Jaypirca is a cancer medicine used to treat types of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Jaypirca tablets may help to reduce the amount of CLL, SLL, and MCL, and for MCL it may remove the cancer. It can help treat cancer in patients who have already been treated with ibrutinib, acalabrutinib, or zanubrutinib (covalent BTK inhibitors), as it works differently than these cancer medicines.

Jaypirca FDA approval was received on January 27, 2023, as an accelerated approval based on response rate. Continued approval for these indications may depend on verification and description of clinical benefit in other trials.

Jaypirca tablet is an oral kinase inhibitor, and more specifically, it is a non-covalent (reversible) BTK inhibitor.

How does Jaypirca work?

Jaypirca’s mechanism of action (MOA) is that it blocks BTK, which is a signaling protein found across numerous B-cell leukemia and lymphomas, including MCL, CLL, and SLL, that, when stimulated, activates pathways responsible for B-cell proliferation, activity, and growth. This blocks the activity that leads to the growth of the B-cells and causes cell death of the malignant B-cells. Jaypirca belongs to the class of drugs called Bruton’s tyrosine kinase (BTK) inhibitors and is highly selective for BTK (300 times more selective than most other kinases).

What is Jaypirca used for?

Jaypirca FDA approval is for adult patients with:

• Relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of treatment, including a BTK inhibitor
• Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two lines of treatment, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Jaypirca side effects

Common Jaypirca side effects

Common Jaypirca side effects may include bruising, tiredness, diarrhea, swelling, muscle, joint pain, bone pain, fever, chills, cough with mucus, chest pain, and feeling short of breath.

Serious Jaypirca side effects

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

Other serious Jaypirca side effects. Call your doctor at once if you have:

• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• bleeding inside your body – weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• 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.

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

Also, see the Warnings section.

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. Serious and deadly infections caused by bacteria, viruses, or fungi have occurred with Jaypirca, 24% were Grade 3 or higher; opportunistic infections such as those caused by Pneumocystis jirovecci pneumonia also occurred. Consider prophylaxis, such as vaccinations and antibiotics in those at increased risk.

Bleeding. Serious and fatal bleeding events (hemorrhage) have also occurred with Jaypirca. Monitor for any signs of bleeding and manage appropriately.

Low blood cell counts. Lower than normal blood cell counts, including low neutrophils, platelets, or red blood cells, can occur. Your healthcare provider will monitor your blood counts regularly throughout treatment.

Liver problems which may be severe or life-threatening, or lead to death, can happen in people treated with Jaypirca. Your healthcare provider will do blood tests to check your liver before and during treatment. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes

Cardiac arrhythmia. Cardiac arrhythmias may occur, including atrial fibrillation and atrial flutter, and second primary cancers, including skin cancers, have also occurred. Use sun protection when outside.

Fetal Harm. This medicine can cause fetal harm. Females of reproductive potential should use effective contraception.

It is not known if this medicine is safe and effective in children.

Before taking this medicine

Tell your doctor if you have or have ever had:

• an infection or have been told you are at an increased risk of infection;
• recent surgery, or plan to have surgery or a dental procedure;
• bleeding problems or are taking a blood thinner medicine;
• heart rhythm problems;
• high blood pressure;
• other types of cancer, including skin cancer; or
• kidney disease.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant or become pregnant, as this medicine may harm an unborn baby. Do not use this medicine if you are pregnant. Your healthcare provider will do a pregnancy test before starting treatment in females who can become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after their last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Jaypirca passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose.

How should I take this medicine?

Jaypirca instructions

Take Jaypirca tablets 1 time each day at about the same time each day. Tablets can be taken with or without food. Tablets should be swallowed whole with water. Do not cut, crush, or chew the tablets.

General Information

Take Jaypirca tablets exactly as your healthcare provider tells you. Do not change your dose or stop treatment unless your healthcare provider tells you to do so.

You will need to have blood tests often.

Using this medicine may increase your risk of developing cancer. Ask your doctor about your individual risk.

Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Jaypirca Dosing Information

Usual Adult Dose of Jaypirca for CLL, SLL, and MCL
Dose: 200 mg orally once daily
Length of Therapy: Until disease progression or unacceptable toxicity occurs.
Comments: These indications are approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Use:

• For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
• For the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two lines of treatment, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Jaypirca is available in 50 mg and 100 mg tablets.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember on the same day. If it has been more than 12 hours from the time you usually take Jaypirca, skip the missed dose, and take your next dose on the next day at your usual time.

What other drugs will affect Jaypirca?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Jaypirca with certain other medicines may affect how Jaypirca or the other medicines work and can cause side effects.

Jaypirca interacts with other drugs that are metabolized in a certain way. Tell your doctor if you are taking medicines that contain any of the following drugs:

• strong CYP3A inhibitors: cobicistat, ritonavir, itraconazole, ketoconazole, posaconazole, voriconazole, ceritinib, clarithromycin, idelalisib, nefazodone, nelfinavir
• strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, ivosidenib, lumacaftor, mitotane, phenytoin, rifampin, St. John’s wort
• moderate CYP3A inducers: bosentan, cenobamate, dabrafenib, efavirenz, etravirine, lorlatinib, pexidartinib, phenobarbital, primidone, sotorasib

What is itraconazole?

Itraconazole is an antifungal medication that is used in adults to treat infections caused by fungus. This includes infections in any part of the body including the lungs, mouth or throat, toenails, or fingernails.

The Tolsura brand of itraconazole is not for use in treating fungal infections of the fingernails or toenails. Avoid medication errors by using only the brand and strength your doctor prescribes.

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

Itraconazole side effects

Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Keep taking itraconazole but call your doctor at once if you have:

• confusion, a light-headed feeling (like you might pass out);
• blurred vision, double vision, ringing in your ears, problems with hearing;
• fast heartbeats;
• numbness or tingly feeling, loss of bladder control;
• little or no urinating, pain or burning when you urinate;
• low potassium level–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling;
• pancreatitis–severe pain in your upper stomach spreading to your back, nausea and vomiting; or
• liver problems–nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of itraconazole may include:

• headache, dizziness, drowsiness, tiredness;
• increased blood pressure;
• rash, itching;
• nausea, vomiting, stomach pain, diarrhea, constipation;
• swelling;
• abnormal liver function or blood tests;
• fever, muscle or joint pain;
• unusual or unpleasant taste in your mouth;
• hair loss;
• impotence, erection problems; or
• changes in your menstrual periods.

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 take itraconazole if you have ever had heart failure.

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, or solifenacin.

Itraconazole may harm an unborn baby. Avoid getting pregnant while taking itraconazole and for 2 months after your last dose.

Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Life-threatening side effects may occur if you take itraconazole with certain other drugs. Tell your doctor about all your current medicines and any you start or stop using.

Before taking this medicine

You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

Life-threatening side effects may occur if you take itraconazole with certain other drugs. Your doctor may change your treatment plan if you have used other medicines in the past 2 weeks, especially:

• avanafil;
• cisapride;
• eliglustat;
• irinotecan;
• isavuconazonium;
• methadone;
• naloxegol;
• ranolazine;
• ticagrelor;
• lurasidone or pimozide (anti-psychotic medications);
• lomitapide, lovastatin, simvastatin (cholesterol-lowering medicines);
• dihydroergotamine, ergonovine, ergotamine, or methylergonovine (ergot medicines);
• eplerenone, felodipine, ivabradine, or nisoldipine (heart or blood pressure medicines);
• disopyramide, dofetilide, dronedarone, or quinidine (medicines for heart rhythm disorders); or
• oral midazolam, or triazolam (Valium-like sedatives).

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, solifenacin, or telithromycin.

Itraconazole may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• heart problems;
• cystic fibrosis or other lung problems;
• liver or kidney disease; or
• a weak immune system.

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

How should I take itraconazole?

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

Do not share itraconazole with another person, even if they have the same symptoms you have.

The itraconazole capsule should be taken with food.

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

Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Avoid medication errors by using only the form and strength your doctor prescribes.

If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take itraconazole with an acidic drink such as non-diet cola.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Itraconazole will not treat a viral infection such as the flu or a common cold.

You may need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

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 itraconazole?

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

Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.

What other drugs will affect itraconazole?

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

Many drugs can affect itraconazole, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 

What is ivabradine?

Ivabradine works by affecting your heart’s electrical activity in order to slow the heart rate.

Ivabradine is used in adults with chronic heart failure, to help lower the risk of needing to be hospitalized when symptoms get worse.

Ivabradine is also used in children at least 6 months old who have stable heart failure caused by an enlarged heart.

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

Ivabradine 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.

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

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• very slow heartbeats;
• severe headache, blurred vision, pounding in your neck or ears;
• racing heartbeats with dizziness, tiredness, or a lack of energy;
• chest tightness; or
• shortness of breath that is worse than usual.

If your baby is taking ivabradine, watch for symptoms of feeding problems, trouble breathing, or turning blue.

Ivabradine can cause a temporary brightness in your vision, especially during the first 2 months of treatment. This can make you see halos around lights, see colors within lights, or see multiple images while looking at an object. You may also see kaleidoscope colors or flashes of movement in certain parts of your vision. Sudden bright light can make these vision changes more noticeable. These effects usually go away as you continue taking ivabradine or after you stop taking it.

Common side effects of ivabradine may include:

• slow or irregular heartbeats;
• high blood pressure; or
• your eyes may be more sensitive to light.

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 ivabradine if you have severe liver disease, very low blood pressure, a slow resting heart rate, a serious heart condition such as “sick sinus syndrome” or 3rd-degree “AV block” (unless you have a pacemaker), or if you depend on a pacemaker to control your heart rate.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Ivabradine may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Ivabradine can cause serious heart rhythm problems. Call your doctor at once if you have chest pressure, racing or pounding heartbeats, very slow heartbeats, weakness, tiredness, severe dizziness, or shortness of breath that is worse than usual.

If your baby is taking ivabradine, watch for symptoms of feeding problems, trouble breathing, or turning blue.

Before taking this medicine

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

• a serious heart condition such as “sick sinus syndrome” or 3rd-degree “AV block” (unless you have a pacemaker);
• heart failure symptoms that recently got worse;
• very low blood pressure;
• a slow resting heart rate;
• severe liver disease; or
• if you depend on a pacemaker to control your heart rate.

Some medicines can cause unwanted or dangerous effects when used with ivabradine. Your doctor may need to change your treatment plan if you use any of the following drugs:

• an antibiotic or antifungal medicine;
• an antidepressant;
• antiviral medicine to treat hepatitis C or HIV/AIDS; or
• other heart medicine or blood pressure medication (such as amiodarone, digoxin, diltiazem, or verapamil).

Tell your doctor if you have any other heart problems not being treated with ivabradine.

Taking ivabradine during pregnancy may harm an unborn baby or lead to premature birth. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using ivabradine.

How should I take ivabradine?

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.

Ivabradine is usually taken 2 times per day with food. Avoid grapefruit or grapefruit juice.

Tell your doctor if you have trouble swallowing a ivabradine tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Each plastic ampule is for one use only. Throw it away after one use, even if there is still medicine left inside.

If a child taking ivabradine spits outs the medicine shortly after taking, do not give another dose. Wait until the next scheduled dose time to give the medicine again.

You may also need to take another medicine called a beta-blocker. Use all medications as directed and read all medication guides you receive. Do not stop taking your medication or change your doses without your doctor’s advice.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture, heat, and light. Keep the ampules of liquid ivabradine in the foil pouch and use the medicine right away after opening.

