: 600 mg daily
Comments:
-Therapy can be given as a once-daily dose or the daily dose may be split into 2 doses, with one portion dosed in the morning and one portion in the evening.
-There is no experience with this drug in children under 1 year of age.

Use:
-Newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase.

What happens if I miss a dose?

Take your dose as soon as you can, making sure you also eat a meal and drink a large glass of water. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking imatinib?

Imatinib may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Grapefruit may interact with imatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Do not crush Gleevec tablets. If a tablet accidentally gets crushed, avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. 

Imatinib side effects

Get emergency medical help if you have signs of an allergic reaction to imatinib (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• fluid retention – shortness of breath (even while lying down), swelling, rapid weight gain;
• kidney problems – little or no urination, swelling in your feet or ankles;
• fluid build-up in the lungs – pain when you breathe, wheezing, gasping for breath, cough with foamy mucus;
• liver problems – upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• low blood cell counts – fever, cold or flu symptoms, easy bruising, unusual bleeding, mouth sores, pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• signs of tumor cell breakdown – confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth; or
• thyroid symptoms – tiredness, dry skin, hair loss, constipation, depression, slow heart rate, weight gain, feeling more sensitive to cold temperatures.

Imatinib can affect growth in children and teenagers. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common imatinib side effects may include:

• fluid retention;
• nausea, vomiting, stomach pain, diarrhea;
• joint or muscle pain;
• skin rash; or
• feeling tired.

What is Imdelltra?

Imdelltra (tarlatamab) is an immunotherapy treatment that may be used to treat adults with extensive-stage small cell lung cancer (ES-SCLC) which has progressed after receiving platinum-based chemotherapy.

• ES-SCLC is when small cell lung cancer has spread throughout the lung or to other parts of the body.
• Imdelltra is given by intravenous infusion (infusion into a vein) by a healthcare provider.

Imdelltra (full biologic name tarlatamab-dlle) is a bispecific T-cell engager with two arms that activate a patient’s T-cells to attack Delta-like ligand (DLL3)-expressing SLCL. One part of Imdelltra works by binding to DLL3 expressed on the surface of cells, including tumor cells, and the other part binds to CD3 expressed on the surface of T-cells. This brings T-cells and tumor cells closer, activating the immune system directly at the cancer site.

Imdelltra was FDA-approved on 16 May 2024 under the accelerated approval designation. Continued approval may be contingent upon continued benefits seen in clinical trials.

How effective is Imdelltra?

Imdelltra is significantly more effective than historical treatments for EC-SCLC. Even though SCLC is rare (2% to 5% of lung cancer cases), it’s aggressive, there are few treatment options, and survival is poor.

Results from the phase 2 DeLLphi-301 trial by Amgen reported that Imdelltra 10 mg infusion given every 2 weeks reduced tumors in 40% of ES-SCLC patients with a median overall survival of 14.3 months (previous survival duration with no treatment/other treatments is approximately 5 months).

Imdelltra side effects

The most common side effects of Imdelltra affecting 20% or more people include:

• Cytokine release syndrome
• Fatigue and tiredness
• Fever
• A bad or metallic taste in your mouth
• Decreased appetite
• Muscle and bone pain
• Constipation
• Nausea.

The most common severe abnormal lab test results with Imdelltra include decreased white blood cells, decreased sodium, increased uric acid, decreased red blood cells, increased blood clotting time, decreased potassium, increased liver enzymes, and decreased platelets.

Serious side effects and warnings

Imdelltra comes with a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).

Cytokine Release Syndrome (CRS). CRS is a condition that happens when your immune system responds to infection and immunotherapy drugs more aggressively than it should. It is common during Imdelltra treatment and can be serious and life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:

• Fever of 100.4°F (38°C) or higher
• Low blood pressure
• Tiredness
• Fast heartbeat or dizziness
• Headache
• Shortness of breath or trouble breathing
• Nausea and vomiting
• Confusion, restlessness, or feeling anxious
• Problems with balance and movement, such as trouble walking
• Heart, liver, or kidney problems
• Unusual bleeding or bleeding that lasts a long time.

Low blood cell counts (cytopenias). Decreased blood cell counts are common with Imdelltra and can also be severe and may include:

• Low white blood cell counts (neutropenia) which can increase your risk for infection.
• Low red blood cell counts (anemia) which can cause tiredness and shortness of breath.
• Low platelet counts (thrombocytopenia) which can cause bruising or bleeding problems.

Infections. Imdelltra can cause serious infections that can be life-threatening and may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection, such as:

• Fever of 100.4°F (38°C) or higher
• Painful rash
• Cough
• Sore throat
• Chest pain
• Pain during urination
• Tiredness
• Feeling weak or generally unwell
• Shortness of breath.

Liver problems. Imdelltra can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any signs or symptoms of liver problems, including:

• Tiredness
• Loss of appetite
• Pain in your right upper stomach area (abdomen)
• Dark urine
• Yellowing of your skin or the white part of your eyes.

Allergic reactions. Imdelltra can cause allergic reactions that can be severe. Go to the nearest emergency room or get medical help right away if you develop any signs or symptoms of a severe allergic reaction during treatment such as:

• Shortness of breath or trouble breathing
• Pain or tightness in your chest and back
• Wheezing
• Coughing
• Feeling lightheaded or dizzy
• Rash.

Neurologic problems, that can be serious or life-threatening. These may happen days or weeks after you receive Imdelltra. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:

• Trouble speaking, memory loss, or personality changes
• Confusion, feeling disoriented, slow thinking, or not being able to think clearly
• Seizures
• Problems with walking, loss of balance, or coordination
• Weakness or numbness of your arms or legs
• Shaking (tremors)
• Headache
• Numbness or tingling of your hands or feet
• Trouble sleeping
• Fainting or loss of consciousness
• Feeling like you have no energy.

May cause harm to an unborn baby.

It is not known if Imdelltra is safe and effective in children.

These are not all of the possible side effects of Imdelltra. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Before taking

Before receiving Imdelltra, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection or signs of an infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Your healthcare provider will do bloodwork before you start and during treatment with Imdelltra and monitor you for signs or symptoms of these serious side effects during treatment and may temporarily or completely stop treatment if you develop certain serious side effects.

Pregnancy

Imdelltra may harm your unborn baby. For females who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Imdelltra and you should use an effective form of birth control (contraception) during treatment, and for 2 months after your last dose.

Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment.

Breastfeeding

It is not known if Imdelltra passes into your breast milk. Do not breastfeed during treatment with Imdelltra and for 2 months after the last dose.

How is Imdelltra administered?

Imdelltra is administered by a healthcare provider in a clinic or hospital.

• It is administered by intravenous (IV) infusion through a needle placed in a vein.
• The infusion will take about 1 hour.

Your Imdelltra treatment schedule is divided into cycles that are usually 28 days (4 weeks) long.

• Your healthcare provider will decide how many treatment cycles you will receive.
• Due to the risk of CRS, you will receive Imdelltra on a “step-up dosing schedule”:
• This means you will receive a smaller dose of Imdelltra on Day 1 of your first treatment cycle (Cycle 1).
• You will receive the full treatment dose on Day 8 and Day 15 of Cycle 1.
• You will receive the full treatment dose 1 time every 2 weeks after Day 15 of Cycle 1.
• If your dose of Imdelltra is delayed for any reason, you may need to repeat the “step-up dosing schedule”.

Before receiving your Day 1 and Day 8 doses of Cycle 1, you will be given a medicine to help reduce your risk of CRS. This will be given into your vein by intravenous (IV) infusion.

• You will also receive IV fluids after each of your Cycle 1 doses of Imdelltra (on Day 1, Day 8, and Day 15). Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

Due to the risk of CRS and neurologic problems, you will receive the following monitoring during treatment

• For Day 1 and Day 8 of Cycle 1 doses, your healthcare provider will monitor you for 22 to 24 hours from the start of the Imdelltra infusion in an appropriate healthcare setting that can manage these side effects.
  • You should stay within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the Imdelltra infusion after your Day 1 and Day 8 of Cycle 1 doses and be accompanied by a caregiver.
• For Day 15 of Cycle 1 and Cycle 2 doses, your healthcare provider will watch you for 6 to 8 hours after the Imdelltra infusion.
• For Cycle 3 and Cycle 4 doses, your healthcare provider will watch you for 3 to 4 hours after the Imdelltra infusion.
• For Cycle 5 and later doses, your healthcare provider will watch you for 2 hours after the Imdelltra infusion.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with Imdelltra, as well as other side effects, and treat you as needed. You may be hospitalized if you develop signs or symptoms of CRS or neurologic problems during treatment.

• Your healthcare provider may temporarily stop or completely stop your treatment with Imdelltra if you develop CRS, neurologic problems, or any other severe side effects.

What should I avoid while receiving Imdelltra?

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities, including work-related activities, during treatment with Imdelltra if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

What other drugs will affect Imdelltra?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Specific drug interactions are not listed in the product information for Imdelltra but other medications that have similar side effects, for example, cause CRS, low blood cell counts, liver problems, affect the immune system, or cause neurological problems, may potentially interact.

Talk to your healthcare provider about interactions with Imdelltra or refer to the Imdelltra Package Insert.

Storage

Your healthcare provider will store Imdelltra and the IV Solution Stabilizer (IVSS) vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze.

May be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect it from light.

Imdelltra ingredients

Active ingredients: tarlatamab-dlle

Inactive ingredients: glutamic acid, polysorbate 80, sucrose, and sodium hydroxide.

Inactive ingredients of IV solution stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for Injection.

Available in 1mg and 10mg vials that require reconstitution and further dilution.

Who makes Imdelltra?

Amgen Inc., makes Imdelltra

Imdelltra Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Imdelltra.Imdelltra (tarlatamab-dlle) – Amgen Inc.

What is Imbruvica?

Imbruvica (ibrutinib) is used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) in certain patients. Imbruvica helps slow cancer progression in CLL, SLL, and WM and slow disease progression in cGVHD. 

Imbruvica is a targeted therapy it is not a a chemotherapy drug.

Imbruvica works by inhibiting the enzyme Bruton tyrosine kinase (BTK), which is part of a crucial signaling pathway in certain cancers, telling them to grow and divide uncontrollably.  By blocking Bruton tyrosine kinase, Imbruvica helps stop cancer cells from multiplying and triggers cancer cells to die.

Imbruvica is taken once a day as a capsule, tablet, or oral suspension.

Imbruvica FDA approval was first granted on November 13, 2013.

What is Imbruvica used for?

Imbruvica is FDA-approved (Imbruvica indications) for:

• chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adults
• chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion in adults
• Waldenström’s macroglobulinemia (WM) in adults
• chronic graft versus host disease (cGVH), after failure of one or more lines of systemic therapy for adult and pediatric patients aged 1 year and older.

Imbruvica is no longer indicated for mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL).

How does Imbruvica work?

Imbruvica’s mechanism of action is as a BTK inhibitor by directly inhibiting Bruton’s tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue on the enzyme, preventing its activity. BTK works as a signaling molecule for the B-cell antigen receptor (BCR) and cytokine receptor pathways. Activation of these pathways causes the proliferation of B cells and other interactions, and inhibition has been shown to reduce the growth and spread of malignant B cells. 

Imbruvica belongs to the class of medicines known as BTK inhibitors.

Imbruvica side effects

Common side effects of Imbruvica

Common Imbruvica side effects may include: 

• Diarrhea 59%
• Bruising 51%
• Upper respiratory tract infection 47%
• Fatigue, tiredness 33%
• Musculoskeletal pain 25%
• Rash 25%
• Fever 24%
• Joint pain 24%
• Constipation 22%
• Sinusitis 22%
• Cough 22%
• Swelling of extremities 22%
• Dizziness 20%
• Nausea 20%
• Mouth ulcers, stomatitis 20%
• Headache 18%
• Muscle spasms 18%
• Vomiting 18% 
• High blood pressure 16%
• Low appetitie 16% 
• Petechiae 16%
• Skin infection 16%
• Abdominal pain 14%
• Weakness, lack of energy and strength 14%
• Oropharyngeal pain, pain in the middle area or the throat 14%
• Chills 12%
• Difficulty breathing 12%
• Dyspepsia, indigestion 12%
• Pneumonia 12%
• Urinary tract infection 12%
• Second cancers 10%

These common side effects occurred in 10% or more of Imbruvica patients in the CLL/SLL clinical trial called Study 1102.