Ivabradine dosing information

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day with meals
Maximum dose: 7.5 mg orally twice a day

Comments:
-In patients with a history of conduction defects or in patients whom bradycardia could lead to hemodynamic compromise, start with 2.5 mg orally twice a day.
-Assess after 2 weeks and adjust dose to maintain tolerability and achieve resting heart rate between 50 and 60 beats per minute (bpm); if resting heart rate is greater than 60 bpm, increase by 2.5 mg twice daily to a maximum of 7.5 mg twice daily; if resting heart rate is less than 50 bpm or bradycardia signs and symptoms occur, decrease by 2.5 mg twice daily (discontinue if current dose is 2.5 mg orally twice a day).

Use: To reduce worsening heart failure hospitalization risk in patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) at or below 35%, who are in sinus rhythm with resting heart rate at or above 70 bpm and are either unable to tolerate or have a contraindication to beta-blockers.

Usual Pediatric Dose for Congestive Heart Failure:

6 Months or Older:
Less than 40 kg (oral solution):
-Initial dose: 0.05 mg/kg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 0.05 mg/kg to target a heart rate reduction of at least 20%, based on tolerability.
-Maximum dose: 6 months to less than 1 year old: 0.2 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day; 1 year or older: 0.3 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day.

40 kg or more (tablets):
-Initial dose: 2.5 mg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 2.5 mg to target a heart rate reduction of at least 20%, based on tolerability.
-Maximum dose: 7.5 mg orally twice a day

Use: Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients 6 months or older who are in sinus rhythm with an elevated heart rate.

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 should I avoid while taking ivabradine?

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

Avoid taking an herbal supplement containing St. John’s wort.

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

Avoid sudden changes in the intensity of light around you, such as going outside in sunlight after being in a dark place. Allow your eyes time to adjust slowly to the light.

What is ivermectin?

Ivermectin is an anti-parasite medication used to treat parasitic diseases. It is FDA approved for use in humans to treat a variety of parasitic infections including parasitic worms, hookworm and whipworm. Ivermectin may also be used as an effective treatment for a wide range of other conditions and as a treatment of onchocerciasis, intestinal strongyloidiasis and onchocerciasis or river blindness.

The antiviral activity of Ivermectin has been shown against a wide range of RNA and DNA viruses, for example, dengue, Zika, yellow fever, and others.

Ivermectin and Covid-19 Treatment

Ivermectin is currently being investigated in a clinical trial as a potential COVID-19 treatment for the coronavirus SARS-CoV-2 Virus, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 infection in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19 to reduce viral replication, except in clinical trials.

Experimental studies for ivermectin as an adjunct treatment for antiviral effects of hospitalized adult COVID-19 patients: a randomized multi-center clinical trial. There is currently insufficient evidence from the COVID-19 Treatment Guidelines Panel to recommend either for or against the use of ivermectin in Covid-19 patients for the treatment of severe or mild COVID-19 symptoms.

Click for further information on using ivermectin to treat COVID-19 and other prevention and investigational treatments and discuss with your health care provider.

The CDC are reporting adverse effects associated with ivermectin misuse and overdose are increasing. In some cases people have taken veterinary products intended for use in large animals such as horses, sheep, and cattle. These products are highly concentrated and result in overdoses when used by humans. DO NOT TAKE IVERMECTIN PRODUCTS INTENDED FOR ANIMAL USE.

Warnings

You will need to have a stool exam after taking ivermectin to make sure the infection is gone. Some patients may need to take another dose of ivermectin to treat the infection.

Ivermectin may make you feel dizzy. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.

Before taking this medicine

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

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

• liver or kidney disease; or
• cancer, HIV or AIDS, or other conditions that can weaken your immune system.

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

Ivermectin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ivermectin should not be given to a child who weighs less than 33 pounds (15 kg).

How should I take ivermectin?

Never take ivermectin in larger amounts, or for longer than recommended by your doctor. Follow all directions on your prescription label.

Take ivermectin on an empty stomach, at least 1 hour before or 2 hours after a meal.

Ivermectin is usually given as a single dose. Take this medicine with a full glass of water.

To effectively treat your infection, you may need to take ivermectin again several months to a year after your first dose.

If you have a weak immune system (caused by disease or by using certain medicine), you may need to take more than one dose of ivermectin. Some people who have a weak immune system need to take this medicine on a regular basis. Follow your doctor’s instructions.

To make sure this medicine is working, you may need to provide frequent stool samples.

Store this medicine at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Ivermectin for Onchocerciasis:

0.15 mg/kg orally once every 12 months
Patients with heavy ocular infection may require retreatment every 6 months. Retreatment may be considered at intervals as short as 3 months.

Dosage guidelines based on body weight:
15 to 25 kg: 3 mg orally one time
26 to 44 kg: 6 mg orally one time
45 to 64 kg: 9 mg orally one time
65 to 84 kg: 12 mg orally one time
85 kg or more: 0.15 mg/kg orally one time

Usual Adult Dose for Strongyloidiasis:

0.2 mg/kg orally once
In immunocompromised (including HIV) patients, the treatment of strongyloidiasis may be refractory requiring repeated treatment (i.e., every 2 weeks) and suppressive therapy (i.e., once a month), although well-controlled studies are not available. Cure may not be achievable in these patients.

Dosage guidelines based on body weight:
15 to 24 kg: 3 mg orally one time
25 to 35 kg: 6 mg orally one time
36 to 50 kg: 9 mg orally one time
51 to 65 kg: 12 mg orally one time
66 to 79 kg: 15 mg orally one time
80 kg or more: 0.2 mg/kg orally one time

Usual Adult Dose for Ascariasis:

0.2 mg/kg orally once

Usual Adult Dose for Cutaneous Larva Migrans:

0.2 mg/kg orally once

Usual Adult Dose for Filariasis:

0.2 mg/kg orally once

Study (n=26,000)
Mass treatment in Papua, New Guinea:
Bancroftian filariasis: 0.4 mg/kg orally once yearly (with a single annual dose of diethylcarbamazine 6 mg/kg), for 4 to 6 years

Usual Adult Dose for Scabies:

0.2 mg/kg orally once, and repeated in 2 weeks
Ivermectin therapy may be combined with a topical scabicide.

Usual Pediatric Dose for Filariasis:

Study (n=26,000)
Mass treatment in Papua, New Guinea:
Bancroftian filariasis:
5 years or older: 0.4 mg/kg orally once yearly (with a single annual dose of diethylcarbamazine 6 mg/kg), for 4 to 6 years

What happens if I miss a dose?

Since ivermectin is usually given in a single dose, you may not be on a dosing schedule. If you are on a schedule, 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 is Jadenu?

Jadenu binds to iron and removes it from the bloodstream.

Jadenu is usded in people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions.

Jadenu is also used in certain people 10 years of age or older with thalassemia who have an increased amount of iron in their blood but who are not receiving regular blood transfusions.

It is not known if Jadenu is safe and effective when used with other medicines to treat an increased amount of iron in the blood.

Warnings

You should not use Jadenu if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Deferasirox can harm your liver or kidneys. Call your doctor at once if you have swelling, shortness of breath, pain in your upper stomach, loss of appetite, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Jadenu may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Before taking this medicine

You should not use Jadenu if you are allergic to deferasirox, or if you have:

• severe liver or kidney disease;
• advanced cancer;
• a bone marrow disorder; or
• low levels of platelets in your blood.

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

• kidney disease;
• liver disease;
• anemia (low red blood cells);
• cancer (especially blood cell cancer such as leukemia);
• a stomach ulcer;
• stomach or intestinal bleeding;
• vision or hearing problems; or
• a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

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

Jadenu can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking Jadenu.

How should I take Jadenu?

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

Your doctor may perform certain tests to make sure you do not have conditions that would prevent you from safely using Jadenu.

Take Jadenu at the same time every day.

You may take this medicine on an empty stomach or with a small low-fat meal.

Swallow the Jadenu tablet whole with a full glass of water. If you cannot swallow the tablet whole, you may crush the tablet and mix it with yogurt, applesauce, or other soft food.

To take Jadenu Sprinkles, open the packet and sprinkle the medicine into a spoonful of soft food.

After mixing a crushed tablet or sprinkles with soft food, swallow the mixture right away without chewing. Do not save it for later use.

You may need frequent blood tests. Your kidney or liver function may also need to be checked every 6 months, and you may need a liver biopsy.

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 .

What should I avoid while taking Jadenu?

Do not use other iron-chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

Do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Jadenu may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Jadenu side effects

Get emergency medical help if you have signs of an allergic reaction to Jadenu (hives, difficult 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).

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

• problems with vision or hearing;
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts – fever, chills, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding, cold hands and feet, feeling light-headed or short of breath; or
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Serious side effects may be more likely in older adults.

Common Jadenu side effects may include:

• nausea, vomiting, stomach pain;
• diarrhea; or
• skin rash.

What is Jakafi?

Jakafi is used to treat certain types of myelofibrosis in adults.

Jakafi is also used to treat polycythemia vera in adults who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.

Jakafi is used to treat acute graft versus host disease (aGVHD) in adults and children 12 years of age and older who have taken corticosteroids and they did not work well enough.

Jakafi works by blocking certain enzymes in the body that affect blood cell production.

Warnings

You should not use Jakafi if you are allergic to ruxolitinib, or if you have severe kidney disease.

Before you take this medicine, tell your doctor if you have liver or kidney disease, if you are on dialysis, or if you are pregnant.

You should not breast-feed while you are using this medicine.

To be sure Jakafi is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine the best dose for you to use. When you first start taking this medicine, your blood will need to be tested every 2 to 4 weeks. Do not miss any follow-up visits to your doctor.

Grapefruit and grapefruit juice may interact with Jakafi and can affect the amount of the medication in your blood. Discuss the use of grapefruit products with your doctor.

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 Jakafi if you are allergic to ruxolitinib.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also, tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

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

• any type of infection;
• shingles (herpes zoster);
• a blood clot, stroke, heart attack, or other heart problems;
• low white or red blood cell counts;
• any type of cancer;
• are a current or past smoker;
• kidney disease (or if you are on dialysis);
• liver disease (especially hepatitis B); or
• high cholesterol or triglycerides (types of fat in the blood).

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

Do not breastfeed while using Jakafi, and for at least 2 weeks after your last dose.

Jakafi is not approved for the treatment of myelofibrosis or polycythemia vera by anyone younger than 18 years old.

How should I take Jakafi?

Take Jakafi 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. You will need frequent medical tests to help your doctor determine the best dose.

You may take Jakafi with or without food. The Jakafi tablet can also be given through a nasogastric (NG) feeding tube.

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

If you are on dialysis, Jakafi should be taken after your dialysis.

Using Jakafi may increase your risk of developing other cancers. Ask your doctor about this risk.

Store at room temperature away from moisture and heat.

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

You may be given other medications to help prevent infection. Keep taking these medicines for as long as your doctor has prescribed.

Dosing information

Usual Adult Dose of Jakafi for Myeloproliferative Disorder:

Doses should be titrated based on safety and efficacy; CBC (complete blood count) and platelet counts should be performed every 2 to 4 weeks until doses are stabilized and then as clinically indicated

Initial Dose Based on Platelet Count:
-Platelets greater than 200 x 10⁹/L: 20 mg orally twice a day
-Platelets 100 x 10(9)/L to 200 x 10⁹/L: 15 mg orally twice a day
-Platelets 50 x 10⁹/L to less than 100 x 10⁹/L: 5 mg orally twice a day

Comments:
-Based on limited clinical data, long-term maintenance at 5 mg twice a day has not shown benefit; this dose should be limited to patients for whom the benefits outweigh the potential risks.
-Discontinue therapy if there is no spleen size reduction or symptom improvement after 6 months of therapy.

Uses:
-For the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

Usual Adult Dose of Jakafi for Graft Versus Host Disease:

Monitor complete blood counts (CBC), including platelet count and ANC, and bilirubin prior to
initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as indicated clinically:

Acute Graft-Versus-Host Disease (GVHD): Initial dose: 5 mg orally 2 times a day
-Dose titration: Consider increasing dose to 10 mg orally 2 times a day after at least 3 days if the ANC (absolute neutrophil count) and platelet counts are not decreased by 50% or more relative to the first day of dosing
Duration of therapy: Consider tapering after 6 months for those with response who have stopped therapeutic doses of corticosteroids; taper by 1 dose level every 8 weeks (see comments); if signs or symptoms of GVHD recur during or after taper, consider retreatment

Chronic GVHD: Initial dose: 10 mg orally 2 times a day
-Duration of therapy: Consider tapering after 6 months for those with response who have stopped therapeutic doses of corticosteroids; taper by 1 dose level every 8 weeks (see comments); if signs or symptoms of GVHD recur during or after taper, consider retreatment

Comments:
-Dose level decreases: 10 mg twice a day to 5 mg twice a day to 5 mg once a day.
-See Dose Adjustment section for dose modification guidance for adverse reactions.

Uses: For the treatment of steroid-refractory acute GVHD and treatment of chronic GVHD after failure of 1 or 2 lines of systemic therapy.

Usual Adult Dose of Jakafi for Polycythemia Vera:

Doses should be titrated based on safety and efficacy; CBC and platelet counts should be performed every 2 to 4 weeks until doses are stabilized and then as clinically indicated

Initial dose: 10 mg orally twice a day
-Dose may be titrated based on safety and efficacy

Use: For treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Usual Pediatric Dose of Jakafi for Graft Versus Host Disease:

12 years or older:

Monitor complete blood counts (CBC), including platelet count and ANC, and bilirubin prior to
initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as indicated clinically:

Acute Graft-Versus-Host Disease (GVHD): Initial dose: 5 mg orally 2 times a day
-Dose titration: Consider increasing dose to 10 mg orally 2 times a day after at least 3 days if the ANC (absolute neutrophil count) and platelet counts are not decreased by 50% or more relative to the first day of dosing
Duration of therapy: Consider tapering after 6 months for those with response who have stopped therapeutic doses of corticosteroids; taper by 1 dose level every 8 weeks (see comments); if signs or symptoms of GVHD recur during or after taper, consider retreatment

Chronic GVHD: Initial dose: 10 mg orally 2 times a day
-Duration of therapy: Consider tapering after 6 months for those with response who have stopped therapeutic doses of corticosteroids; taper by 1 dose level every 8 weeks (see comments); if signs or symptoms of GVHD recur during or after taper, consider retreatment

Comments:
-Dose level decreases: 10 mg twice a day to 5 mg twice a day to 5 mg once a day.
-See Dose Adjustment section for dose modification guidance for adverse reactions.

Uses: For the treatment of steroid-refractory acute GVHD and treatment of chronic GVHD after failure of 1 or 2 lines of systemic therapy in pediatric patients 12 years or older.

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 Jakafi?

Grapefruit may interact with ruxolitinib and cause side effects. Avoid consuming grapefruit products.

Jakafi side effects

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

Some side effects may be similar to the symptoms of myelofibrosis. Call your doctor at once if you have:

• changes in the size, shape, or color of a mole or skin lesion;
• problems with speech, thought, vision, or muscle movement (these symptoms may start gradually and get worse quickly);
• nausea, vomiting, weakness, general ill feeling;
• cold sores around your mouth, skin sores or blisters, itching, tingling, skin rash, burning pain in your thigh or lower back;
• pain in your arms, back, neck, jaw, or stomach;
• signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body – pain, swelling, or warmth in one leg;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• 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; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Jakafi side effects may include:

• low blood cell counts;
• swelling;
• infection;
• bruising;
• diarrhea;
• dizziness; or
• headache.

What is Jadenu Sprinkle?

Jadenu Sprinkle binds to iron and removes it from the bloodstream.

Jadenu Sprinkle is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Jadenu Sprinkle is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.

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

Jadenu Sprinkle 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 in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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

• problems with vision or hearing;
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts–fever, chills, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding, cold hands and feet, feeling light-headed or short of breath; or
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Serious side effects may be more likely in older adults.

Common side effects of Jadenu Sprinkle may include:

• nausea, vomiting, stomach pain;
• diarrhea; 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

You should not use Jadenu Sprinkle if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Jadenu Sprinkle can harm your liver or kidneys. Call your doctor at once if you have swelling, shortness of breath, pain in your upper stomach, loss of appetite, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Jadenu Sprinkle may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Before taking this medicine

You should not use this medication if you are allergic to it, or if you have:

• severe liver or kidney disease;
• advanced cancer;
• a bone marrow disorder; or
• low levels of platelets in your blood.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• anemia (low red blood cells);
• cancer (especially blood cell cancer such as leukemia);
• a stomach ulcer;
• stomach or intestinal bleeding;
• vision or hearing problems; or
• a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

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

Jadenu Sprinkle can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking Jadenu Sprinkle.

How should I take Jadenu Sprinkle?

Your doctor may perform certain tests to make sure you do not have conditions that would prevent you from safely using Jadenu Sprinkle.

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

Take Jadenu Sprinkle at the same time every day.

Take Exjade on an empty stomach at least 30 minutes before eating.

You may take Jadenu on an empty stomach or with a small low-fat meal.

Swallow the Jadenu tablet whole with a full glass of water. If you cannot swallow the Jadenu tablet whole, you may crush the tablet and mix it with yogurt, applesauce, or other soft food.

To take Jadenu Sprinkles, open the packet and sprinkle the medicine into a spoonful of soft food.

After mixing a crushed tablet or sprinkles with soft food, swallow the mixture right away without chewing. Do not save it for later use.

Do not chew or crush the Exjade dispersible tablet, and do not swallow it whole. Place the tablet into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

If you take less than 1000 milligrams (1 gram) daily, dissolve the Exjade dispersible tablet in about one-half cup of apple juice, orange juice, or water. If you take more than 1000 milligrams daily, dissolve the tablet in about 1 cup of apple juice, orange juice, or water.

You may need frequent blood tests. Your kidney or liver function may also need to be checked every 6 months, and you may need a liver biopsy.

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 .

What should I avoid while taking Jadenu Sprinkle?

Do not use other iron-chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

Do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Jadenu Sprinkle may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What is Jalyn?

Jalyn contains a combination of dutasteride and tamsulosin. Dutasteride prevents testosterone from converting to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Jalyn is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Warnings

Jalyn should never be handled or taken by a woman, a child, or a teenager. Dutasteride can be absorbed through the skin. This medication can cause birth defects if a woman is exposed to it during pregnancy. The capsules should not be handled by a woman who is pregnant or who may become pregnant. If a woman accidentally comes into contact with the medication from a leaking capsule, wash the area with soap and water right away. Do not donate blood while taking Jalyn and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

You should not use Jalyn if you are allergic to dutasteride (Avodart) or tamsulosin (Flomax). Do not take this medicine if you are also taking alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

There are many other drugs that can interact with dutasteride and tamsulosin. Tell your doctor about all medications you use.

Jalyn should never be taken by a woman, a child, or a teenager.

Jalyn may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using this medicine.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using Jalyn before surgery unless your surgeon tells you to.

Before taking this medicine

You should not use Jalyn if you are allergic to dutasteride, finasteride, or tamsulosin.

You should not take this medicine while you are taking tamsulosin (Flomax) or similar medicines, such as alfuzosin, doxazosin, prazosin, silodosin, or terazosin.

Jalyn should never be taken by a woman, a child, or a teenager. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle Jalyn capsules.

This medicine is not for use by women. This medicine can cause birth defects. The capsules should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a leaking capsule, wash the area with soap and water right away.

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

• high or low blood pressure;
• liver or kidney disease;
• prostate cancer; or
• an allergy to sulfa drugs.

Using this medicine may increase your risk of developing prostate cancer. Ask your doctor about this risk.

Jalyn can affect your pupils. If you need eye surgery, tell the surgeon about your use of this medicine, even if you no longer take it.

How should I take Jalyn?

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

Take this medicine 30 minutes after a meal, at the same time each day.

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

You will need medical tests to check your prostate specific antigen (PSA).

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Benign Prostatic Hyperplasia:

Dutasteride 0.5 mg-Tamsulosin 0.4 mg orally once a day approximately 30 minutes after the same meal each day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

What happens if I miss a dose?

Take your dose as soon as you can, but only within 30 minutes after a meal. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor if you miss your doses for several days in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Jalyn?

Avoid taking medicines for erectile dysfunction (sildenafil, avanafil, Viagra, Cialis, and others).

Do not donate blood while taking this medicine and for at least 6 months after your last dose. Dutasteride could cause birth defects if a pregnant women receives a transfusion with blood that contains this medicine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Jalyn side effects

Get emergency medical help if you have signs of an allergic reaction to Jalyn (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 this medicine and call your doctor at once if you have:

• a light-headed feeling, like you might pass out; or
• penis erection that is painful or lasts 4 hours or longer.

Common Jalyn side effects may include:

• decreased libido (sex drive);
• decreased amount of semen released during sex;
• impotence (trouble getting or keeping an erection);
• breast tenderness or enlargement;
• dizziness; or
• runny nose.

What is Jantoven?

Jantoven is an anticoagulant (blood thinner). This medicine reduces the formation of blood clots.

Jantoven is used to treat or prevent blood clots in veins or arteries, which can reduce the risk of stroke, heart attack, or other serious conditions.

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

Jantoven 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.

Jantoven increases your risk of bleeding, which can be severe or life-threatening. Call your doctor at once if you have any signs of bleeding such as:

• sudden headache, feeling very weak or dizzy;
• swelling, pain, unusual bruising;
• bleeding gums, nosebleeds;
• bleeding from wounds or needle injections that will not stop;
• heavy menstrual periods or abnormal vaginal bleeding;
• blood in your urine, bloody or tarry stools; or
• coughing up blood or vomit that looks like coffee grounds.

Clots formed by Jantoven may block normal blood flow, which could lead to tissue death or amputation of the affected body part. Get medical help at once if you have:

• pain, swelling, hot or cold feeling, skin changes, or discoloration anywhere on your body; or
• sudden and severe leg or foot pain, foot ulcer, purple toes or fingers.

Bleeding is the most common side effect of warfarin.

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 take Jantoven if you are prone to bleeding because of a medical condition, if you have an upcoming surgery, or if you need a spinal tap or epidural. Do not take this medicine if you cannot take it on time every day.

Jantoven increases your risk of severe or fatal bleeding, especially if you have certain medical conditions, if you are 65 or older, or if you have had a stroke, or bleeding in your stomach or intestines. Seek emergency help if you have any bleeding that will not stop.

Call your doctor at once if you have other signs of bleeding such as: swelling, pain, feeling very weak or dizzy, unusual bruising, bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with Jantoven. Tell your doctor about all medicines you have recently used.

Avoid making any changes in your diet without first talking to your doctor. Some foods can make Jantoven less effective.

Before taking this medicine

You should not take Jantoven if you are allergic to it, or if:

• you have very high blood pressure;
• you recently had or will have surgery on your brain, spine, or eye;
• you undergo a spinal tap or spinal anesthesia (epidural); or
• you cannot take Jantoven on time every day.