This medicine also cause blood test abnormalities including decreased platelets, neutrophils and hemoglobin levels. Your HCP will monitor your blood tests regularly.

Serious side effects of Imbruvica

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Imbruvica may cause other serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;
• heart problems – swelling, rapid weight gain, feeling short of breath;
• heart rhythm disorders – dizziness, chest pain, shortness of breath, fast or irregular heart rate, feeling light-headed;
• high blood pressure- severe headache, blurred vision, pounding in your neck or ears;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath;
• kidney problems – swelling, urinating less, feeling tired or short of breath;
• liver problems – stomach pain or discomfort, dark-colored urine, or yellow skin and eyes;
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Also see Warning section.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Imbruvica for CLL

Imbruvica for CLL/SLL can be used for patients:

• as a first-line treatment or in patients who have previously had treatment for their cancer, and includes patients with or without a deletion in chromosome 17 (17p deletion). 
• in combination with Gazyva (obinutuzumab) for the treatment of previously untreated patients
• in combination with rituximab (Rituxan and other brands) for the treatment of previously untreated patients.

In CLL/SLL clinical trial RESONATE-2 (NCT01722487) Imbruvica significantly prolonged CLL/SLL overall survival with a relative risk of death that was 84% lower than chlorambucil at 24 months when used as monotherapy. The estimated CLL/SLL Imbruvica survival rate at 24 months was 98% versus 85% with chlorambucil.

The median progression-free survival (PFS) was not reached for Imbruvica compared to 18.9 months for chlorambucil. Imbruvica had a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil.

Warnings

Serious hemorrhage, including intracranial or gastrointestinal hemorrhage, hematuria, and post-procedural hemorrhage has occurred in people receiving Imbruvica, 0.4% have been fatal. 39% of people reported bleeding of any grade, including purpura and petechiae. Coadministration with antiplatelet or anticoagulants may increase the risk. Your doctor will monitor for signs and symptoms of bleeding and discontinue if serious bleeding occurs. They may consider withholding Imbruivca for 3 to 7 days pre and post surgery depending on the risk of bleeding. Call your doctor at once if you have signs of bleeding inside your body, such as dizziness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

Infections. This medication affects your immune system. Serious bacterial, viral, or fungal infections have been reported with Imbruvica; 21% were Grade 3 or higher. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred, in addition to reactivation of hepatitis B. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections in patients who are at increased risk for infections. Tell your doctor if you have a fever, chills, cough, mouth sores, or other signs of infection.

Progressive multifocal leukoencephalopathy (PML) is a brain infection caused by a virus (polyomavirus JC) that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly. Tell your doctor if you have a fever, chills, cough, mouth sores, or other signs of infection.

High blood pressure (hypertension) Hypertension as a side effect occurred in 19% of 1,476 patients with B-cell malignancies taking Imbruvica in clinical trials. Grade 3 or greater hypertension affects 8% of patients and the rate increases the longer the medicine is taken. BP should be measured regularly and treated as necessary.

Serious cardiac arrhythmias and cardiac disease, including atrial fibrillation, atrial flutter, ventricular arrhythmias, heart failure, and sudden death, have been reported in patients treated with Imbruvica. The risk is more likely in those with cardiac risk factors, high blood pressure, and acute infections. High blood pressure occurred in 19% of people prescribed Imbruvica in clinical trials. Monitor yourself for signs and symptoms of cardiac arrhythmias (such as palpitations, dizziness, dizziness when standing, and shortness of breath) and report these to your doctor immediately. Your doctor will check your blood pressure regularly.

Blood count abnormalities, including neutropenia, thrombocytopenia, and anemia, have occurred in people receiving Imbruvica. Your doctor will perform regular blood counts and interrupt treatment, reduce the dose, or discontinue treatment as warranted.

Second Primary Malignancies. Using Imbruvica may increase your risk of developing other cancers, such as non-melanoma skin cancer. Ask your doctor about this risk and what skin symptoms to watch for. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tumor Lysis syndrome has been reported infrequently with Imbruvica. Symptoms include nausea and vomiting, diarrhea, and muscle cramps. If you have any symptoms like these, report them to your doctor.

Imbruvica can cause fetal harm when administered to a pregnant woman, including malformations. Women should use effective contraception and avoid becoming pregnant while taking Imbruivca and for 1 month after the last dose. Men should avoid fathering a child during treatment and for 1 month after the last dose.

Before taking this medicine

To make sure Imbruvica is safe for you, tell your doctor if you have ever had:

• an infection
• bleeding problems
• take a blood thinner such as warfarin
• a heart rhythm disorder
• risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol)
• low blood cell counts
• recent surgery or plan to have surgery, medical or dental procedure
• liver disease.

Taking Imbruvica may increase your risk of developing other cancers. Ask your doctor about this risk.

Pregnancy

Ibrutinib can harm an unborn baby if the mother or the father is using this medication.

If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using Imbruvica and for at least 1 month after your last dose. If you are a man, use birth control if your sex partner can get pregnant. Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs.

Breastfeeding

Do not breastfeed while using Imbruvica, and for at least 1 week after your last dose.

How should I take Imbruvica?

Take Imbruvica exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking Imbruvica.

• Swallow the Imbruvica tablet or capsule whole and do not crush, chew, break, or open it.
• Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon), then take the medicine.

Tell your healthcare providers if you have a planned surgery.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

You may get infections or bleed more easily. You will need frequent blood and medical tests.

Imbruvica dosing information

The dose of Imbruvica varies depending on the condition being treated:

Imbruvica Dosage for Adults with CLL/SLL and WM

• 420mg once daily.

Imbruvica Dosage for cGVHD

• Patients 12 years and older: 420mg once daily
• Patients 1 year old to less than 12 years old: 240mg/m² once daily (up to a maximum dosage of 420mg once daily).

Imbruvica Dosage forms and strengths

• Capsules: 70 mg and 140 mg
• Tablets: 140 mg, 280 mg, and 420 mg
• Oral suspension: 70 mg/mL

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take 2 doses on the same day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking this medicine?

Avoid grapefruit and Seville oranges with Imbruvica, as this may cause side effects. Avoid consuming grapefruit products and orange marmalades.

What other drugs will affect Imbruvica?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

• Moderate to strong CYP3A Inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, ritonavir, grapefruit juice, erythromycin, or verapamil
• Moderate to strong CYP3A inducers, such as glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid coadministration.

Other drugs may interact with ibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

I

Imbruvica Package Insert 

HCPs and patients often use the Imbruvica Package Insert (PI) for more detailed information about this medicine. The Imbruvica Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Imbruvica Prescribing Information (PI) or FDA label.

Imbruvica and Medicare

Because of the prescription drug law, known as the Inflation Reduction Act, Medicare is able to negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

Imbruvica is one of 10 drugs covered under Medicare Part D that were selected in 2024 for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation is effective from 2026.

Ingredients

Active ingredient: ibrutinib.

• Tablets are supplied in three strengths: 140mg, 280mg, 420mg
• Capsules are supplied in two strengths: 70mg and 140mg
• Oral suspension: 70mg/mL. The bottle contains 108mL suspension in a 150mL bottle.

Inactive ingredients:

• Capsules: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink.
• Tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets).
• Oral suspension: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose, and carboxymethylcellulose sodium, purified water, and sucralose.

What is Imdur?

Imdur is a nitrate that dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Imdur is an extended release tablet used to prevent angina attacks (chest pain).

Imdur will not treat an angina attack that has already begun.

Warnings

You should not take erectile dysfunction medicine (Viagra, Cialis, Levitra, Stendra, Staxyn, sildenafil, avanafil, tadalafil, vardenafil) while you are taking Imdur. Taking these medicine together can cause a sudden and serious decrease in blood pressure.

Seek emergency medical attention if you have early symptoms of a heart attack (chest pain or pressure, pain spreading to your jaw or shoulder, sweating, general ill feeling).

Do not stop taking this medicine suddenly. Stopping suddenly could cause a severe angina attack.

Isosorbide mononitrate can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medication. Do not stop taking Imdur. Ask your doctor before using any headache pain medication.

Use this medicine regularly to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

Before taking this medicine

You should not use Imdur if:

• you are allergic to isosorbide mononitrate, isosorbide dinitrate, or nitroglycerin; or
• you have early signs of a heart attack (chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating).

You should not take erectile dysfunction medicine (Viagra, Cialis, Levitra, Stendra, Staxyn, sildenafil, avanafil, tadalafil, vardenafil) while you are taking Imdur. Taking these medicines together can cause a sudden and serious decrease in blood pressure.

To make sure Imdur is safe for you, tell your doctor if you have:

• congestive heart failure;
• kidney disease; or
• low blood pressure.

It is not known whether Imdur will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether isosorbide mononitrate passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Imdur?

Take Imdur exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. If you use too much isosorbide mononitrate, it might stop working as well in controlling your condition.

Try to rest or stay seated when you take this medicine (may cause dizziness or fainting).

Do not crush, chew, or break an extended-release Imdur tablet. Swallow it whole.

You may have very low blood pressure while taking Imdur. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Prolonged illness can lead to a serious electrolyte imbalance, making it dangerous for you to use this medicine.

Use Imdur regularly to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

You should not stop using Imdur suddenly or you could have a severe attack of angina. Keep this medicine on hand at all times. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of isosorbide mononitrate can be fatal.

Overdose symptoms may include a severe throbbing headache, fever, confusion, severe dizziness, fast or pounding heartbeats, vision problems, nausea, vomiting, stomach pain, bloody diarrhea, trouble breathing, sweating, cold or clammy skin, fainting, and seizure (convulsions).

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. Alcohol may increase certain side effects of Imdur (dizziness, drowsiness, feeling light-headed, or fainting).

Imdur side effects

Get emergency medical help if you have signs of an allergic reaction to Imdur: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• worsening angina pain;
• fast or slow heart rate; or
• pounding heartbeats or fluttering in your chest.

Imdur can cause severe headaches. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking this medicine to avoid headaches. Ask your doctor before using any headache pain medication.

Common Imdur side effects may include:

• headache; or
• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Dosing information

Usual Adult Dose for Angina Pectoris Prophylaxis:

EXTENDED RELEASE:
30 to 60 mg orally once a day in the morning

Maximum dose: 240 mg orally once a day in the morning

Comments:
-Swallow whole (do not crush or chew) with half-glass of fluid.
-Start at low end of dosing range for elderly patients.

Use: Prevention of angina pectoris due to coronary artery disease; onset of action is not sufficiently rapid to be useful in aborting an acute anginal episode.

Usual Adult Dose for Angina Pectoris:

EXTENDED RELEASE:
30 to 60 mg orally once a day in the morning

Maximum dose: 240 mg orally once a day in the morning

Comments:
-Swallow whole (do not crush or chew) with half-glass of fluid.
-Start at low end of dosing range for elderly patients.

Use: Prevention of angina pectoris due to coronary artery disease; onset of action is not sufficiently rapid to be useful in aborting an acute anginal episode.

What other drugs will affect Imdur?

Taking Imdur with certain other medicines can cause severely low blood pressure. This includes medicine to treat erectile dysfunction or pulmonary arterial hypertension. Serious, life-threatening side effects may occur.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• avanafil (Stendra);
• a diuretic or “water pill”;
• nitroglycerin;
• riociguat (Adempas);
• sildenafil (Viagra, Revatio);
• tadalafil (Cialis, Adcirca); or
• vardenafil (Levitra, Staxyn).