You also should not take Jantoven if you are are prone to bleeding because of a medical condition, such as:

• a blood cell disorder (such as low red blood cells or low platelets);
• ulcers or bleeding in your stomach, intestines, lungs, or urinary tract;
• an aneurysm or bleeding in the brain; or
• an infection of the lining of your heart.

Do not take Jantoven if you are pregnant, unless your doctor tells you to. This medicine can cause birth defects, but preventing blood clots may outweigh any risks to the baby. If you are not pregnant, use effective birth control to prevent pregnancy while taking this medicine and for at least 1 month after your last dose. Tell your doctor right away if you become pregnant.

Jantoven can make you bleed more easily, especially if you have ever had:

• high blood pressure or serious heart disease;
• kidney disease;
• cancer or low blood cell counts;
• an accident or surgery;
• bleeding in your stomach or intestines;
• a stroke; or
• if you are 65 or older.

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

• diabetes;
• congestive heart failure;
• liver disease, kidney disease (or if you are on dialysis);
• a hereditary clotting deficiency; or
• low blood platelets after receiving heparin.

It is not known whether warfarin passes into breast milk. Watch for signs of bruising or bleeding in the baby if you take warfarin while you are breast-feeding a baby.

How should I take Jantoven?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take Jantoven in larger or smaller amounts or for longer than your doctor tells you to.

Take Jantoven at the same time every day, with or without food. Never take a double dose.

Jantoven can make it easier for you to bleed. Seek emergency help if you have any bleeding that will not stop.

You will need frequent “INR” or prothrombin time tests (to measure your blood-clotting time and determine your Jantoven dose). You must remain under the care of a doctor while taking this medicine.

If you receive Jantoven in a hospital, call or visit your doctor 3 to 7 days after you leave the hospital. Your INR will need to be tested at that time. Do not miss any follow-up appointments.

Tell your doctor if you are sick with diarrhea, fever, chills, or flu symptoms, or if your body weight changes.

You may need to stop taking Jantoven 5 to 7 days before having any surgery, dental work, or a medical procedure. Call your doctor for instructions.

Wear a medical alert tag or carry an ID card stating that you take Jantoven. Any medical care provider who treats you should know that you are taking Jantoven.

Store at room temperature away from heat, moisture, and light.

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 can cause excessive bleeding.

What should I avoid while taking Jantoven?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth. You may still bleed more easily for several days after you stop taking Jantoven.

Avoid making any changes in your diet without first talking to your doctor. Foods that are high in vitamin K (liver, leafy green vegetables, or vegetable oils) can make Jantoven less effective. If these foods are part of your diet, eat a consistent amount on a weekly basis.

Grapefruit juice, cranberry juice, noni juice, and pomegranate juice may interact with Jantoven and lead to unwanted side effects. Avoid the use of these juice products while taking this medicine.

Avoid drinking alcohol.

Ask your doctor before using any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. These medicines may affect blood clotting and may also increase your risk of stomach bleeding.

What is Janumet?

Janumet contains a combination of metformin and sitagliptin. Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.

Janumet is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Janumet is not used to treat type 1 diabetes.

Warnings

You should not use Janumet if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Janumet may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Janumet may also lead to a serious condition called pancreatitis. Call your doctor right away if you have severe stomach pains with or without vomiting.

Before taking this medicine

You should not use Janumet if you are allergic to metformin or sitagliptin (Januvia), or if you have severe kidney disease.

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

• kidney disease (your kidney function may need to be checked before and while you are taking this medicine);
• liver disease;
• heart disease;
• pancreatitis;
• high triglycerides (a type of fat in the blood);
• gallstones; or
• alcoholism.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, surgery, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Janumet. Be sure your caregivers know ahead of time that you are using this medication.

Follow your doctor’s instructions about using Janumet if you are pregnant or you become pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Your dose needs may also be different while you are breastfeeding.

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

How should I take Janumet?

Take Janumet 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.

Take Janumet with meals.

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

Janumet tablets may not completely dissolve in the body. Part of the tablet may appear in your stool. This is a normal side effect of Janumet and will not make the medicine less effective.

Call your doctor if you see a tablet in your stool several times.

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, blurred vision, headache, and tiredness.

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.

Janumet 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.

Your blood will need to be tested often.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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 at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Janumet side effects

Get emergency medical help if you have signs of an allergic reaction to Janumet: (hives, difficult 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).

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• slow or irregular heartbeat.

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

• itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints;
• little or no urinating; or
• shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain; or
• signs of low blood sugar, including headache, sleepiness, dizziness, sweating, feeling jittery, hunger, or fast heartbeat.

Common Janumet side effects may include:

cold symptoms such as runny or stuffy nose, sneezing, sore throat.

What is Janumet XR?

Janumet XR is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus (not for type 1 diabetes).

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

Janumet XR 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 taking Janumet XR and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people using Janumet XR develop lactic acidosis, which can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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

• severe or ongoing pain in your joints;
• a severe skin reaction— itching, blisters, breakdown of the outer layer of skin;
• kidney problems or symptoms of heart failure–swelling, urinating less, rapid weight gain, feeling tired or short of breath; or
• severely low blood sugar–extreme weakness, confusion, tremors, sweating, fast heartbeats, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

Common side effects of Janumet XR may include:

• low blood sugar (if you also use insulin or another oral diabetes medication);
• upset stomach, indigestion, gas, diarrhea, nausea, vomiting;
• headache, weakness; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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 Janumet XR if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

You should not use Janumet XR if you are allergic to it, or if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

Tell your doctor if you have or have ever had:

• heart problems such as heart attack, heart failure, or stroke;
• pancreatitis;
• low levels of vitamin B12 or calcium in your blood;
• high triglycerides (a type of fat in the blood);
• gallstones;
• alcoholism; or
• liver or kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Janumet XR. Make sure that your healthcare provider knows ahead of time that you are using this medication.

It is not known if Janumet XR will harm an unborn baby. Follow your doctor’s instructions about using Janumet XR if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Janumet XR?

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.

Janumet XR is usually taken either once or twice a day based on the form of this medicine. Follow your doctor’s instructions.

Take Janumet XR with meals. Take the extended-release tablet once daily with your meal.

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

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting, diarrhea, fever, or if you drink liquids less than usual.

Call your doctor if you see the extended-release tablet in your stool several times.

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 injection 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.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat. Certain brands must be stored in the original container and used within 1 to 3 months.

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 Janumet XR?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

What other drugs will affect Janumet XR?

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine including rosiglitazone.

Many drugs can increase your risk of lactic acidosis or affect your blood sugar and may also affect Janumet XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. 

What is Januvia?

Januvia is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Januvia is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Januvia is not for treating type 1 diabetes.

Warnings

You should not use Januvia if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Call your doctor if you have symptoms of heart failure–shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Stop taking Januvia and call your doctor if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting.

Before taking this medicine

You should not use Januvia if you are allergic to sitagliptin, or if you have diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• heart problems;
• pancreatitis;
• high triglycerides (a type of fat in the blood);
• gallstones; or
• alcoholism.

Follow your doctor’s instructions about using Januvia if you are pregnant or you become pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester. Having high blood sugar may cause complications in both the mother and the baby.

Your name may need to be listed on a Januvia pregnancy registry when you start using this medicine.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

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

How should I take Januvia?

Take Januvia exactly as it was prescribed for you. 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.

You may take Januvia with or without food. Follow your doctor’s instructions.

Your blood sugar may need to be checked often, and you may need other blood tests at your doctor’s office.

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, blurred vision, headache, and tiredness.

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.

Januvia is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Diabetes Type 2:

Usual dose: 100 mg orally once a day

Comments: When used in combination with an insulin secretagogue (e.g. sulfonylurea) or insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

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 . You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What to avoid

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

Januvia side effects

Get emergency medical help if you have signs of an allergic reaction to Januvia (hives, difficult 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).

Stop taking Januvia and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting.

Call your doctor at once if you have:

• severe autoimmune reactionitching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints;
• little or no urination; or
• symptoms of heart failureshortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Januvia side effects may include:

• low blood sugar;
• headache; or
• runny or stuffy nose, sore throat.

What is Jardiance?

Jardiance (empagliflozin) is an FDA-approved tablet used to help control blood sugar levels in type 2 diabetes and is also used to reduce the risk of cardiovascular problems in adults with heart failure or cardiovascular disease with type 2 diabetes. Jardiance lowers blood glucose levels (HbA1c) by helping the kidney increase the amount of glucose passing into the urine. Jardiance should be used together with diet and exercise when prescribed for type 2 diabetes.

Jardiance 10mg tablets are also used for chronic kidney disease (CKD) in adults that have risk of disease progression. In CKD Jardiance is used to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization.

Jardiance is from the class of medicines called SGLT-2 inhibitors (sodium-glucose cotransporter-2 inhibitors).  Jardiance works for type 2 diabetes by blocking SGLT-2 proteins located in the renal tubules of the kidneys, which are responsible for reabsorbing glucose back into the bloodstream.

The way Jardiance works to reduce the risk of cardiovascular or heart failure is thought to be related to changes in heart muscle metabolism from favoring the use of glucose to using a more balanced combination of fatty acids, ketone bodies (ketone), branched-chain amino acids (BCAA) and glucose. Jardiance also improves the heart’s diastolic stiffness and diastolic function.

Type 2 diabetes is a long-term condition when your blood sugars (HbA1c) become too high because the body does not produce or use insulin normally.  Over time high blood sugar can cause serious health problems, including heart disease, vision loss, and kidney disease. By having better control of blood sugar levels helps reduce the risk of complications of diabetes.

Who can use Jardiance?

Jardiance is used for:

• adults with type 2 diabetes mellitus to lower blood sugar levels when used with diet and exercise
• adults with heart failure to reduce the risk of cardiovascular death and hospitalization.
• adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death 
• to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression

Jardiance is not recommended:

• for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis  (increased ketones in blood or urine) in these patients.
• to improve blood sugar levels in adults with type 2 diabetes mellitus who have severe kidney problems (if their eGFR is less than 30 mL/min/1.73 m2).
• for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease as Jardiance is not expected to be effective in these populations. 

Jardiance side effects

Common Jardiance side effects 

Common Jardiance side effects include:

• a bladder infection or urinary tract infection (7.6%)
• vaginal yeast infection (5.4%)
• upper respiratory tract infection (3.1%)
• increased urinary frequency (3.4%)
• increased cholesterol levels (3.9%)
• joint pain (2.4%)
• male genital yeast infection (3.1%) 
• nausea (2.3%)

These common side effects occurred in  2% or more of patients on Jardiance 10mg tablets.

Serious Jardiance side effects

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

Necrotizing Fasciitis of the Perineum Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or not feeling well. These symptoms may get worse quickly.

Amputations. Jardiance belongs to a group of medicines called SGLT2 inhibitors which may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you have a history of amputation, have had blocked or narrowed blood vessels usually in your leg, or have had diabetic foot infection, ulcers, or sores. Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.

Other serious side effect symptoms, call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• low blood sugar – headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• dehydration – dizziness, confusion, feeling very thirsty, less urination;
• ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• signs of a bladder infection – pain or burning when you urinate, blood in your urine, pain in pelvis or back.

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

Call your doctor at once if you have signs of a serious side effect, such as stomach pain, vomiting, tiredness, or trouble breathing.

You should not use Jardiance if you have severe kidney disease or if you are on dialysis, or if you have diabetic ketoacidosis.

Taking Jardiance can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Jardiance can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don’t feel well.

Before taking this medicine

You should not use Jardiance if you are allergic to empagliflozin, any of the inactive tablet ingredients, or if you have:

• severe kidney disease (or if you are on dialysis).

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

• a bladder infection or urination problems;
• a genital infection (penis or vagina);
• problems with your pancreas, including surgery;
• have a history of amputation;
• have type 1 diabetes or have had diabetic ketoacidosis;
• have a decrease in your insulin dose;
• are eating less, or there is a change in your diet;
• alcoholism, or if you currently drink large amounts of alcohol;
• if you are on a low salt diet, you are eating less, or there is a change in your diet;
• if you are 65 or older; or
• liver or kidney disease.

Jardiance is not for treating type 1 diabetes.

Pregnancy

Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. You should not use Jardiance during the second or third trimester of pregnancy. 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.

Talk to your doctor if you are breastfeeding or plan to breast feed. Do not breastfeed while you are taking Jardiance. This medicine may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking this medicine.

How should I take Jardiance?

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

Jardiance instructions:

• Jardiance is a tablet that you take by mouth.
• Jardiance is usually take once daily in the morning. You should take it at around the same time each day.
• You may take this medicine with or without food.

• Your doctor may start you on a low dose of this medicine and increase your dose as needed.
• Do not take more or less of it or take it more often than prescribed by your doctor.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. This medicine can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

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 injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

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

Your treatment may also include diet, exercise, weight control, and special medical care.

Tell your doctor if you have a planned surgery.

Dosing information

Usual Dose of Jardiance for Diabetes Type 2:

Patients aged 10 years and older.

Initial dose: 10 mg orally once a day in the morning.

Dose increase: Dose may be increased to 25 mg orally once a day for patients tolerating therapy and requiring additional glycemic control.

Maximum dose: 25 mg per day.

Usual Adult Dose for Cardiovascular Risk Reduction:

Initial dose: 10 mg orally once a day in the morning, with or without food.

Use: Reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus with established cardiovascular disease.

Usual Adult Dose for Heart Failure with Reduced Ejection Fraction:

Dose: 10 mg orally once a day

Use: Reduce the risk of cardiovascular death and hospitalization in patients with heart failure  

Usual Jardiance Dose for adults with chronic kidney disease that is at risk of progression.

Dose: 10 mg orally once daily in the morning, taken with or without food. 

Use: To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease that is at risk of progression.

General Dose Comments:

• Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
• Not recommended to improve glycemic control in patients with an eGFR less than 30 mL/min/1.73 m2 as it is unlikely to be effective.
• Volume depletion should be corrected prior to initiating therapy.

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 Jardiance?

• Avoid drinking alcohol.
• Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What other drugs will affect Jardiance?

Other drugs may increase or decrease the effects of Jardiance on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• angiotensin-converting enzyme (ACE) inhibitors eg benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Qbrelis, Zestril, in Zestoretic), moexipril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril. 
• angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Diovan HCT, in Exforge). 
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); digoxin (Lanoxin);
• diuretics (‘water pills’). 
• insulin or oral medications for diabetes such as glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), and tolbutamide. 

What is Jemperli?

Jemperli is a cancer immunotherapy used to treat types of endometrial cancer and solid tumors. Jemperli belongs to the class of drugs called programmed death receptor-1 (PD-1)–blocking antibodies. In tumors, a protein (PD-1) on immune cells (T-cells) makes them inactive, preventing them from killing cancer cells. Jemperli works by binding to PD-1, which activates the T-cells, and then they can find, attack, and kill the cancer cells.

Jemperli (dostarlimab-gxly) is given as an intravenous infusion into your vein over 30 minutes every 3 to 6 weeks, depending on your treatment regime. Jemperli can be used as a single medicine or used with carboplatin and paclitaxel to treat certain cancers.

Jemperli is FDA-approved to treat adult patients with:

• Primary advanced or recurrent endometrial cancer, regardless of biomarker status. To be used in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has been confirmed with an FDA-approved test. Endometrial cancer must have progressed on or following prior treatment with a platinum-containing regimen in any setting, and patients are not candidates for curative surgery or radiation. It is to be used as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced solid tumors confirmed with an FDA-approved test. Solid tumors must have progressed on or following prior treatment, and there are no satisfactory alternative treatment options. It is to be used as a single agent.

Jemperli side effects

Common Jemperli side effects

Common Jemperli side effects when used alone in people with dMMR solid tumors (including endometrial cancer) include:

• tiredness and weakness
• low red blood cell count (anemia)
• diarrhea
• nausea
• constipation
• vomiting.

The most Jemperli common side effects when given with carboplatin and paclitaxel in people with endometrial cancer include:

• nerve problems in your arms, hands, legs, and feet
• joint pain
• shortness of breath
• rash
• decreased appetite
• tiredness
• constipation
• urinary tract infections
• nausea
• diarrhea
• vomiting
• hair loss
• stomach-area (abdomen) pain.

Serious Jemperli side effects

Get emergency medical help if you have signs of an allergic reaction to Jemperli (hives, difficulty 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).

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, chilled, feverish, itchy, or short of breath.

Jemperli strengthens your immune system to help it attack cancer cells, but it may also attack healthy cells, and you could develop serious or fatal side effects.

Also, see the Important Information section.

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

Important information

Jemperli can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment with Jemperli has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

• cough
• chest pain
• shortness of breath

Intestinal problems (colitis) can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• diarrhea or more bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems, including hepatitis. Signs and symptoms of liver problems may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

• change in the amount or color of your urine
• blood in your urine
• swelling in your ankles
• loss of appetite

Skin problems. Signs of skin problems may include:

• rash
• itching
• skin blistering or peeling
• swollen lymph nodes
• painful sores or ulcers in your mouth or your nose, throat, or genital area
• fever or flu-like symptoms

Problems in other organs and tissues. These are not all of the signs and symptoms of immune system problems. Call or see your healthcare provider right away for any new or worse signs or symptoms. Signs and symptoms of these problems may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Jemperli. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach area (abdominal) pain, and diarrhea.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare provider may also need to delay or completely stop treatment.

Before receiving Jemperli

Before you receive Jemperli, tell your healthcare provider if you have any medical conditions, including if you:

• have immune system problems, such as Crohn’s disease, ulcerative colitis, or lupus.
• have received an organ transplant.
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic).
• have received radiation treatment to your chest area.
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Jemperli can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment.
• You should use effective birth control during treatment and for 4 months after your last dose. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Jemperli.

Breastfeeding

Tell your healthcare provider you are breastfeeding or plan to breastfeed. It is not known if Jemperli passes into your breast milk.

• Do not breastfeed during treatment and for 4 months after your last dose.

How will I receive Jemperli?

• Your healthcare provider will give you Jemperli into your vein through an intravenous (IV) line over 30 minutes.
• When Jemperli is used in combination with carboplatin and paclitaxel, Jemperli is usually given every 3 weeks for the first 6 doses. Beginning 3 weeks later, it is usually given alone every 6 weeks.
• When Jemperli is used alone to treat dMMR recurrent or advanced endometrial cancer and dMMR recurrent or advanced solid tumors, it is usually given every 3 weeks for the first 4 doses. Beginning 3 weeks later, it is usually given every 6 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Jemperli Dosing information

Usual adult Jemperli dose for primary advanced or recurrent endometrial cancer.

Dose: Jemperli dose (in combination with carboplatin and paclitaxel) 500 mg every 3 weeks for 6 cycles followed by 1,000 mg monotherapy every 6 weeks for all cycles thereafter.

Usual adult dose for dMMR recurrent or advanced endometrial cancer

Dose: Jemperli (as a single agent) 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.

Usual adult dose for dMMR recurrent or advanced solid tumors

Dose: Jemperli (as a single agent) 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.

General Dosing Information

• Jemperli is given as an intravenous infusion over 30 minutes.
• Click on the link below for more detailed dosing information.

What other drugs will affect Jemperli?

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

Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

Jemperli Package Insert

Review the Jemperli Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. 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.

What are the ingredients in Jemperli?

Active ingredient: dostarlimab-gxly

Inactive ingredients: citric acid monohydrate, L-arginine hydrochloride, polysorbate 80, sodium chloride, trisodium citrate dihydrate, and Water for Injection

What is Jencycla?

Jencycla is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Jencycla is used for birth control (contraception) to prevent pregnancy.

Jencycla is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of Jencycla are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

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

Jencycla 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.

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

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of Jencycla may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

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 Jencycla if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take Jencycla if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take Jencycla if you are nursing.

Before taking this medicine

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

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use Jencycla if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take Jencycla if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take Jencycla?

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

Carefully follow your doctor’s dosing instructions about when to start taking Jencycla for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take Jencycla for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take Jencycla for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take Jencycla for endometriosis: This medicine is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

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

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of Jencycla is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking Jencycla for contraception.

Jencycla will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect Jencycla?

Some drugs can make Jencycla less effective, which may result in unintended pregnancy if you use Jencycla for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

What is Jentadueto?

Jentadueto contains a combination of linagliptin and metformin. Linagliptin and metformin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Jentadueto is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Warnings

You should not use Jentadueto if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

There may be an increased risk of developing lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before you take Jentadueto, tell your doctor if you have liver disease, a serious infection, heart disease, a history of pancreatitis, if you have recently had a heart attack, or if you are over 65 years old and have not recently had your kidney function checked.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto.

You may develop lactic acidosis. Get emergency medical help if you have unusual muscle pain, trouble breathing, irregular heartbeats, dizziness, vomiting, or if you feel cold, tired, or very weak.

Before taking this medicine

You should not use Jentadueto if you are allergic to linagliptin (Tradjenta) or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

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

• kidney disease;
• heart disease;
• liver disease;
• gallstones;
• pancreatitis;
• alcoholism; or
• high triglycerides (a type of fat in the blood).

You may develop lactic acidosis. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Jentadueto 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.

Jentadueto may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

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

How should I take Jentadueto?

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

Take Jentadueto with a meal, unless your doctor tells you otherwise.

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

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.

Jentadueto is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Diabetes Type 2:

Linagliptin-metformin immediate release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 2.5 mg/metformin 500 mg orally twice a day
-Initial dose for patients currently receiving metformin: linagliptin 2.5 mg in combination with one-half of current metformin dose orally twice a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing the same doses of each component orally twice a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Linagliptin-metformin extended-release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 5 mg/metformin extended-release 1000 mg orally once a day
-Initial dose for patients currently receiving metformin: linagliptin 5 mg in combination with a similar total daily dose of metformin orally once a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing similar doses of each component orally once a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Comments:
-Patients taking two linagliptin 2.5 mg/metformin 1000 mg extended-release tablets should take the 2 tablets together once a day.
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be necessary to reduce the risk of hypoglycemia.

Use: To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise when treatment with both linagliptin and metformin are appropriate.

What happens if I miss a dose?

Take the medicine (with food) 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 . You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Jentadueto side effects

Get emergency medical help if you have signs of an allergic reaction to Jentadueto: (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 taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• a severe autoimmune reaction – itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints; or
• symptoms of heart failure – shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Jentadueto side effects include:

• sore throat;
• sinus pain, stuffy nose; or
• diarrhea.

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 Jentadueto?

Many drugs can interact with linagliptin and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Jentadueto XR?

Jentadueto XR are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Jentadueto XR is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Jentadueto XR is not for treating type 1 diabetes.

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

Jentadueto XR 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 taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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

• a severe autoimmune reaction–itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints; or
• symptoms of heart failure–shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of Jentadueto XR may include:

• sore throat;
• sinus pain, stuffy nose; or
• diarrhea.