What is Imfinzi?

Imfinzi (durvalumab) is an immunotherapy used to treat cancer, including certain non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bile duct and gallbladder cancer, hepatocellular carcinoma, endometrial cancer and muscle invasive bladder cancer (MIBC). Imfinzi may help increase overall survival, lower the chance of cancer spreading, and help shrink tumors, depending on the type of cancer. Imfinzi works by helping the immune system find, recognize, and fight cancer cells.

Imfinzi is given as an infusion into a vein every 2, 3, or 4 weeks, depending on your condition. Other medicines may be part of your treatment plan, depending on your cancer type.

Imfinzi FDA approval was granted on May 1, 2017, for the company AstraZeneca, originally for Advanced Bladder Cancer, but FDA approval has since be extended for use in more cancer types.

How does Imfinzi work?

Imfinzi works by binding and blocking the PD-L1 protein on the outside of cancer cells, which means your immune system can then find and attack the cancer cells to help slow cancer spreading and increase survival. Imfinzi’s class of medicines is called checkpoint inhibitors.

Imfinzi mechanism of action (MOA) is as a programmed death-ligand 1 (PD-L1) blocking antibody. It binds and blocks PD-L1, so there is no interaction with PD-1 and CD80. This means that the immune response is now activated to work against the cancer cells.

Imfinzi can be used for cancers that have a protein called PD-L1 on the outside of the cancer cell. The PD-L1 protein helps the cancer cells hide it from the immune system so cancer cells can survive and multiply. When Imfinzi blocks PD-L1 it means the immune system is able to find cancers and destroy them.

What is Imfinzi used for?

Imfinzi indications are non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, hepatocellular carcinoma, endometrial cancer, and muscle invasive bladder cancer (MIBC) in specific patients. Imfinzi is an FDA-approved prescription medicine to treat adults with:

Non-small cell lung cancer (NSCLC)

• Non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements who have with resectable (tumors ≥ 4 cm and/or node positive). To be used in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinizi continued as a single agent as adjuvant treatment after surgery.
• Unresectable Stage III NSCLC in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi is to be used as a single agent.
• Metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. Imfinzi, Imjudo (tremelimumab-actl) and platinum-based chemotherapy are to be used in combination for the treatment regime.

Small cell lung cancer (SCLC) 

• in combination with the chemotherapy medicines etoposide and carboplatin or cisplatin when cancer has spread within your lungs or to other parts of the body
• as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

Biliary tract cancer (including cancer of the bile ducts and gallbladder cancer) in combination with the chemotherapy medicines gemcitabine and cisplatin when cancer has spread to nearby tissues or other parts of the body

Hepatocellular carcinoma (unresectable) Imfinzi, Imjudo (tremelimumab-actl) are used in combination.

Endometrial cancer that has spread (advanced) or come back (recurrent) and tests show the tumor is mismatch repair deficient (dMMR), Imfinzi is used with carboplatin plus paclitaxel followed by single-agent Imfinzi.

Bladder cancer that has invaded the muscle. Imfinzi is used in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Imfinizi as adjuvant treatment following radical cystectomy.

Imfinzi side effects

Common Imfinzi side effects

Common Imfinzi side effects include shortness of breath (dyspnea), cough, rash, tiredness (fatigue), cold symptoms (respiratory tract infections) inflammation of the lungs (pneumonitis) when used as a single agent for Stage III NSCLC.

When used with other cancer treatments, common Imfinzi side effects may include nausea, constipation, decreased appetite, feeling weak or tired, bone or muscle pain, cough, feeling short of breath, cold symptoms such as stuffy nose, sneezing, sore throat, abdominal pain, fever, itchy skin, rash, painful urination, hair loss, vomiting, nerve inflammation (causing symptoms such as numbness, weakness, tingling, or burning), changes blood tests including decreased magnesium, increased ALT, and increased AST. Side effects profiles are dependent on the specific combination of therapies.

Immune-mediated hypothyroidism was reported in 14% of people receiving Imfinzi in combination with carboplatin and paclitaxel. Events resolved in some patients, but all required endocrine therapy.

Serious Imfinzi side effects

Imfinzi may cause serious side effects including severe allergic reactions. Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the Imfinzi injection. Tell your caregiver right away if you feel light-headed or itchy or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

This medicine causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

• chest pain, new or worsening cough, feeling short of breath;
• severe stomach pain, diarrhea, bloody or tarry stools;
• new or worsening skin rash, itching, or blistering;
• fever, flu-like symptoms;
• pain or burning when you urinate;
• problems in other organs – mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems;
• liver problems – loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urination, red or pink urine, swelling in your feet or ankles;
• transplant rejection – rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; or
• signs of a hormonal disorder – unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Imfinzi works by causing your immune system to attack tumor cells but it may also cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands.

Call your doctor at once if you have new or unusual symptoms, such as: tiredness, mood changes, headaches, vision problems, muscle weakness, stomach problems, weight changes, skin rash, hair loss, bleeding or bruising, yellowing of your skin or eyes, increased or decreased urination, dark urine, bloody or tarry stools, worsening cough, chest pain, or trouble breathing.

Infusion-Related Reactions. Your infusion may be slowed, interrupted or permanently discontinued if you have an infusion-related reaction, depending on the severity of the reaction.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Embryo-Fetal Toxicity: This medicine can cause fetal harm. Females of reproductive potential should be advised of the potential risk to a fetus and should use effective contraception.

Before taking this medicine

You should not use this infusion if you are allergic to the active ingredient, durvalumab, or any of the inactive ingredients.

To make sure this medicine is safe for you, tell your doctor if you have an active infection or if you have ever had:

• an organ transplant or a stem cell transplant (recent or planned);
• lung disease or breathing problems;
• liver disease;
• radiation treatment of your chest area;
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome, or
• an autoimmune disorder such as lupus, ulcerative colitis, or Crohn’s disease.

Pregnancy

Imfinzi may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

Do not breastfeed while using medicine, and for at least 3 months after your last dose.

How is Imfinzi given?

Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 hour to complete.

Imfinzi Dosing information

Usual Adult Dose for Small Cell Lung Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 4 weeks as a single agent until disease progression, unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Use: First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin.

Usual Adult Dose for Biliary Tract Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent until disease progression or until unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or until unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Use: Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.

Usual Adult Dose for Unresectable Hepatocellular Carcinoma:

Less than 30 kg:
20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Greater than or equal to 30 kg:
1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Use: The treatment of adult patients with unresectable hepatocellular carcinoma in combination with tremelimumab-actl.

Usual Adult Dose for dMMR endometrial cancer

30 kg or less:
15 mg/kg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by Imfinzi 20 mg/kg every 4 weeks as a single agent Until disease progression or unacceptable toxicity.

Greater than 30 kg:

1,120 mg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by Imfinzi 1,500 mg every 4 weeks as a single agent.

What is imipramine?

Imipramine is a tricyclic antidepressant used to treat symptoms of depression. Imipramine is sometimes used to treat bed-wetting in children ages 6 and older.

Imipramine may also be used for purposes not listed in this medication guide.

Imipramine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Imipramine may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;
• tunnel vision, eye pain or swelling, or seeing halos around lights;
• a light-headed feeling, like you might pass out;
• new or worsening chest pain, pounding heartbeats or fluttering in your chest;
• sudden numbness or weakness, problems with vision, speech, or balance;
• fever, sore throat;
• confusion, hallucinations, unusual thoughts or behavior;
• painful or difficult urination;
• seizure (convulsions); or
• jaundice (yellowing of the skin or eyes).

Common side effects of imipramine may include:

• increased blood pressure;
• tingly feeling, weakness, lack of coordination;
• dry mouth, nausea, vomiting; or
• breast swelling (in men or women).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

You should not use imipramine if you are allergic to it, or if:

• you recently had a heart attack; or
• you are allergic to other antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, nortriptyline, protriptyline, or trimipramine).

Do not use imipramine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• heart disease, stroke, or seizures;
• bipolar disorder (manic-depression), schizophrenia or other mental illness;
• kidney or liver disease;
• overactive thyroid;
• narrow-angle glaucoma; or
• problems with urination.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

It is not known whether imipramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using imipramine.

Do not give this medicine to a child without medical advice. Imipramine is not approved to treat depression in anyone younger than 18 years old. Imipramine should not be used to treat bed-wetting in a child younger than 6 years old.

How should I take imipramine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Tell your doctor if you have a planned surgery.

Call your doctor if your symptoms do not improve, or if they get worse.

You should not stop using imipramine suddenly. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of imipramine can be fatal.

Overdose symptoms may include irregular heartbeats, feeling like you might pass out, seizures, or coma.

What should I avoid while taking imipramine?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with imipramine.

Avoid driving or hazardous activity until you know how imipramine will affect you. Your reactions could be impaired.

Avoid exposure to sunlight or tanning beds. Imipramine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect imipramine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking imipramine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

What is Imitrex?

Imitrex is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Imitrex is available as oral tablets, a nasal spray, and as an injection. It used to treat migraine headaches in adults. Imitrex will only treat a headache. It will not prevent headaches or reduce the number of attacks.

Imitrex should not be used to treat a common tension headache or a headache that causes loss of movement on one side of your body. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.

Warnings

You should not use Imitrex if you have uncontrolled high blood pressure, heart problems, certain heart rhythm disorders, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Imitrex will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Do not use Imitrex within 24 hours before or after using any other migraine headache medicine.

Before taking this medicine

You should not use Imitrex if you are allergic to sumatriptan, or if you have ever had:

• heart problems, or a stroke (including “mini-stroke”);
• coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
• circulation problems affecting your legs, arms, stomach, intestines, or kidneys;
• a heart disorder called Wolff-Parkinson-White syndrome;
• uncontrolled high blood pressure;
• severe liver disease; or
• a headache that seems different from your usual migraine headaches.

Do not use Imitrex if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, serious infections, or prevention of nausea and vomiting. These medicines may interact with sumatriptan and cause a serious condition called serotonin syndrome.

To make sure Imitrex is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• epilepsy or other seizure disorder;
• high blood pressure, a heart rhythm disorder; or
• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or being older than 40 and a man).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Sumatriptan can pass into breast milk. Do not breast-feed within 12 hours after using Imitrex. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Imitrex is not approved for use by anyone younger than 18 years old.

How should I use Imitrex?

Use Imitrex as soon as you notice headache symptoms. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Take a Imitrex tablet whole with a full glass of water. Do not split the tablet.

After using Imitrex: If your headache does not completely go away, or goes away and comes back, use a second dose if it has been at least 2 hours since your first dose.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Do not take more than 200 milligrams of oral Imitrex within 24 hours.

Do not use more than 40 milligrams of Imitrex nasal spray within 24 hours.

Call your doctor if your symptoms do not improve, or if you have more than 4 headaches in one month (30 days).

Store at room temperature away from moisture, heat, and light. Do not store in a refrigerator. Do not freeze.

Dosing information

Usual Adult Dose for Migraine:

Use only after a clear diagnosis of migraine has been established

Oral:
Initial dose: 25 mg, 50 mg, or 100 mg orally, once
-If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed
-Oral doses of 50 and 100 mg may provide greater relief than 25 mg; however, a 100 mg dose may not provide greater effect than a 50 mg dose
Maximum dose: 200 mg per 24 hours

Intranasal:
Nasal spray: Initial dose: 5 mg, 10 mg, or 20 mg into one nostril, once
-Administer the 5 and 20 mg doses as a single spray in 1 nostril; the 10 mg dose may be administered as 5 mg into each nostril
-If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed
Maximum dose: 40 mg per 24 hours

Comments:
-Treatment should be started at the first sign of a migraine headache, or associated symptoms such as nausea, vomiting, or photophobia; this drug should not be used for migraine prophylaxis.
-Higher doses may have a greater effect, but also carry a greater risk of adverse reactions.
-The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Use: For the acute treatment of migraine with or without aura.