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 Jentadueto XR if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Get emergency medical help if you have unusual muscle pain, trouble breathing, irregular heartbeats, dizziness, vomiting, or if you feel cold, tired, or very weak.

Before taking this medicine

You should not use this medicine if you are allergic to linagliptin (Tradjenta) or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease;
• heart disease;
• liver disease;
• pancreatitis;
• gallstones;
• alcoholism; or
• high triglycerides (a type of fat in the blood).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto XR. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using this medicine 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.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

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

How should I take Jentadueto XR?

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

Take Jentadueto XR with a meal, unless your doctor tells you otherwise.

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

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.

Jentadueto XR is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine (with food) 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 . You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What should I avoid while taking Jentadueto XR?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

What is Jeuveau?

Jeuveau is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles.

Jeuveau is a prescription medicine used to temporarily lessen the appearance of facial wrinkles (frown lines) between the eyebrows) in adults.

It is not known if Jeuveau is safe and effective for use in children.

Warnings

The botulinum toxin contained in Jeuveau can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe eye irritation, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing.

Before taking this medicine

You should not be treated with Jeuveau if you are allergic to prabotulinumtoxinA, or if:

• you have an infection in the area where the medicine will be injected; or
• you have ever had an allergic reaction to any product that contains botulinum toxin, such as Botox, Dysport, Myobloc, or Xeomin.

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

• other botulinum toxin injections such as Dysport or Myobloc (especially in the last 4 months);
• amyotrophic lateral sclerosis (ALS, or “Lou Gehrig’s disease”);
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a side effect after prior use of botulinum toxin;
• a breathing disorder such as asthma or emphysema;
• problems with swallowing;
• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
• bleeding problems;
• heart disease; or
• surgery (especially on your face).

Tell your doctor if you are pregnant or breastfeeding.

Jeuveau is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

If you have a planned surgery, tell your surgeon ahead of time about when you last received Jeuveau.

How is Jeuveau given?

Jeuveau should be given only by a trained medical professional, even when used for cosmetic purposes.

This medicine is injected into a muscle by a healthcare provider. Jeuveau injections should be spaced at least 3 months apart.

The effects of a Jeuveau injection are temporary. Your symptoms may return completely within 3 months. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Do not seek Jeuveau injections from more than one medical professional at a time. If you switch healthcare providers, tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

Dosing information

Usual Adult Dose for Glabellar Lines:

20 Units per treatment session divided into 5 equal IM injections of 4 Units each:
-Two injections in each corrugator muscle (one into inferomedial and one into superior middle)
-One injection in the procerus muscle

Retreatment should be administered no more frequently than every three months

Comments:
-The cumulative dose of botulinum toxin should be considered if other botulinum toxin products are or have been used for other indications.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Jeuveau?

This medicine may cause muscle weakness, vision problems, or dizziness. These effects can occur within hours or weeks after you receive a Jeuveau injection.

Avoid driving or hazardous activity until you know how this medicine will affect you.

Jeuveau side effects

Get emergency medical help if you have signs of an allergic reaction to Jeuveau: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Jeuveau can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• trouble breathing, talking, or swallowing;
• loss of bladder control;
• hoarse voice, drooping eyelids;
• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light); or
• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats.

Common Jeuveau side effects may include:

• headache;
• drooping eyelids;
• increased white blood cell counts; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

What is Jevtana?

Jevtana is a prescription cancer medicine that interferes with the growth and spread of cancer cells in the body.

Jevtana is used together with prednisone to treat prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to other parts of the body (metastatic).

Jevtana is usually given when the prostate cancer has worsened (progressed) after being previously treated with other medicines that included docetaxel as part of the treatment.

Warnings

You should not use Jevtana if you have severe liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80.

Jevtana affects your immune system. You may get infections more easily, even serious or fatal infections, especially if you are 65 or older. Call your doctor if you have a fever, muscle pain, cough, diarrhea, or pain or burning when you urinate.

Call your doctor right away if you have symptoms such as: fever, cough, body aches, easy bruising or bleeding, burning when you urinate, decreased urination, swelling in your hands or feet, severe stomach pain, constipation, blood in your urine or stools, or sudden chest pain and shortness of breath.

A serious allergic reaction may occur during the injection. Tell your caregivers right away if you have a rash or skin redness, chest tightness or trouble breathing, or if you feel like you might pass out.

Before taking this medicine

You should not use Jevtana if you are allergic to cabazitaxel, or if you have:

• severe liver disease;
• low white blood cell counts; or
• an allergy to any medicine that contains polysorbate 80.

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

• radiation treatment;
• liver or kidney disease;
• breathing problems; or
• a severe allergic reaction to any medication.

Although not for use by women, cabazitaxel can cause birth defects in a baby if the father is using this medicine.

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. Tell your doctor at once if a pregnancy occurs during this time.

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

How is Jevtana given?

Jevtana is given as an infusion into a vein. A healthcare provider will give you this injection.

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

Jevtana is usually given once every 3 weeks. You will be given other medications to prevent certain side effects.

You will most likely take prednisone (a steroid medicine) by mouth every day throughout your Jevtana treatment. Do not stop taking prednisone without your doctor’s advice, or you could have unpleasant side effects caused by Jevtana. Tell your doctor if you miss any doses or you stop taking prednisone for any reason.

Jevtana affects your immune system. You may get infections more easily, even serious or fatal infections, especially if you are 65 or older. Your doctor will need to examine you on a regular basis.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving Jevtana, which can lead to a serious electrolyte imbalance.

Your doctor may tell you to check your temperature at home throughout your treatment with Jevtana.

Dosing information

Usual Adult Dose for Prostate Cancer:

25 mg/m2 IV over 1 hour every three weeks

Comments:
-Use in combination with prednisone or prednisolone.
-Give premedication regimen at least 30 minutes prior to each administration.
-Give antiemetics prophylactically or as needed.
-Ensure adequate hydration throughout treatment.

Use: Use in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Jevtana injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe vomiting or diarrhea, fever, or worsening flu-like symptoms.

What should I avoid while receiving Jevtana?

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

Jevtana side effects

Jevtana can cause a serious allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Jevtana: hives, rash or skin redness; chest tightness or trouble breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Jevtana can cause serious or fatal side effects. Call your doctor at once if you have:

• numbness, burning pain, or tingly feeling in your hands or feet;
• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
• stomach pain or tenderness, severe vomiting or diarrhea, ongoing constipation;
• blood in your urine, urinating more often, pain or burning when you urinate;
• low blood cell counts – fever, chills, muscle pain, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of a kidney problem – little or no urinating; painful or difficult urination; swelling in your hands or feet; feeling tired or short of breath.

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

Some side effects may be more likely in older adults.

Common Jevtana side effects may include:

• fever, low blood cell counts;
• numbness or tingling;
• nausea, vomiting, stomach pain, loss of appetite;
• constipation, diarrhea;
• weakness, tired feeling;
• blood in your urine;
• back pain, joint pain;
• cough, shortness of breath;
• altered sense of taste; or
• hair loss.

Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Jinteli

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Jinteli

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Jinteli

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Jinteli

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Jinteli

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

What is Jolivette?

Jolivette is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Jolivette is used for birth control (contraception) to prevent pregnancy.

Jolivette is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of Jolivette are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

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

Jolivette 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.

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

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of Jolivette may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

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 Jolivette if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take Jolivette if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take Jolivette if you are nursing.

Before taking this medicine

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

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use Jolivette if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take Jolivette if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take Jolivette?

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

Carefully follow your doctor’s dosing instructions about when to start taking Jolivette for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take Jolivette for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take Jolivette for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take Jolivette for endometriosis: This medicine is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

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

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of Jolivette is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking Jolivette for contraception.

Jolivette will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect Jolivette?

Some drugs can make Jolivette less effective, which may result in unintended pregnancy if you use Jolivette for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

What is Jornay PM?

Jornay PM is a once-a-day capsule used to treat attention deficit hyperactivity disorder (ADHD). It contains a central nervous system (CNS) stimulant called methylphenidate hydrochloride.

It’s not known exactly how Jornay PM works in people with ADHD, but it is a stimulant that increases activity in the brain, especially in the areas that help regulate behavior and attention. It helps to boost the levels of dopamine and noradrenaline, which are chemical messengers (neurotransmitters), by preventing their re-uptake from the space between nerve cells (neurons) in the brain. Low levels of these chemical messengers have been found in people with ADHD.

Jornay PM is taken in the evening. Each capsule contains two layers. The outside layer is designed to delay the release of the drug so that it doesn’t start to be released until about 12 hours after it is taken. The inside layer extends the amount of time the drug is released into your body for. The two-layer approach is designed to help ensure Jornay PM is working when you wake up and keeps working during the day.

Medications containing methylphenidate, such as Jornay PM, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away Jornay PM may harm others, and is against the law.

Jornay PM was approved for use by the US Food and Drug Administration (FDA) in 2018, although methylphenidate in another formulation was first approved many years earlier in 1955.

What is Jornay PM used for?

Jornay PM is a prescription medicine used for the treatment of ADHD in people 6 years of age and older. It may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

It is not known if it is safe and effective in children under 6 years of age.

Important information

Jornay PM can cause serious side effects, including:

• Abuse and dependence. This medication contains methylphenidate. Jornay PM, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with this medication.
  • Tell your healthcare provider if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate
    
    Your healthcare provider should check you or your child carefully for heart problems before starting this medication. Tell your healthcare provider if you or your child has any heart problems, heart defects, or high blood pressure.
    
    Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with this medication.
    
    Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    
    Tell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.
    
    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Who should not take Jornay PM?

Do not take Jornay PM if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in Jornay PM. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my doctor before taking Jornay PM?

Before taking Jornay PM, tell your or your child’s healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes

How should I take Jornay PM?

• Take Jornay PM exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose and timing of the dose if needed.
• Take by mouth 1 time each day in the evening between 6:30 p.m. and 9:30 p.m.
• Take at the same time each evening. Jornay PM should not be taken in the morning.
• Take with or without food, but take it the same way each time.
• Jornay PM capsules may be swallowed whole, or if the capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto applesauce. Make sure to sprinkle all the contents of the capsule onto the applesauce. The dose should not be divided.
  • Swallow all the applesauce and medicine mixture right away
  • Do not chew the applesauce and medicine mixture
  • Do not store the applesauce and medicine mixture
• Your healthcare provider may sometimes stop treatment with this medication for a while to check for ADHD symptoms.

What happens if I miss a dose?

If a dose of Jornay PM is missed, it should be taken as soon as you remember the same evening. If you do not remember until the next morning you should not take the dose. Wait until that evening to take the next scheduled dose. A missed dose should not be taken in the morning.

What happens if I overdose?

If you or your child takes too much Jornay PM, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Jornay PM?

Avoid drinking alcohol during treatment with Jornay PM. This may cause a faster release of the medicine.

Dosing information

The recommended starting dose of Jornay PM for patients 6 years and over is 20 mg daily in the evening. The dose may be increased weekly in increments of 20 mg up to a maximum daily dose of 100 mg. Jornay PM should be taken between 6:30 pm and 9:30 pm. The timing of the dose can be adjusted within this window to help reduce side effects and ensure it is working when needed the following day.

See the Full Prescribing Information for further details about Jornay PM dosing.

What are the side effects of Jornay PM?

Jornay PM can cause serious side effects, including:

• See “Important information” above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, or painful
  • fingers or toes may change color from pale, to blue, to red
    
    Tell your healthcare provider if you or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
    
    Call your healthcare provider right away if you or your child has any signs of unexplained wounds appearing on fingers or toes during treatment with this medication.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

The most common side effects of methylphenidate products in children, adolescents, and adults with ADHD include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings (affect liability)
• increased heart rate
• increased blood pressure

The most common side effects of Jornay PM, in children age 6 to 12 with ADHD include:

• trouble sleeping
• decreased appetite
• restlessness (psychomotor hyperactivity)
• headache
• nausea
• mood swings
• vomiting

These are not all the possible side effects of this medication.

Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Jornay PM and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment.

Your healthcare provider will decide whether Jornay PM can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.

Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

What is Journavx?

Journavx (suzetrigine) is a new non-opioid pain-relieving tablet used to treat short-term (acute) moderate to severe pain. Journavx is a sodium channel blocker that relieves pain by blocking pain-sensing nerves around the body from transmitting pain messages to the spinal cord and brain. Since it does not affect the brain, is expected to have no addictive potential, unlike other pain treatments such as opioids.

Journavx’s mechanism of action is by selectively blocking NaV1.8, a sodium channel on pain-sensing nerve cells (neurons), this inhibits pain signals going to the spinal cord and brain. 

Journavx (suzetrigine) tablets are taken twice daily, every 12 hours after the first dose.

Journavx FDA approval was received on January 30, 2025, for treating moderate to severe acute pain in adults. This approval was based on positive results from Phase 3 clinical trials (VX21-548-101 and VX21-548-102), which showed that it effectively reduced acute pain for 48 hours after surgery.

How effective is Journavx?

In Phase 3 clinical trials, Journavx painkillers were more effective than a placebo in reducing pain and improving pain intensity for 48 hours after surgery (abdominoplasty and bunion removal). Pain levels were measured using the Numeric Pain Rating Scale (NPRS) and the Sum of Pain-Intensity Difference over 48 hours (SPID48). Higher SPID48 and NPRS values indicated greater pain relief. Results of clinical trials showed:

• Statistically and clinically meaningful improvements in pain intensity and pain reduction in baseline compared to placebo (an inactive pill).
• Abdominoplasty: Journavx 118.4 (LSM* SPID48) compared to 70.1 (LSM SPID48) placebo. The difference between Journavx and placebo was 48.4 (LSM SPID48)
• Bunion removal: Journavx 99.9 (LSM SPID48) compared to placebo 70.6 ((LSM SPID48). The difference between Journavx and placebo was 29.3 (LSM SPID48)
• The median time to meaningful pain relief was reported as 2 hours for abdominoplasty and 4 hours for bunion removal compared with 8 hours for placebo.

*LSM = Least squares mean

Journavx side effects

Journavx side effects include:

• Itching (2.1%) 
• Muscle spasms (1.3%)  
• Increased blood level of creatine phosphokinase (0.5%) 
• Rash (0.5%)

The above side effects occurred in 1% or more Journavx patients in Trials 1 and 2 (pooled data). 

Nausea and vomiting side effects 

• Journavx treated patients (20% Trial 1, 9% Trial 2)
• Placebo-treated patients (25% Trial 1, 12% Trial 2)

Fertility

• This medicine may temporarily reduce the chance of females becoming pregnant while taking this medicine. Talk to your healthcare provider if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with Journavx.
• Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx.
   

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

Liver impairment:

• These tablets should not be used if you have severe hepatic impairment ((Child-Pugh Class C).
• This medicine may increase the risk of side effects if you have moderate hepatic impairment (Child-Pugh Class B) compared to patients with normal liver function.

Strong inhibitors of CYP3A: 

• Journavx should not be taken with medicines that are strong inhibitors of CYP3A due to a drug interaction. Ask your healthcare provider or prescriber to check if you are not sure. 

Substrates of the CYP3A enzyme

• Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with Journavx and your prescriber may need to adjust the dose of your medicine when starting or stopping Journavx.

Contraception: 

• Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx. you should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during concomitant use and for 28 days after Journavx discontinuation.

Before taking this medicine

Before taking this medicine tell your doctor or prescriber about all of your medical conditions, including if you: 

• have liver problems. This medicine should not be used if you have severe liver impairment, or may cause side effects if you have moderate liver impairment. People with liver problems may have an increased risk of getting side effects from taking this medicine. 

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant as it is not known if this medicine will harm your unborn baby. You and your healthcare provider should decide if you will take these tablets while you are pregnant.

Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx. You should also use nonhormonal contraceptives such as condoms or other forms of hormonal birth control during treatment with this medicine and for 28 days after you stop taking Journavx.

Breastfeeding

 Tell your healthcare provider if you are breastfeeding or planning to breastfeed as it is not known if Journavx passes into your breast milk. You and your healthcare provider should decide if you will take this medicine while you are breastfeeding. 

How should I take Journavx?

• Swallow Journavx tablets whole, do not chew or crush the tablets. 
• Your first dose is usually 100mg taken on an empty stomach (1 hour before food or 2 hours after food). You may drink clear liquids during this time such as water, vegetable broth, tea, black coffee, or apple juice.
• The usual maintenance dose is 12 hours after your starting dose, take 50 mg tablet every 12 hours, with or without food.
• Your dose may be modified if you have liver impairment or if you are on certain medications
• It is best to use this medicine for the shortest possible time.

Journavx Dose information

Usual initial dose: 100mg on an empty stomach (1 hour before food or 2 hours after food).

Usual maintenance dose: 50mg every 12 hours, starting 12 hours after the initial dose.

Dose modification: according to liver impairment or medication interactions.

Journavx is available as: 50mg tablet.

What happens if I miss a dose?

 If you miss a dose of Journavx and you: 

• do not have liver problems or take certain other medicines:
  • Take the missed dose as soon as possible, then take your next scheduled dose at your recommended time.
  •  If you miss 2 or more doses of Journavx, take 2 tablets, then take your next scheduled dose at your recommended time. 
• have liver problems or are taking moderate inhibitors of an enzyme called CYP3A:
  • Take the missed dose as soon as possible.
  • If you took the missed dose and your next scheduled dose is within 6 hours, skip that dose and take your next scheduled dose at your recommended time.

If you are not sure about your dosing, check with your healthcare provider or pharmacist.

What happens if I overdose?

If you take too much of this medicine, call your healthcare provider or Poison Help line or go to the nearest hospital emergency room right away. 

What should I avoid while taking this medicine?

Avoid consuming food or drinks that contain grapefruit.

What other drugs will affect Journavx?

Tell your healthcare provider or prescriber about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Journavx with other medicines may affect how this medicine works and the way other medicines work, and may also increase your risk of side effects. 

Strong and Moderate CYP3A inhibitors: 

• Using Journavx with strong CYP3A inhibitors is contraindicated. 
• Reduce the Journavx dose when used concomitantly with moderate CYP3A inhibitors. 
• Avoid food or drink containing grapefruit. 

Strong and Moderate CYP3A inducers: 

• Avoid using this medicine with strong or moderate CYP3A inducers. 

CYP3A substrates:

• If Journavx is used together with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, then you should refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage modification of the concomitant CYP3A substrates may be required when initiating or discontinuing Journavx.

What is Jubbonti?

Jubbonti (denosumab-bbdz) is an injection that is administered subcutaneously (under the skin) once every 6 months by a healthcare provider to:

• Treat osteoporosis in postmenopausal women at high risk for fracture
• Increase bone mass in men with osteoporosis at high risk for fracture
• Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Bone is always breaking down and reforming. Everyone has osteoclasts that dissolve old and damaged bone and osteoblasts that form new bones and add growth to existing bone tissue. Jubbonti works by stopping the formation of osteoclasts before they can reach and damage the bone. It binds to RANKL, a protein on the membrane of osteoclasts essential for their formation, function, and survival. This inhibits osteoclast formation, decreasing bone resorption and increasing bone mass and strength in both cortical (hard bone) and trabecular (spongy bone). Jubbonti is a monoclonal antibody that targets and inhibits RANK ligand (RANKL).

Jubbonti is an interchangeable biosimilar to Prolia (denosumab) and was FDA-approved on March 5, 2024. An interchangeable biosimilar is a biological product that can be substituted in the pharmacy for the reference biologic because there are no clinically meaningful differences in safety, purity, and potency.

Warnings

Jubbonti carries a boxed warning for life-threatening severe hypocalcemia (very low calcium levels); the risk is higher in patients with advanced chronic kidney disease (CKD), particularly those on dialysis. The risk increases even more in those with CKD who also have a condition known as mineral and bone disorder (CKD-MBD). Your healthcare provider will evaluate you for hypocalcemia and CKD-MBD before starting treatment and monitor you throughout. Pre-existing low calcium levels should be corrected before starting treatment.

If you receive Jubbonti, you should not receive Prolia, Xgeva, or Wyost. Jubbonti contains the same medicine (denosumab).

Serious and life-threatening hypersensitivity reactions have occurred with Jubbonti, including anaphylaxis. Seek emergency help or tell your doctor immediately if you experience shortness of breath, throat tightness, swelling of the airways and throat, itching, low blood pressure, or hives.

Osteonecrosis of the jaw has been reported with Jubbonti. A routine oral exam should be performed before Jubbonti treatment and preventive dentistry undertaken if necessary, especially for those with risk factors such as prior tooth extraction, dental implants, oral surgery, cancer, or poor oral hygiene. Good oral hygiene practices should be maintained during treatment with Jubbonti.

Atypical low energy or low trauma femoral fractures have been reported with Jubbonti. Contact your doctor immediately if you develop thigh or groin pain. Multiple vertebral fractures have been reported following Jubbonti discontinuation. Your healthcare provider should consider transitioning you to another antiresorptive agent.

Serious infections including skin infections may occur, including those leading to hospitalization. Seek emergency help or tell your healthcare provider immediately if you develop any signs or symptoms of an infection, including cellulitis (symptoms include a red, swollen, and painful area of skin that is warm and tender to the touch. Some people may also develop fever and chills).

Other severe side effects including severe skin rashes and eczema, bone over-suppression, or severe bone, joint, or muscle pain may occur. Tell your healthcare provider immediately.

Before taking

Tell your doctor about all of your medical conditions, including if you:

• are allergic to denosumab or latex
• are taking a medicine called Xgeva (denosumab). Xgeva contains the same medicine as Jubbonti
• have low blood calcium
• cannot take daily calcium and vitamin D
• had parathyroid or thyroid surgery (glands located in your neck) or intestinal surgery
• have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• have kidney problems or are on kidney dialysis
• have a weak immune system
• are taking medicine that can lower your blood calcium levels
• plan to have dental surgery or teeth removed
• are pregnant or plan to become pregnant. Jubbonti may harm your unborn baby
• are breastfeeding or plan to breastfeed.

Pregnancy

For females who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Jubbonti. You should use an effective method of birth control (contraception) during treatment with Jubbonti and for at least 5 months after your last dose. Tell your doctor right away if you inadvertently become pregnant.

Breastfeeding

It is not known if Jubbonti passes into your breast milk. You and your doctor should decide if you will take Jubbonti or breastfeed. You should not do both.

How is Jubbonti administered?

Jubbonti is an injection that will be given to you by a healthcare professional. Jubbonti is injected under your skin (subcutaneously).

• You will receive Jubbonti 1 time every 6 months.
• You should take calcium and vitamin D as your doctor tells you to while you receive Jubbonti.
• Take good care of your teeth and gums while you receive Jubbonti. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Jubbonti. You may need to stop using the medicine for a short time.