What happens if I miss a dose?

Since Imitrex is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include tremors, skin redness in your arms or legs, weakness, loss of coordination, breathing problems, blue-colored lips or fingernails, vision problems, or a seizure (convulsions).

What should I avoid while using Imitrex?

Do not use Imitrex within 24 hours before or after using another migraine headache medicine, including:

• sumatriptan injection, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan; or
• ergot medicine such as dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Imitrex side effects

Get emergency medical help if you have signs of an allergic reaction to Imitrex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Imitrex and call your doctor at once if you have:

• sudden and severe stomach pain and bloody diarrhea;
• severe chest pain, shortness of breath, irregular heartbeats;
• a seizure (convulsions);
• severe headache, blurred vision, pounding in your neck or ears;
• blood circulation problems in your legs or feet – cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; or
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common Imitrex side effects may include:

• pain or tight feeling in your chest, throat, or jaw;
• pressure or heavy feeling in any part of your body;
• numbness or tingling, feeling hot or cold;
• dizziness, drowsiness, weakness;
• unusual or unpleasant taste in your mouth after using the nasal medicine;
• pain, burning, numbness, or tingling in your nose or throat after using the nasal medicine; or
• runny or stuffy nose after using the nasal medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Imitrex?

Using Imitrex while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:

• medicine to treat depression or a psychiatric disorder;
• medicine for Parkinson’s disease;
• medicine for serious infections;
• herbal products;
• stimulant medicine;
• opioid medicine; or
• medicine to prevent nausea and vomiting.

Imodium Description

IMODIUM® (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.

IMODIUM® is available in 2mg capsules.

The inactive ingredients are: Lactose, cornstarch, talc, and magnesium stearate. IMODIUM® capsules contain FD&C Yellow No. 6.

Imodium – Clinical Pharmacology

In vitro and animal studies show that IMODIUM® (loperamide hydrochloride) acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing peristalsis, and increasing intestinal transit time. Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency.

In man, IMODIUM® prolongs the transit time of the intestinal contents. It reduces daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes. Tolerance to the antidiarrheal effect has not been observed. Clinical studies have indicated that the apparent elimination half-life of loperamide in man is 10.8 hours with a range of 9.1 – 14.4 hours. Plasma levels of unchanged drug remain below 2 nanograms per mL after the intake of a 2mg capsule of IMODIUM®. Plasma levels are highest approximately five hours after administration of the capsule and 2.5 hours after the liquid. The peak plasma levels of loperamide were similar for both formulations. Elimination of loperamide mainly occurs by oxidative N-demethylation. Cytochrome P450 (CYP450) isozymes, CYP2C8 and CYP3A4, are thought to play an important role in loperamide N-demethylation process since quercetin (CYP2C8 inhibitor) and ketoconazole (CYP3A4 inhibitor) significantly inhibited the N-demethylation process in vitro by 40% and 90%, respectively. In addition, CYP2B6 and CYP2D6 appear to play a minor role in loperamide N-demethylation. Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces. In those patients in whom biochemical and hematological parameters were monitored during clinical trials, no trends toward abnormality during IMODIUM® therapy were noted. Similarly, urinalyses, EKG and clinical ophthalmological examinations did not show trends toward abnormality.

Indications and Usage for Imodium

IMODIUM® (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. IMODIUM® is also indicated for reducing the volume of discharge from ileostomies.

Contraindications

IMODIUM is contraindicated in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients.

IMODIUM is contraindicated in patients with abdominal pain in the absence of diarrhea.

IMODIUM is not recommended in infants below 24 months of age.

IMODIUM should not be used as the primary therapy:-in patients with acute dysentery, which is characterized by blood in stools and high fever,-in patients with acute ulcerative colitis,-in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter,-in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Warnings

Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of IMODIUM® does not preclude the need for appropriate fluid and electrolyte therapy.

In general, IMODIUM should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM must be discontinued promptly when constipation, abdominal distention or ileus develop.

Treatment of diarrhea with IMODIUM is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).

Patients with AIDS treated with IMODIUM for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

IMODIUM® should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to IMODIUM®.

Precautions

General

Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of IMODIUM® (loperamide hydrochloride) should be discontinued and patients should be advised to consult their physician. Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of loperamide in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.

Information for Patients

Patients should be advised to check with their physician if their diarrhea does not improve in 48 hours or if they note blood in their stools, develop a fever or develop abdominal distention. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with IMODIUM. Therefore, it is advisable to use caution when driving a car or operating machinery.

Drug Interactions

Nonclinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with a 600 mg single dose of either quinidine, or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3- fold increase in loperamide plasma levels. Due to the potential for enhanced central effects when loperamide is coadministered with quinidine and with ritonavir, caution should be exercised when loperamide is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.

When a single 16-mg dose of loperamide is coadministered with a 600 mg single dose of saquinavir, loperamide decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on loperamide is of less clinical significance. Therefore, when loperamide is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

Carcinogenesis, mutagenesis, impairment of fertility

In an 18-month rat study with oral doses up to 40 mg/kg/day (21 times the maximum human dose of 16 mg/day, based on a body surface area comparison), there was no evidence of carcinogenesis.

Loperamide was not genotoxic in the Ames test, the SOS chromotest in E. coli, the dominant lethal test in female mice, or the mouse embryo cell transformation assay.

Fertility and reproductive performance was evaluated in rats using oral doses of 2.5, 10, and 40 mg/kg/day (females only) in a second study. Oral administration of 20 mg/kg/day (approximately 11 times the human dose based on a body surface area comparison) and higher produced strong impairment of female fertility. Treatment of female rats with up to 10 mg/kg/day by mouth (approximately 5 times the human dose based on a body surface area comparison) had no effect on fertility. Treatment of male rats with 40 mg/kg/day by mouth (approximately 21 times the human dose based on a body surface area comparison) produced impairment of male fertility, whereas administration of up to 10 mg/kg/day (approximately 5 times the human dose based on a body surface area comparison) had no effect.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day by mouth (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women. Loperamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects

In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.

Nursing Mothers

Small amounts of loperamide may appear in human breast milk. Therefore, IMODIUM is not recommended during breast-feeding.

Pediatric Use

See the “Warnings” Section for information on the greater variability of response in this age group. In case of accidental overdosage of IMODIUM® by children, see “Overdosage” Section for suggested treatment.

Adverse Reactions/Side Effects

Clinical Trial Data

The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators.

1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea

The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.

Post –marketing experience

The following adverse events have been reported:

Skin and subcutaneous tissue disorders

Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of IMODIUM

Immune system disorders
Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of IMODIUM.

Gastrointestinal disorders
Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon .

Renal and urinary disorders
Urinary retention

Nervous system disorders
Drowsiness, dizziness

General disorders and administrative site conditions
Tiredness

A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Drug Abuse and Dependence

Abuse

A specific clinical study designed to assess the abuse potential of loperamide at high doses resulted in a finding of extremely low abuse potential.

Dependence

Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of IMODIUM® (loperamide hydrochloride), was negative. Orally administered IMODIUM® (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

Overdosage

In cases of overdosage, (including relative overdose due to hepatic dysfunction), urinary retention, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults. Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of loperamide hydrochloride can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold. If vomiting occurs spontaneously upon ingestion, a slurry of 100 gms of activated charcoal should be administered orally as soon as fluids can be retained.

If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours.

If symptoms of overdose occur, naloxone can be given as an antidote. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone.

In view of the prolonged action of loperamide and the short duration (one to three hours) of naloxone, the patient must be monitored closely and treated repeatedly with naloxone as indicated. Since relatively little drug is excreted in the urine, forced diuresis is not expected to be effective for IMODIUM® (loperamide hydrochloride) overdosage.

In clinical trials an adult who took three 20mg doses within a 24 hour period was nauseated after the second dose and vomited after the third dose. In studies designed to examine the potential for side effects, intentional ingestion of up to 60 mg of loperamide hydrochloride in a single dose to healthy subjects resulted in no significant adverse effects.

Imodium Dosage and Administration

(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea

Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (IMODIUM® A-D 1 mg/7.5 mL) should be used; for ages 6 to 12, either IMODIUM® Capsules or IMODIUM® A-D Liquid may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:

Recommended First Day Dosage Schedule
Two to five years: 1 mg t.i.d. (3mg daily dose) (13 to 20 kg)
Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg)
Eight to twelve years: 2mg t.i.d. (6mg daily dose) (greater than 30 kg)

Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent IMODIUM® doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Chronic Diarrhea

Children: Although IMODIUM® has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of IMODIUM® should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.

The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. IMODIUM® administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Children under 2 Years

The use of IMODIUM in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.

Elderly

No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required in the elderly.

Renal Impairment

No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment .

Hepatic Impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM should be used with caution in such patients because of reduced first pass metabolism.

How is Imodium supplied

Capsules – each capsule contains 2 mg of loperamide hydrochloride. The capsules have a light green body and a dark green cap with “JANSSEN” imprinted on one segment and “IMODIUM” on the other segment. IMODIUM® capsules are supplied in bottles of 100.

Imodium Description

IMODIUM® (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.

IMODIUM® is available in 2mg capsules.

The inactive ingredients are: Lactose, cornstarch, talc, and magnesium stearate. IMODIUM® capsules contain FD&C Yellow No. 6.

Imodium – Clinical Pharmacology

In vitro and animal studies show that IMODIUM® (loperamide hydrochloride) acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing peristalsis, and increasing intestinal transit time. Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency.

In man, IMODIUM® prolongs the transit time of the intestinal contents. It reduces daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes. Tolerance to the antidiarrheal effect has not been observed. Clinical studies have indicated that the apparent elimination half-life of loperamide in man is 10.8 hours with a range of 9.1 – 14.4 hours. Plasma levels of unchanged drug remain below 2 nanograms per mL after the intake of a 2mg capsule of IMODIUM®. Plasma levels are highest approximately five hours after administration of the capsule and 2.5 hours after the liquid. The peak plasma levels of loperamide were similar for both formulations. Elimination of loperamide mainly occurs by oxidative N-demethylation. Cytochrome P450 (CYP450) isozymes, CYP2C8 and CYP3A4, are thought to play an important role in loperamide N-demethylation process since quercetin (CYP2C8 inhibitor) and ketoconazole (CYP3A4 inhibitor) significantly inhibited the N-demethylation process in vitro by 40% and 90%, respectively. In addition, CYP2B6 and CYP2D6 appear to play a minor role in loperamide N-demethylation. Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces. In those patients in whom biochemical and hematological parameters were monitored during clinical trials, no trends toward abnormality during IMODIUM® therapy were noted. Similarly, urinalyses, EKG and clinical ophthalmological examinations did not show trends toward abnormality.

Indications and Usage for Imodium

IMODIUM® (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. IMODIUM® is also indicated for reducing the volume of discharge from ileostomies.

Contraindications

IMODIUM is contraindicated in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients.

IMODIUM is contraindicated in patients with abdominal pain in the absence of diarrhea.

IMODIUM is not recommended in infants below 24 months of age.

IMODIUM should not be used as the primary therapy:-in patients with acute dysentery, which is characterized by blood in stools and high fever,-in patients with acute ulcerative colitis,-in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter,-in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Warnings

Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of IMODIUM® does not preclude the need for appropriate fluid and electrolyte therapy.

In general, IMODIUM should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM must be discontinued promptly when constipation, abdominal distention or ileus develop.

Treatment of diarrhea with IMODIUM is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).

Patients with AIDS treated with IMODIUM for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

IMODIUM® should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to IMODIUM®.

Precautions

General

Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of IMODIUM® (loperamide hydrochloride) should be discontinued and patients should be advised to consult their physician. Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of loperamide in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.

Information for Patients

Patients should be advised to check with their physician if their diarrhea does not improve in 48 hours or if they note blood in their stools, develop a fever or develop abdominal distention. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with IMODIUM. Therefore, it is advisable to use caution when driving a car or operating machinery.

Drug Interactions

Nonclinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with a 600 mg single dose of either quinidine, or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3- fold increase in loperamide plasma levels. Due to the potential for enhanced central effects when loperamide is coadministered with quinidine and with ritonavir, caution should be exercised when loperamide is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.

When a single 16-mg dose of loperamide is coadministered with a 600 mg single dose of saquinavir, loperamide decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on loperamide is of less clinical significance. Therefore, when loperamide is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

Carcinogenesis, mutagenesis, impairment of fertility

In an 18-month rat study with oral doses up to 40 mg/kg/day (21 times the maximum human dose of 16 mg/day, based on a body surface area comparison), there was no evidence of carcinogenesis.

Loperamide was not genotoxic in the Ames test, the SOS chromotest in E. coli, the dominant lethal test in female mice, or the mouse embryo cell transformation assay.

Fertility and reproductive performance was evaluated in rats using oral doses of 2.5, 10, and 40 mg/kg/day (females only) in a second study. Oral administration of 20 mg/kg/day (approximately 11 times the human dose based on a body surface area comparison) and higher produced strong impairment of female fertility. Treatment of female rats with up to 10 mg/kg/day by mouth (approximately 5 times the human dose based on a body surface area comparison) had no effect on fertility. Treatment of male rats with 40 mg/kg/day by mouth (approximately 21 times the human dose based on a body surface area comparison) produced impairment of male fertility, whereas administration of up to 10 mg/kg/day (approximately 5 times the human dose based on a body surface area comparison) had no effect.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day by mouth (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women. Loperamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects

In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.

Nursing Mothers

Small amounts of loperamide may appear in human breast milk. Therefore, IMODIUM is not recommended during breast-feeding.

Pediatric Use

See the “Warnings” Section for information on the greater variability of response in this age group. In case of accidental overdosage of IMODIUM® by children, see “Overdosage” Section for suggested treatment.

Adverse Reactions/Side Effects

Clinical Trial Data

The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators.

1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea

The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.

Post –marketing experience

The following adverse events have been reported:

Skin and subcutaneous tissue disorders

Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of IMODIUM

Immune system disorders
Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of IMODIUM.

Gastrointestinal disorders
Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon .

Renal and urinary disorders
Urinary retention

Nervous system disorders
Drowsiness, dizziness

General disorders and administrative site conditions
Tiredness

A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Drug Abuse and Dependence

Abuse

A specific clinical study designed to assess the abuse potential of loperamide at high doses resulted in a finding of extremely low abuse potential.

Dependence

Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of IMODIUM® (loperamide hydrochloride), was negative. Orally administered IMODIUM® (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

Overdosage

In cases of overdosage, (including relative overdose due to hepatic dysfunction), urinary retention, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults. Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of loperamide hydrochloride can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold. If vomiting occurs spontaneously upon ingestion, a slurry of 100 gms of activated charcoal should be administered orally as soon as fluids can be retained.

If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours.

If symptoms of overdose occur, naloxone can be given as an antidote. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone.

In view of the prolonged action of loperamide and the short duration (one to three hours) of naloxone, the patient must be monitored closely and treated repeatedly with naloxone as indicated. Since relatively little drug is excreted in the urine, forced diuresis is not expected to be effective for IMODIUM® (loperamide hydrochloride) overdosage.

In clinical trials an adult who took three 20mg doses within a 24 hour period was nauseated after the second dose and vomited after the third dose. In studies designed to examine the potential for side effects, intentional ingestion of up to 60 mg of loperamide hydrochloride in a single dose to healthy subjects resulted in no significant adverse effects.

Imodium Dosage and Administration

(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea

Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (IMODIUM® A-D 1 mg/7.5 mL) should be used; for ages 6 to 12, either IMODIUM® Capsules or IMODIUM® A-D Liquid may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:

Recommended First Day Dosage Schedule
Two to five years: 1 mg t.i.d. (3mg daily dose) (13 to 20 kg)
Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg)
Eight to twelve years: 2mg t.i.d. (6mg daily dose) (greater than 30 kg)

Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent IMODIUM® doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Chronic Diarrhea

Children: Although IMODIUM® has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of IMODIUM® should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.

The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. IMODIUM® administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Children under 2 Years

The use of IMODIUM in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.

Elderly

No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required in the elderly.

Renal Impairment

No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment .

Hepatic Impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM should be used with caution in such patients because of reduced first pass metabolism.

How is Imodium supplied

Capsules – each capsule contains 2 mg of loperamide hydrochloride. The capsules have a light green body and a dark green cap with “JANSSEN” imprinted on one segment and “IMODIUM” on the other segment. IMODIUM® capsules are supplied in bottles of 100.

What is Impoyz cream?

Impoyz cream is a highly potent topical steroid that may be applied to the skin to reduce inflammation and itching caused by moderate to severe plaque psoriasis in adults aged 18 years and older. It contains clobetasol propionate 0.025% and should not be used for longer than 2 weeks.

Impoyz cream is specially formulated using an ingredient called Transcutol that enhances the solubility of clobetasol and its permeation into plaques. This means that Impoyz is just as effective as other clobetasol creams but with half the usual concentration of clobetasol, which decreases its risk of side effects including absorption into the bloodstream. Transcutol is also less disrupting to the skin’s lamellar structure (a layer of lipids and water in the stratum corneum) than propylene glycol, which is traditionally used in creams to enhance drug solubility.

Impoyz was FDA approved on December 1, 2017.

Warnings

Impoyz cream contains clobetasol propionate which can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Occlusive dressings should not be used unless under the advice of the doctor because these increase the risk of side effects.

Before taking this medicine

You should not use Impoyz if you are allergic to it.

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids and Impoyz is not for use in children or young adults under the age of 18.

It is not known whether Impoyz will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use Impoyz cream, use only a small amount and for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Impoyz cream, use only a small amount and for the shortest time possible. Do not apply to the breasts.

How do I use Impoyz cream?

Apply a thin layer of Impoyz to the affected areas twice a day. Rub in gently and completely. Apply exactly as directed.

• Wash your hands after applying.
• Stop using Impoyz cream when your psoriasis is controlled but do not use it for longer than 2 weeks. If 2 weeks have passed and your psoriasis has not got any better, stop applying the cream and contact your doctor.
• If your psoriasis gets better earlier than 2 weeks, stop using Impoyz.
• Do not exceed 50g per week.
• Do not use it if your skin is thin where you want to apply it.
• Do not bandage, cover, or wrap your skin where you have applied Impoyz unless your doctor has told you to do so.
• Do not use it on your face, scalp, armpits, groin, or skin folds.
• Do not use other corticosteroid products while using Impoyz.

Impoyz should only be applied to the skin. Do not take by mouth, apply near your eyes, or insert it.

What are the side effects of Impoyz cream?

The most common side effect of Impoyz Cream includes discoloration of the skin where you have applied it.

Topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.

Other side effects reported with topical corticosteroids include:

• acne
• allergic contact dermatitis
• burning, itching, swelling, or irritation of treated skin
• dry or cracking skin
• redness or crusting around your hair follicles
• spider veins
• stretch marks, thinning skin
• rash or hives
• temporary hair loss.

If you develop a skin infection while using Impoyz your doctor may give you an antimicrobial cream to use as well. If this does not resolve the infection, your doctor may discontinue Impoyz until the infection has cleared.

Possible signs that you may be absorbing this medicine through your skin include weight gain in your face and shoulders, increased body hair, tiredness, mood changes, menstrual changes, and sexual changes.

What is Imuran?

Imuran weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Imuran is used to prevent your body from rejecting a transplanted kidney. This medicine is also used to treat symptoms of rheumatoid arthritis.

Imuran may also be used for purposes not listed in this medication guide.

Imuran side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Imuran may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Stop using Imuran and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Imuran may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Imuran may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take Imuran if you are allergic to Imuran.

You should not use Imuran to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Imuran may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking Imuran, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using Imuran for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using Imuran.

How should I take Imuran?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Imuran.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When given for kidney transplant, Imuran is usually given right before or on the day of transplant. For rheumatoid arthritis, this medicine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using Imuran as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if Imuran upsets your stomach.

You may not be able to continue taking other arthritis medications together with Imuran. Do not change your dose or dosing schedule without your doctor’s advice.

Imuran affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Imuran?

Avoid sunlight or tanning beds. Imuran can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Imuran. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What is Inbrija?

Inbrija is an inhaled prescription medicine used to treat symptoms of Parkinson’s disease that come back (OFF episodes) while you are taking another medicine called carbidopa and levodopa.

Inbrija is not to be used in place of any medicine you take daily for Parkinson’s disease.

It is not known if Inbrija is safe or effective in children.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Do not use Inbrija if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Inbrija is safe for you, tell your doctor if you have:

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• glaucoma;
• involuntary muscle movements;
• a sleep disorder that causes daytime sleepiness;
• dizziness, nausea, or fainting spells when standing from a sitting or lying position;
• mental illness or psychosis; or
• an intense urge or compulsive behavior (such as sexual urges, binge eating, gambling, or spending money).

It is not known whether Inbrija inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use Inbrija?

Use Inbrija exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Inbrija is for use only in people who are currently taking carbidopa and levodopa. Do not stop taking your daily Parkinson’s medications or change your dosing schedule without your doctor’s advice.

For best results, use Inbrija when an “off episode” begins (when your Parkinson’s symptoms start to return). Do not use Inbrija more than 5 times per day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Inbrija is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load 2 capsules (one at a time) into the inhaler device each time you use the medicine. Pushing the handle of the device onto the mouthpiece will pierce the capsule and release the medicine into the inhaler.

Do not swallow a Inbrija capsule. It is for use only in the Inbrija inhaler device.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Inbrija.

Do not stop using Inbrija suddenly after long-term regular use, or you could have unpleasant withdrawal symptoms (fever, confusion, muscle stiffness, changes in breathing and heart rate). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you ready to load the inhaler device. Do not store capsules inside the device.

Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

84 mg via oral inhalation as needed when OFF period starts to return; may dose up to 5 times a day
Maximum dose per OFF period: 84 mg
Maximum daily dose: 420 mg

Comments:
-Therapy should be taken when symptoms of an OFF period start to return.
-This drug has shown efficacy only in combination with levodopa/carbidopa therapy.
-Oral inhalation capsules should only be used with the Inbrija(R) inhaler; capsules should not be swallowed whole as the intended effect will not be obtained.

Use: For the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

What happens if I miss a dose?

Since Inbrija is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include muscle pain or weakness, fever, dark colored urine, little or no urination, fast heartbeats, or fainting.

What should I avoid while using Inbrija?

Avoid driving or hazardous activity until you know how Inbrija will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Inbrija side effects

Get emergency medical help if you have signs of an allergic reaction to Inbrija: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Inbrija and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling this medicine.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and a light-headed feeling (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, paranoia, hallucinations (seeing or hearing things that are not real);
• unusual thoughts or behavior;
• trouble sleeping, or increased dreaming;
• agitation, aggression; or
• increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with Inbrija. Tell your doctor if you have any problems with daytime drowsiness.

Common Inbrija side effects may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea; or
• sweat, urine, or saliva that appears dark in color.

What is indapamide?

Indapamide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Indapamide treats fluid retention (edema) in people with congestive heart failure. indapamide is also used to treat high blood pressure (hypertension).

Indapamide may also be used for purposes not listed in this medication guide.

Indapamide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have signs of an electrolyte imbalance, such as:

• drowsiness, lack of energy, feeling tired;
• leg cramps, muscle weakness or limp feeling;
• severe weakness, loss of coordination, feeling unsteady;
• fast or irregular heartbeats, fluttering in your chest, feeling restless;
• numbness or tingling;
• vomiting, constipation;
• headache, confusion, slurred speech;
• a light-headed feeling, like you might pass out;
• dry mouth, increased thirst; or
• little or no urinating.

Common side effects of indapamide may include:

• dizziness;
• weakness, tiredness;
• back pain, muscle cramps;
• feeling anxious or agitated;
• headache; or
• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use indapamide if you are allergic to sulfa drugs or if you are unable to urinate.

Before taking this medicine

You should not use indapamide if you are allergic to it, or if:

• you are unable to urinate; or
• you are allergic to sulfa drugs.

To make sure indapamide is safe for you, tell your doctor if you have:

• cirrhosis or other liver disease;
• kidney disease;
• low levels of potassium or sodium in your blood;
• gout;
• diabetes;
• lupus; or
• if you are on a low-salt diet.

Indapamide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether indapamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Indapamide is not approved for use by anyone younger than 18 years old.

How should I take indapamide?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use indapamide in larger or smaller amounts or for longer than recommended.

Indapamide is usually taken once per day in the morning. Follow your doctor’s dosing instructions very carefully.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.

While using indapamide, you may need frequent medical tests and blood pressure checks. Your blood and urine may both be tested if you have been vomiting or are dehydrated.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Indapamide dosing information

Usual Adult Dose for Edema:

Initial dose: 2.5 mg orally once a day.

Usual Adult Dose for Hypertension:

Initial dose: 1.25 mg orally once a day.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include vomiting, weakness, dizziness, dry mouth, thirst, and muscle pain or weakness.

What should I avoid while taking indapamide?

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What is Inderal?

Inderal is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Inderal is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions. It is also used to treat or prevent heart attack, and to reduce the severity and frequency of migraine headaches.

Inderal LA are long-acting sustained-release capsules taken once daily. For angina treatment the dose can be gradually increased to three-to-seven-day intervals.

Inderal XL is supplied as an extended release capsule and is used for the treatment of hypertension. Inderal XL is taken once daily at bedtime.

Warnings

You should not use Inderal if you have asthma, very slow heart beats, or a serious heart condition such as “sick sinus syndrome” or “AV block” (unless you have a pacemaker).

Propranolol may mask the symptoms of hypoglycemia in diabetic patients. Report any changes in blood sugar levels to you doctor.

Use Inderal only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use Inderal if you are allergic to propranolol, or if you have:

• asthma;
• history of slow heart beats that have caused you to faint;
• severe heart failure (that required you to be in the hospital); or
• a serious heart condition such as “sick sinus syndrome” or heart block (2nd or 3rd degree, unless you have a pacemaker).

To make sure Inderal is safe for you, tell your doctor if you have ever had:

• slow heartbeats, congestive heart failure;
• bronchitis, emphysema, or other breathing disorders;
• diabetes (propranolol can make it harder for you to tell when you have low blood sugar);
• liver or kidney disease;
• a thyroid disorder;
• pheochromocytoma (tumor of the adrenal gland);
• problems with circulation (such as Raynaud’s syndrome); or
• if you smoke.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Inderal?

Take Inderal exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Adults may take Inderal with or without food, but take it the same way each time.

Doses are based on weight in children. Your child’s dose may change if the child gains or loses weight.

Your heart function and blood pressure will need to be checked often.

Tell your doctor if you have a planned surgery.

Your condition may get worse if you stop using Inderal suddenly. Ask your doctor before stopping the medicine.

Propranolol can affect the results of certain medical tests. Tell any doctor who treats you that you are using Inderal.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling light-headed or restless, tremors, fast or slow heartbeats, and trouble breathing.

What should I avoid while taking Inderal?

Avoid drinking alcohol. It may increase your blood levels of propranolol.

Propranolol side effects

Get emergency medical help if you have signs of an allergic reaction to Inderal (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• slow or uneven heartbeats;
• a light-headed feeling, like you might pass out;
• wheezing or trouble breathing;
• sudden weakness, vision problems, or loss of coordination;
• cold feeling in your hands and feet;
• depression, confusion, hallucinations;
• heart failure symptoms – swelling, rapid weight gain, feeling short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• low blood sugar in a baby – pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness.

Common Inderal side effects may include:

• dizziness, tiredness;
• nausea, vomiting, diarrhea, constipation, stomach cramps;
• sleep problems (insomnia); or
• runny or stuffy nose, cough, sore throat, hoarse voice.

What is indomethacin?

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that is used in adults and children at least 14 years old to treat signs and symptoms caused by certain types of arthritis such as moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis.

Indomethacin is also used to treat shoulder pain caused by bursitis or tendonitis.

Extended-release indomethacin should not be used to treat gouty arthritis.

Indomethacin may also be used for purposes not listed in this medication guide.

Indomethacin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using indomethacin and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Indomethacin may cause serious side effects. Stop using indomethacin and call your doctor at once if you have:

• a skin rash, no matter how mild;
• changes in your vision;
• flu-like symptoms;
• neurological problems–tremors or shaking, seizures, new or worsening depression, confusion, or psychosis, drowsiness;
• high blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• kidney or heart problems–swelling, urinating less, rapid weight gain, feeling tired or short of breath;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• low red blood cells (anemia)–pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Indomethacin may also worsen asthma attacks in people who have asthma. Talk with your doctor about your own risk.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of indomethacin may include:

• headache; dizziness;
• heartburn, stomach pain, gas; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Indomethacin can increase your risk of fatal heart attack or stroke. Do not use indomethacin just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Indomethacin may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Indomethacin can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

You should not use indomethacin if you are allergic to it, or if you have ever had an asthma attack, hives or a severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have or have ever had:

• congestive heart failure, heart disease, high blood pressure, high cholesterol, diabetes, smoking;
• a heart attack, stroke, or blood clot;
• bleeding problems;
• stomach ulcers or bleeding;
• depression, mood changes;
• seizures, epilepsy, Parkinson’s disease;
• asthma;
• fluid retention; or
• liver or kidney disease.

It may be harder for you to get pregnant while you are using this medicine.

Do not use indomethacin during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take indomethacin?

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Your dose needs may change if you switch to a different brand, strength, or form of indomethacin. Avoid medication errors by using only the form and strength your doctor prescribes.

Take this medicine with food or milk if it upsets your stomach.

You may be given other medications to help prevent certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

You may need medical tests to check your heart and kidney function. Your blood pressure will need to be checked often.

Tell your doctor if you have a planned surgery.

Call your doctor if your symptoms do not improve, or if they get worse. Indomethacin is not meant to be used long-term.

This medicine may affect the results of certain medical tests. Tell any doctor who treats you that you are using indomethacin.

Store at room temperature away from moisture and heat. Store the liquid medicine tightly closed away from light. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking indomethacin?

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Avoid smoking and drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to indomethacin (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Avoid driving or hazardous activity until you know how indomethacin will affect you. Your reactions could be impaired.

What other drugs will affect indomethacin?

Ask your doctor before using indomethacin if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Indomethacin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, pain, or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• aspirin;
• probenecid;
• a blood thinner–warfarin, Coumadin, Jantoven;
• medicine used to prevent blood clots–alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• steroid medicine (such as prednisone).

What is Infed?

Infed is used to treat iron deficiencies and iron deficiency anemia (low red blood cells).

Infed may also be used for purposes not listed in this medication guide.

Infed side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Infed can cause severe and sometimes fatal allergic reactions or severely low blood pressure. Call your doctor or seek medical help right away if you feel light-headed or if you suddenly have trouble breathing.

Also all your doctor at once if you have:

• fast or slow heartbeats. chest pain, wheezing, trouble breathing;
• a light-headed feeling, like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• blue-colored lips or fingernails;
• red or pink urine;
• weak or shallow breathing (breathing may stop);
• seizure (convulsions);
• swelling, warmth, redness, or itching where the medicine was injected; or
• delayed effect (1-2 days after injection)–fever, chills, dizziness, headache, general ill feeling, nausea and vomiting, joint or muscle pain, back pain.

Common side effects of Infed may include:

• mild itching or rash;
• body aches, numbness or tingly feeling;
• nausea, vomiting, stomach pain, diarrhea;
• mild dizziness or weakness, low fever; or
• brown discoloration of your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use Infed if you have a type of anemia that is not caused by iron deficiency.

Infed can cause severe and sometimes fatal allergic reactions or severely low blood pressure. Tell your caregiver right away if you feel light-headed (like you might pass out), or if you suddenly have trouble breathing.

Before taking this medicine

You should not receive Infed if you are allergic to it, or if you have a type of anemia that is not caused by iron deficiency.

Tell your doctor if you have ever had:

• heart disease;
• liver disease;
• kidney disease (or if you are on dialysis);
• rheumatoid arthritis;
• bleeding or blood clotting disorder such as hemophilia;
• stomach bleeding;
• asthma or allergies;
• if you are allergic to any medication; or
• if you use a beta-blocker medicine (atenolol, carvedilol, metoprolol, nebivolol, propranolol, sotalol, and others).

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Infed can cause injury to the unborn baby if you take the medicine during your second or third trimester.

It may not be safe to breastfeed while using Infed. Ask your doctor about any risk.

How is Infed given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Infed is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Infed must be given slowly. Injecting this medicine too quickly can cause serious side effects.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Tell your doctor if you have any changes in height or weight. Infed doses are based on these measures.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Infed.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include joint pain, chills, dizziness, fever, headache, muscle aches, nausea, and vomiting.

What should I avoid while using Infed?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What is Inflectra?

Inflectra (infliximab-dyyb) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.

Inflectra is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar to it and are designed to have the same effect, but they are not identical.

Inflectra works in the same way as the other versions of infliximab, by blocking the damage that results from too much tumor necrosis factor-alpha (TNF-alpha). Inflectra binds to TNF-alpha, which stops it from interacting with its receptors and certain activating processes.

TNF-alpha is a protein and inflammatory cytokine which plays a key role in your normal immune response. It is involved in your inflammatory response and also helps to fight off infection and cancer. Some people, however, produce too much TNF-alpha and this can cause an autoimmune disease to develop.

Inflectra was approved by the US Food and Drug Administration (FDA) in 2016, 18 years after the original version of infliximab was introduced. It was the first biosimilar of Remicade to be approved.

What is Inflectra used for?

Inflectra is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
• Ankylosing Spondylitis in adults
• Psoriatic Arthritis in adults
• Plaque Psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
• Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

It is not known if Inflectra is safe and effective in children under 6 years of age.

Important information

Inflectra may cause serious side effects, including:

1. Risk of infection

Inflectra is a medicine that affects your immune system. Inflectra can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Inflectra. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting Inflectra.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Inflectra.

Before starting Inflectra, tell your doctor if you:

• think you have an infection. You should not start receiving Inflectra if you have any kind of infection.
• are being treated for an infection.
• have signs of an infection, such as a fever, cough, flu-like symptoms.
• have any open cuts or sores on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive Inflectra. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B.
• use the medicines Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics used to treat the same conditions as Inflectra.

After starting Inflectra, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Inflectra can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using TNF-blocker medicines, such as Inflectra.
• For children and adults receiving TNF-blocker medicines, including Inflectra, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF-blockers, including Inflectra, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products, such as Inflectra, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Inflectra, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Inflectra.
• Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Inflectra, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

See the section “What are the possible side effects of Inflectra?” below for more information.

Who should not receive Inflectra?

You should not receive Inflectra if you have:

• heart failure, unless your doctor has examined you and decided that you are able to receive Inflectra. Talk to your doctor about your heart failure.
• had an allergic reaction to infliximab products, or any of the other ingredients in Inflectra. See below for a complete list of ingredients in Inflectra.

What should I tell my doctor before receiving Inflectra?

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you:

• have an infection (see “Important information” above).
• have other liver problems including liver failure.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you take Inflectra.
• have or have had any type of cancer.
• have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Inflectra.
• have COPD. Patients with COPD may have an increased risk of getting cancer while receiving Inflectra.
• have or have had a condition that affects your nervous system such as:
  • multiple sclerosis, or Guillain-Barré syndrome, or
  • if you experience any numbness or tingling, or
  • if you have had a seizure.
• have recently received or are scheduled to receive a vaccine. Adults and children receiving Inflectra should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Children should have all of their vaccines brought up to date before starting treatment with Inflectra.

How should I receive Inflectra?

• You will be given Inflectra through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Your doctor may decide to give you medicine before starting the Inflectra infusion to prevent or lessen side effects.
• Only a healthcare professional should prepare the medicine and administer it to you.
• Inflectra will be given to you over a period of about 2 hours.
• If you have side effects, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
• A healthcare professional will monitor you during the infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Inflectra to monitor you for side effects and to see how well you respond to the treatment.
• Your doctor will determine the right dose for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.

What should I avoid while receiving Inflectra?

Do not take Inflectra together with medicines such as Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics that are used to treat the same conditions as this medication.

Dosing information

Inflectra is administered by intravenous infusion for at least 2 hours.

• Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
• Pediatric Crohn’s Disease (≥ 6 years old)
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Pediatric Ulcerative Colitis (≥ 6 years old)
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Rheumatoid Arthritis
  • In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
• Ankylosing Spondylitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
• Psoriatic Arthritis and Plaque Psoriasis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

What are the side effects of Inflectra?

Serious side effects of Inflectra include:

• See “Important information” above.
• Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Inflectra. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Inflectra your doctor will treat your infection and may need to stop your Inflectra treatment.
  • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Inflectra:
    • a fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Inflectra and during treatment with Inflectra.
  • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Inflectra. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
  • If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Inflectra. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Inflectra and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
    • feel unwell
    • tiredness (fatigue)
    • poor appetite
    • fever, skin rash, or joint pain
• Heart Failure
  If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Inflectra. Your congestive heart failure may get worse while you are receiving Inflectra. Be sure to tell your doctor of any new or worse symptoms including:
  • shortness of breath
  • swelling of ankles or feet
  • sudden weight gain
    Treatment with Inflectra may need to be stopped if you get new or worse congestive heart failure.
• Other Heart Problems
  Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of an infliximab product. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
• Liver Injury
  Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
  • jaundice (skin and eyes turning yellow)
  • dark brown-colored urine
  • pain on the right side of your stomach area (right-sided abdominal pain)
  • fever
  • extreme tiredness (severe fatigue)
• Blood Problems
  In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
  • have a fever that does not go away
  • bruise or bleed very easily
  • look very pale
• Nervous System Disorders
  Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
  • changes in your vision
  • numbness or tingling in any part of your body
  • weakness in your arms or legs
  • seizures
    Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
• Allergic Reactions
  Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Inflectra treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Inflectra and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
  • hives (red, raised, itchy patches of skin)
  • difficulty breathing
  • chest pain
  • high or low blood pressure
  • fever
  • chills
    Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Inflectra:
    • fever
    • rash
    • headache
    • sore throat
    • muscle or joint pain
    • swelling of the face and hands
    • difficulty swallowing
• Lupus-like Syndrome
  Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Inflectra.
  • chest discomfort or pain that does not go away
  • shortness of breath
  • joint pain
  • rash on the cheeks or arms that gets worse in the sun
• Psoriasis
  Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Inflectra.

The most common side effects of infliximab products include:

• respiratory infections, such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Inflectra. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

Children with Crohn’s disease showed some differences in side effects of treatment compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Inflectra. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Inflectra harms your unborn baby. Inflectra should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Inflectra if you are pregnant or plan to become pregnant.

If you have a baby and you were receiving Inflectra during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Inflectra use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Inflectra while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive Inflectra while breastfeeding.

Storage

Store unopened Inflectra vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

Do not use Inflectra beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.

What are the ingredients in Inflectra?

Active ingredient: infliximab-dyyb.

Inactive ingredients: : dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Inflectra is manufactured by Celltrion, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea and distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017

Inflectra Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Inflectra.Remicade (infliximab) – Janssen Biotech, Inc.

What is Inrebic?

Inrebic is used to reduce symptoms of myelofibrosis (MF) in adults, such as night sweats, itching, pain, and feeling full when eating, and it also helps reduce spleen volume. Myelofibrosis is a rare type of bone marrow disorder.

Inrebic’s mechanism of action involves blocking certain types of enzymes called kinases that are overactive in myelofibrosis, such as Janus-associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). These enzymes are involved in signaling pathways that contribute to excessive inflammation in bone marrow, an enlarged spleen, and symptoms of myelofibrosis. Inrebic (fedratinib) belongs to the drug class called kinase inhibitors.

Inrebic gained FDA approval on August 16, 2019. There is no Inrebic generic.

Inrebic uses

Inrebic is used to treat intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis in adults.

Inrebic side effects

The most common side effects of Inrebic are:

• diarrhea
• nausea
• low red blood cell count (anemia)
• vomiting.

Serious side effects and warnings

Inrebic carries a Boxed Warning for encephalopathy, including Wernicke’s encephalopathy.

Encephalopathy (including Wernicke’s encephalopathy). A serious and sometimes fatal neurological problem called encephalopathy (including Wernicke’s encephalopathy) has happened in some people who take Inrebic. Wernicke’s encephalopathy is a neurologic emergency that can happen if you do not have enough Vitamin B1 (thiamine) in your body. Your healthcare provider will do a blood test to check your Vitamin B1 level and treat you with Vitamin B1 if your level is too low before starting treatment with Inrebic. Your healthcare provider may also check your Vitamin B1 level during treatment and you should take a Vitamin B1 supplement (100 mg of thiamine) throughout treatment with Inrebic. Get emergency medical help right away if you develop the following:

• confusion, memory problems, or drowsiness
• problems with balance and movement, such as difficulty walking
• eye problems, such as double or blurred vision or abnormal eye movements

Call your healthcare provider right away if you experience diarrhea, nausea, vomiting, and weight loss that does not get better with treatment.

Low blood cell counts. Inrebic may cause new or worsening low red blood cell counts (anemia) and low platelet counts (thrombocytopenia) in some people. You may need a blood transfusion if your blood counts drop too low. Your healthcare provider will do blood tests to check your blood counts before you start and during treatment with Inrebic. Tell your healthcare provider if you develop any bleeding or bruising during treatment with Inrebic.

Diarrhea, nausea, and vomiting. Your healthcare provider may give you certain medicines to help treat diarrhea, nausea, and vomiting caused by Inrebic. Call your healthcare provider or get emergency medical help right away if you have diarrhea, nausea, or vomiting that does not get better with treatment.

Liver problems. Inrebic may cause increased liver enzymes. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with Inrebic.

Amylase and lipase increases. You may have increases in your blood amylase or lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your amylase or lipase levels before starting and during treatment with Inrebic.

Major cardiac events such as heart attack, stroke, or death. An increased risk of major cardiac events has happened in people, especially those who have cardiovascular risk factors and who are current or past smokers, while taking another Janus Kinase (JAK)-inhibitor to treat rheumatoid arthritis. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Inrebic, including:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech.

Blood clots. Increased risk of blood clots in the veins of the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Inrebic, including:

• swelling, pain, or tenderness in one or both legs
• sudden unexplained chest or upper back pain
• shortness of breath or difficulty breathing.

New (secondary) cancers. People who take another JAK-inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers, except nonmelanoma skin cancer. People who smoke or who smoked in the past have an increased risk of new cancers.

Inrebic may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Inrebic: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Driving and using machines: While using this medicine, you may feel weak, tired, dizzy, or confused. You may have blurred vision. Before driving a vehicle or using machinery, wait to see how you feel after taking Inrebic.

Call your doctor at once if you have:

• severe or ongoing nausea, vomiting, or diarrhea (even while you are taking medication to prevent these effects);
• easy bruising, unusual bleeding, purple or red spots under your skin;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

You may need a blood transfusion if your blood counts get too low.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

To make sure Inrebic is safe for you, tell your doctor if you:

• have low vitamin B1 (thiamine) levels
• have low red blood cell or platelet counts
• have or have had liver problems
• have or have had kidney problems
• are a current or past smoker
• have had a blood clot, heart attack, other heart problems, or stroke
• have or have had any other cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Inrebic is not for use in patients under the age of 18 years.

Pregnancy

It is not known if Inrebic may harm your unborn baby.

Breastfeeding

It is not known if Inrebic passes into your breast milk. You should not breastfeed during treatment with Inrebic and for at least 1 month after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment.

How should I take Inrebic?

Take Inrebic exactly as prescribed by your doctor. Follow all directions on your Inrebic Package Insert and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

• Inrebic is taken 1 time a day.
• You may take Inrebic capsules with or without food. Taking Inrebic with a high-fat meal may help to reduce nausea and vomiting symptoms.
• Take Vitamin B1 (thiamine 100 mg) by mouth daily to prevent low Vitamin B1 levels during treatment with Inrebic.

You may be given other medications to help prevent nausea, vomiting, and diarrhea. Keep using these medicines for as long as your doctor has prescribed.

Call your doctor if you are sick with vomiting or diarrhea even while taking medications to prevent these side effects. You can easily become malnourished from vomiting and diarrhea. This can lead to low vitamin B1 levels.

Inrebic can lower your blood cell counts and affect liver function. Your blood will need to be tested often. Your treatments may be delayed based on the results.

Do not change your dose or stop taking Inrebic without your doctor’s advice.

Inrebic dosing

Usual Adult Dose of Inrebic for Myelofibrosis: Inrebic 400 mg orally once a day for patients with a baseline platelet count of 50 x 10⁹/L or greater

Management of thiamine levels and Wernicke’s encephalopathy (WE):

• Assess thiamine levels and nutritional status before starting therapy, periodically during therapy, and as indicated.
• Do not initiate this drug in patients with thiamine deficiency; replete thiamine before therapy initiation and during therapy if thiamine levels are low.
• If Wernicke’s encephalopathy is suspected, immediately discontinue therapy and initiate parenteral thiamine treatment.
• Monitor until symptoms resolve or improve and thiamine levels normalize.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Inrebic may make you feel drowsy or dizzy and make it difficult for you to operate machinery or to drive. Do not drive or operate machinery or perform other hazardous tasks if Inrebic affects you in this way.

What is insulin aspart?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Insulin aspart is used to improve blood sugar control in adults and children with diabetes mellitus. insulin aspart is sometimes used together with a long-acting or intermediate-acting insulin.

Insulin aspart may also be used for purposes not listed in this medication guide.

Insulin aspart side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Insulin aspart may cause serious side effects. Call your doctor at once if you have:

• heart problems–swelling, rapid weight gain, feeling short of breath; or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of insulin aspart may include:

• low blood sugar;
• weight gain;
• low potassium;
• swelling in your hands and feet;
• skin rash, itching, redness, or swelling; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use insulin aspart if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin aspart is not approved for use by anyone younger than 2 years old, and should not be used to treat type 2 diabetes in a child of any age. Fiasp is for use only in adults.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin aspart?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Insulin aspart is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Your healthcare provider will show you where on your body to inject insulin aspart. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject insulin aspart into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Novolog, you should eat a meal within 5 to 10 minutes. Fiasp should be given at the start of a meal or within 20 minutes after starting a meal.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. This medicine should be clear and colorless. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

If you use an injection pen, use only the pen provided with your medicine. If you use this medicine with an insulin pump, do not mix or dilute insulin aspart with any other insulin. Change the medicine in the reservoir at least every 6 days.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin aspart is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin aspart:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) insulin aspart:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Since insulin aspart is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin aspart, be sure to eat a meal within 5 to 10 minutes. Do not use extra insulin aspart to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin aspart?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how insulin aspart will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. Alcohol can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect insulin aspart?

Insulin may not work as well when you use other medicines at the same time. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

Insulin aspart Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin aspart.Fiasp (insulin aspart) – Novo Nordisk Inc.

What is insulin degludec?

Insulin degludec is a long-acting basal human insulin analog that is used to improve glycemic control in people with diabetes.

Insulin is a hormone produced by your body that helps you to lower your blood glucose (blood sugar) levels.

People with type 1 diabetes and some people with type 2 diabetes need to administer man-made forms of insulin. This is because they don’t produce enough insulin themselves or their body doesn’t respond well enough to the insulin they produce.

Basal insulin analogs like insulin degludec, work to keep your blood glucose levels stable during times when you’re fasting, such as at night when you’re asleep. Insulin degludec provides a ‘background’, slow-acting supply of insulin.

Insulin degludec was approved by the US Food and Drug Administration (FDA) in 2015. The Tresiba brand of insulin degludec is the only version of this medication currently available.

What is insulin degludec used for?

• Insulin degludec is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus.
• Insulin degludec is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• It is not known if insulin degludec is safe and effective in children under 1 year of age.
• Insulin degludec is available in 2 concentrations (U-100 and U-200):
  • U-100 concentration is available in pen and vial
    • The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in increments of 1 unit.
    • The 100 units/mL vial should be used with a U-100 insulin syringe only.
  • U-200 concentration is only available in pen
    • The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in increments of 2 units.

Important information

Do not share your insulin degludec FlexTouch insulin delivery device (pen) with other people, even if the needle has changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.

Who should not take insulin degludec?

Do not take insulin degludec if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin degludec or any of the ingredients in insulin degludec. See below for a complete list of ingredients.

What should I tell my doctor before taking insulin degludec?

Before taking insulin degludec, tell your healthcare provider about all your medical conditions including, if you are:

• pregnant, planning to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking insulin degludec, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take insulin degludec?

• Read the Instructions for Use that come with your insulin degludec.
• Take insulin degludec exactly as your healthcare provider tells you to.
• Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Both the 100 units/mL and 200 units/mL insulin degludec FlexTouch pens are made to deliver your insulin dose in units.
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• For children who need less than 5 units of insulin degludec each day, use a insulin degludec U-100 vial.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
• Never inject insulin degludec into a vein or muscle.
• Never use a syringe to remove insulin degludec from the FlexTouch pen.
• Insulin degludec can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What happens if I miss a dose?

• Adults: If you miss or are delayed in taking your dose of insulin degludec:
  • Take your dose as soon as you remember then continue with your regular dosing schedule.
  • Make sure there are at least 8 hours between your doses.
• If children miss a dose of insulin degludec:
  • Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of insulin degludec.

What should I avoid while taking insulin degludec?

While taking insulin degludec do not:

• Drive or operate heavy machinery, until you know how insulin degludec affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Dosing information

• Inject insulin degludec subcutaneously into the thigh, upper arm, or abdomen.
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• For pediatric patients requiring less than 5 units of insulin degludec each day, use a U-100 vial.
• In adults, inject subcutaneously once daily at any time of day.
• In pediatric patients inject subcutaneously once daily at the same time every day.
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal.
• The recommended days between dose increases are 3 to 4 days.

Starting dose in patients who are not taking insulin:

• Type 1 diabetes
  The recommended starting dose of insulin degludec in insulin naive patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naive patients with type 1 diabetes.
• Type 2 diabetes
  The recommended starting dose of insulin degludec in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

Starting dose in patients already taking insulin:

• Adults with type 1 or type 2 diabetes
  Start insulin degludec at the same unit dose as the total daily long or intermediate-acting insulin unit dose.
• Pediatric patients (≥ 1 year of age) with type 1 or type 2 diabetes
  Start insulin degludec at 80 percent of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia

See full prescribing information for additional important information about insulin degludec dosing.

What are the side effects of insulin degludec?

Insulin degludec may cause serious side effects that can lead to death, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness
  • blurred vision
  • anxiety, irritability, or mood changes
  • sweating
  • slurred speech
  • hunger
  • confusion
  • shakiness
  • headache
  • fast heartbeat
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with insulin degludec may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with insulin degludec. Your healthcare provider should monitor you closely while you are taking TZDs with insulin degludec. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and insulin degludec may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Your insulin dose may need to change because of:

• change in level of physical activity or exercise
• weight gain or loss
• increased stress
• illness
• change in diet

Common side effects of insulin degludec may include:

• serious allergic reactions (whole body reactions)
• reactions at the injection site
• skin thickening or pits at the injection site (lipodystrophy)
• itching
• rash
• swelling of your hands and feet
• weight gain

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• swelling of your face, tongue, or throat
• sweating
• extreme drowsiness
• dizziness
• confusion

These are not all the possible side effects of insulin degludec. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medications that may:

• increase your risk of hypoglycemia (low blood sugar)
• increase or decrease how well insulin degludec works
• make it hard to tell if your blood sugar is getting too low

Ask your healthcare provider or pharmacist if you are not sure if you take one of these medications.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. There is a risk to mother and fetus associated with poorly controlled diabetes in pregnancy. However, there is a lack of data available to determine whether insulin degludec is safe in pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. There is a lack of data available to determine whether insulin degludec is safe to use while breastfeeding. Talk to your doctor about whether the benefits of taking insulin degludec while breastfeeding outweigh any possible risks. Talk to your doctor about the best way to feed your baby while taking insulin degludec.

Storage

Vials before use:

• Store unopened insulin degludec vials in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze insulin degludec. Do not use insulin degludec if it has been frozen.
• Unused insulin degludec vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
• After 56 days, throw away insulin degludec vials that have been kept at room temperature (below 86°F (30°C)).

Vials in use:

• Store the insulin degludec vial you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature below 86°F (30°C) in the original carton to protect from light.
• Keep insulin degludec away from direct heat or light.
• The insulin degludec vial you are using should be thrown away after 56 days, even if it still has insulin left in it and the expiration date has not passed.

Pen before use:

• Store unused insulin degludec FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze insulin degludec. Do not use insulin degludec if it has been frozen.
• Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.

Pen in use:

• Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature below 86°F (30°C).
• Keep insulin degludec away from heat or light.
• The insulin degludec FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.

What are the ingredients in insulin degludec?

Active Ingredient: insulin degludec

Inactive Ingredients: glycerol, metacresol, phenol, water for injection, and zinc. Hydrochloric acid or sodium hydroxide may be added.

Insulin degludec is manufactured under the brand name Tresiba by Novo Nordisk A/S, DK-2880 Bagsværd, Denmark.

Insulin degludec Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin degludec.Tresiba (insulin degludec) – Novo Nordisk Inc.

V

What is insulin detemir?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin detemir is a man-made long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Insulin detemir is used to improve blood sugar control in people with diabetes mellitus.

Insulin detemir is for use in adults and children at least 2 years old.

Insulin detemir is not to be used to treat diabetic ketoacidosis.

Warnings

Never share an injection pen or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use insulin detemir if you are allergic to it. Do not use during an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

To make sure insulin detemir is safe for you, tell your doctor if you have ever had:

• low levels of potassium in your blood (hypokalemia); or
• liver or kidney disease.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin detemir may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin detemir if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin detemir?

Use insulin detemir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Insulin detemir is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an insulin detemir injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject insulin detemir. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject insulin detemir into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

If you use insulin detemir once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.

Your doctor may want you to also use a short-acting insulin. Always inject your insulins separately. Insulin detemir must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

If you use an injection pen, use only the injection pen that comes with insulin detemir. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin detemir is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep insulin detemir in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin detemir:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 42 days.

Storing opened (in use) insulin detemir:

• Store the vial in a refrigerator or at room temperature and use within 42 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 42 days. Do not store the injection pen with a needle attached.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin detemir?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how insulin detemir will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol.

Insulin detemir side effects

Get emergency medical help if you have signs of an allergy to insulin detemir: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common insulin detemir side effects may include:

• low blood sugar;
• weight gain;
• swelling in your hands and feet;
• rash, itching; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect insulin detemir?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Insulin detemir Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin detemir.Levemir (insulin detemir) – Novo Nordisk Inc.

What is insulin glargine?

Insulin glargine is a long-acting insulin used to treat type 1 and type 2 diabetes in certain patients to improve and maintain blood glucose levels. Insulin glargine is a man-made form of human insulin that is used once daily to provide a base level of insulin that keeps working for 24 hours or longer.

Insulin glargine is available under the brand names Lantus, Basaglar, Toujeo, Semglee, and Rezvoglar.

Rezvoglar, Lantus, Semglee, and Toujeo are FDA-approved to be used for use in adult and pediatric patients with type 1 and type 2 diabetes. Basasglar is FDA-approved to be used by adults for type 2 diabetes and also for adults and pediatric patients with type 1 diabetes. In patients with type 1 diabetes, insulin glargine must be used together with a short-acting insulin.

Insulin glargine side effects

Common insulin glargine side effects may include low blood sugar, swelling, weight gain, allergic reaction, itching, rash, or thickening or hollowing of the skin where you injected the medicine (lipodystrophy).

Serious insulin glargine side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Insulin glargine may cause other serious side effects. Call your doctor at once if you have:

• rapid weight gain, swelling in your feet or ankles;
• shortness of breath; or
• low blood potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Never share an injection pen, even if you changed the needle.

Before taking this medicine

You should not use insulin glargine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Different brands of insulin glargine are specifically approved for different age groups and different diabetes types. The safety and effectiveness of insulin glargine in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant, as it is not known if insulin glargine will harm your unborn baby. Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or are planning to breastfeed, as it is not known if insulin glargine may harm your breastfeeding baby.

How should I use insulin glargine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed colors, or has particles in it.

Insulin glargine is injected under the skin, using a syringe or insulin pen, once per day at the same time of day.

Insulin can be injected into your upper legs (thighs), upper arms, or stomach area (abdomen). Do not inject into the same place two times in a row. Avoid injecting into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

When treating type 1 diabetes, use your short-acting insulin before meals as directed by your doctor.

Insulin glargine must not be given with an insulin pump or mixed with other insulins. Do not inject insulin glargine into a vein or a muscle.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

If you use an injection pen, use only the injection pen that comes with insulin glargine. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen, even if you changed the needle. Sharing these devices can pass infections from person to person.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injections in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia), such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Wear a medical alert tag or carry an ID card to let others know you have diabetes.

Insulin glargine is available as:

Basaglar 100 units/mL is available as Basaglar KwikPen 3 mL, BasaglarTempo Pen

3 mL

Lantus 100 units/mL is available as a Lantus multiple-dose vial 10 mL, Lantus SoloStar prefilled pen 3 mL

Rezvoglar 100 units/mL available as Rezvoglar KwikPen prefilled pen 3 mL

Semglee 100 units/mL available as Semglee multiple-dose vial 10 mL, Semgleeprefilled pen 3 mL

Toujeo 300 units/mL available as Toujeo SoloStar prefilled pen 1.5 ml, Toujeo Max SoloStar 3 mL prefilled pen

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause severe hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin glargine?

Avoid driving or hazardous activity until you know how insulin glargine will affect you. Your reactions could be impaired.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

What other drugs will affect insulin glargine?

Many drugs can affect your blood sugar and may also affect insulin glargine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Not all possible interactions are listed here.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Storage

Storing unopened (not in use) insulin glargine:

• Refrigerate at 36°F–46°F (2°C–8°C )
• Do NOT use after the expiration date.

Storing opened (in use) insulin glargine:

• Storage once in use varies for different brands of insulin glargine. For storage information for the different brands of insulin glargine while in use, check prescribing information.

General storage information

• Keep this medicine in its original container protected from heat and light.
• Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Company

Basaglar manufactured by: Eli Lilly and Company, Indianapolis, IN 46285 USA.

Lantus manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY.

Rezvoglar manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA.

Semglee manufactured by: Biocon Biologics Inc. 245 Main St, 2nd Floor, Cambridge, MA 02142 USA.

Toujeo manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY.

Insulin glargine Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 4 for insulin glargine.Basaglar (insulin glargine) – Eli Lilly and Company