Talk with your doctor before starting Jubbonti treatment. After your treatment with Jubbonti is stopped, or if you skip or delay taking a dose, your risk of breaking bones, including bones in your spine, is increased. Your risk of having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip, or delay taking Jubbonti without first talking with your doctor. If your Jubbonti treatment is stopped, talk to your doctor about other medicines that you can take.

• Your risk of bone fractures can increase when you stop, skip, or delay using Jubbonti. Do not stop using this medicine without first talking to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose or miss an appointment for your Jubbonti injection. You should receive your missed injection as soon as possible.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What are the side effects of Jubbonti?

Serious allergic reactions have happened in people who take Jubbonti. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction such as low blood pressure (hypotension), trouble breathing, throat tightness, swelling of your face, lips, or tongue, rash, itching, or hives.

Jubbonti can cause serious side effects including:

• Increased risk of severe low calcium levels in your blood (hypocalcemia). Jubbonti may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Jubbonti, it may get worse during treatment. Your low blood calcium must be treated before you receive Jubbonti. Talk to your doctor before starting Jubbonti. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Jubbonti. Take calcium and vitamin D as your doctor tells you to. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes, or around your mouth
• Severe jaw bone problems (osteonecrosis). Your doctor should examine your mouth before you start Jubbonti. Your doctor may tell you to see your dentist before you start Jubbonti. You need to practice good mouth care during treatment with Jubbonti
• Unusual thigh bone fractures. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh
• Increased risk of broken bones, including broken bones in the spine, after stopping, skipping, or delaying Jubbonti
• Serious infections in your skin, lower stomach area (abdomen), bladder, ear, or heart. You may need to go to the hospital for treatment if you develop an infection. Call your doctor right away if you develop:
  • fever or chills
  • skin that looks red or swollen and is hot or tender to touch
  • shortness of breath, cough that will not go away
  • severe abdominal pain
  • frequent or urgent need to urinate or a burning feeling when you urinate
• Skin problems such as inflammation of your skin (dermatitis), rash, and eczema. Call your doctor if you have any of the following symptoms that do not go away or get worse: redness, itching, small bumps or patches (rash), your skin is dry or feels like leather, blisters that ooze or become crusty, skin peeling
• Bone, joint, or muscle pain.

Common Jubbonti side effects may include:

pain in your arms or legs.

bladder infection (painful or difficult urination)

lung infection (cough, shortness of breath)

headache

back pain, muscle or joint pain

increased blood pressure

cold symptoms such as stuffy nose, sneezing, sore throat

high cholesterol or

What is Jublia solution?
Jublia topical solution contains efinaconazole, an antifungal medication that fights infections caused by fungus.

Jublia solution is used to treat a fungal infection of the toenail called onychomycosis.

Jublia solution is a clear, colorless to pale yellow solution supplied in a white plastic bottle with a flow-through brush applicator.

Warnings
Jublia solution is for external use only and is not for ophthalmic, oral, or intravaginal use. It is for use on toenails and immediately adjacent skin only.

Avoid pedicures, the use of nail polish, and cosmetic nail products while using Jublia.

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 Jublia if you are allergic to efinaconazole.

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

It is not known whether efinaconazole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Jublia solution is not approved for use by anyone younger than 6 years old.

Jublia pregnancy and breastfeeding warnings (more detail)
How should I use Jublia solution?
Use Jublia solution 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.

Jublia is usually applied to affected toenails once daily for 48 weeks (approximately 11 months).

Before you apply this medicine, wash and thoroughly dry your toenails. Wait at least 10 minutes after showering, bathing, or washing the area before applying Jublia.

Apply this medicine over the entire toenail and under the tip of the nail. Allow the medicine to dry completely before putting on a sock or shoe.

After you apply Jublia solution, wait at least 10 minutes before you take a bath or shower.

Avoid getting this medicine on any other skin besides the cuticles or the skin around your toenail.

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

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses can increase your risk of infection that is resistant to medication.

Store in an upright position at room temperature, away from moisture and heat. Do not freeze.

Store in an upright position at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use. Do not freeze.

Jublia solution is flammable. Do not use near high heat or open flame. Do not smoke until the solution has completely dried on your nail.

Dosing information
Usual Adult Dose for Onychomycosis — Toenail:

Apply to affected toenail(s) once a day for 48 weeks.

Comments:
-The integrated flow-through brush applicator should be used.
-The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

Use: For the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and T mentagrophytes

Usual Pediatric Dose for Onychomycosis — Toenail:

6 years or older: Apply to affected toenail(s) once a day for 48 weeks.

Comments:
-The integrated flow-through brush applicator should be used.
-The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

Use: For the topical treatment of onychomycosis of the toenail(s) due to T rubrum and T mentagrophytes

Detailed Jublia dosage information
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?
An overdose of Jublia solution is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using Jublia?
Do not get this medicine in your eyes, mouth, or vagina. Jublia solution is for use only on the toenails.

Avoid having a pedicure or using nail polish on your toenails.

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

Call your doctor at once if you have:

severe redness, itching, or swelling of the affected toenail.

Common Jublia side effects may include:

pain, redness, swelling, burning, stinging, itching, or blisters where the medicine was applied; or

ingrown toenail.

Use

The seeds, fruit, and bark of jujube have been used in traditional medicine for anxiety and insomnia, and as an appetite stimulant or digestive aid. Experiments in humans and animals support the presence of anxiolytic and sedative properties. However, robust evidence from epidemiologic and clinical studies is lacking.

Dosing

Information is lacking.

Contraindications

Information is lacking.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. Avoid use of jujube bark preparations.

Interactions

An interaction with venlafaxine has been reported.

Adverse Reactions

Information is lacking.

Toxicology

Information is lacking.

Scientific Family

• Rhamnaceae (Buckthorn)

Botany

Z. jujuba is a small deciduous tree or shrub with thorny branches that grows 5 to 10 m tall. It is native to many parts of Asia, requiring hot summers and sufficient water for fruiting; however, the plant can tolerate colder temperatures and can survive in desert habitats. It has 2 to 7 cm long shiny, green, ovate leaves with 3 conspicuous veins at the base of the leaves. The flowers are small with yellow-green petals. The edible oval fruits are green when immature, turn dark red to purple-black and wrinkle when ripe, and contain a single hard seed.

History

Traditional use of jujube dates back 2,500 years in original Chinese materia medica records. The fruit, seed, and bark are described in Korean, Indian, and Japanese traditional writings, as well. They are used to alleviate stress and insomnia and as appetite stimulants, digestive aids, antiarrhythmics, and contraceptives. The sweet smell of the fruit is said to make teenagers fall in love. The fruit is eaten fresh or dried and made into candy; tea, syrup, and wine are also made from the berries. This traditional Chinese medicine has been used to treat many diseases such as insomnia, forgetfulness, headaches, and dizziness.

Chemistry

Over 150 compounds have been identified in this plant, including terpenoids, alkaloids, flavonoids, fatty acids, volatile oils, polysaccharides, and others.The polysaccharides are one of the major biologically active components of the jujube fruit and have various biological effects, including immunomodulatory, antioxidant, antitumor, hepatoprotective, and hypoglycemic activities, and GI-protective effects.

Composition of the plant parts varies geographically, as well as on the processing technique used. The fruit is high in carbohydrates, especially fructose and glucose, which accounts for about 77% of the weight. Vitamins C, B complex, and A, as well as calcium, potassium, and other mineral elements, have been identified.

Glycoside saponins, including jujuboside A and B, have been identified, as well as flavonoids, triterpenes, and short-medium chain fatty acids (eg, stearic, oleic, palmitic, linoleic).

Uses and Pharmacology

Both extracts and purified compounds have excellent biological activities, especially sedative and hypnotic effects. Other effects include ameliorating or improving learning and memory, anti-inflammation, antioxidation, blood pressure and lipid lowering, antiaging, and antitumor effects.

Anemia

Evidence for the development of jujube fruit as a supplementary product for prevention and/or treatment of anemia has been proposed. In addition, further investigation, production, and application of jujube polysaccharides in functional foods and therapeutic agents is foreseen.

CNS

Animal data

Jujube is used traditionally as an anxiolytic and sedative. Animal experiments using the saponin jujuboside and flavonoids from the fruits, as well as the seed extract, showed reductions in anxiety, impaired coordination and responses, and enhanced barbiturate-induced hypnotic effects.

In a plant screening exercise, oleamide from a jujube extract given for 3 weeks attenuated scopolamine-induced amnesia in mice. A role in cognitive impairment disorders, such as that seen in Alzheimer disease, was suggested, as the jujube extract appeared to increase the activation of choline acetyltransferase.

A hydroalcoholic extract of Z. jujube has been shown to possess antiepileptic effects against induced seizures in rodents.

Clinical data

A role in the management of insomnia has been suggested in a review of pharmacological effects of the jujube seed, based on 2 small clinical studies.The chemistry and psychopharmacology of the seeds of the Z. jujuba plant, Ziziphus spinosa, has been reported. Whole extracts and constituent compounds have been evaluated in preclinical and clinical studies. Z. spinosa secondary metabolites have shown to modulate GABAergic activity and the serotonergic system. The actual therapeutic agents require further confirmation/identification so that new insomnia phytomedicines can be discovered.(Shergis 2017)

A systematic review and meta-analysis of traditional herbal medicine (with Z. jujuba as the most frequently used herb) concluded that traditional herbal medicine may be an effective therapeutic option for insomnia in patients with cancer. However, considering the limited methodological qualities and inconsistent results of the included trials, further rigorous randomized controlled trials are required.

Cancer

Animal and in vitro data

Ursonic acid (UNA) is a naturally occurring pentacyclic triterpenoid extracted from certain medicinal herbs such as Z. jujuba. UNA has promising potential to be developed into cancer- and protozoan-fighting pharmaceuticals.

Studies using specific saponins, as well as ethyl acetate and water extracts of the fruit and bark, have explored the potential cytotoxicity of jujube. Apoptosis and differential cell cycle arrest are suggested to be responsible for the dose-dependent reduction in cell viability. Activity against certain human cancer cell lines has been demonstrated in vitro.

Contraceptive

An ethyl acetate extract of the plant bark had a contraceptive effect, as it arrested the normal estrus cycle of adult female mice and reduced the weight of the ovaries. The antisteroid action was reversed upon cessation of the extract supplementation.

Drug-induced hepatotoxicity

A small pilot, randomized, double-blind, placebo-controlled, clinical trial investigated the efficacy of Jujube syrup on the prevention of drug-induced hepatotoxicity in pulmonary tuberculosis (TB) patients. This study suggested that jujube syrup could prevent anti-TB drug-induced hepatotoxicity and that it could also improve the severity of the patient’s cough as well as the quality of life in pulmonary TB patients.

Gastrointestinal/Dyslipidemia

Animal data

Jujube fruit has traditionally been used as a paste, puree, or soup to enhance digestion. In animal experiments, jujube extract decreased GI transit time and increased fecal moisture content. Increased fatty acid concentration in the cecum and decreased fecal ammonia and bacterial enzyme activity in the feces were also measured.

Clinical data

In a small (N = 50) clinical trial, the symptoms of patients with chronic idiopathic constipation improved with daily consumption of jujube extract (average, 20 drops per day) versus placebo. Because of practical issues, GI transit times were not measured in the study. Jujube extract may offer a safe natural laxative option.

A clinical study evaluated consumption of jujube fruit as a powder (5 g taken 3 times a day for 1 month) among 86 obese adolescents (12 to 18 years of age) with dyslipidemia. Decreased serum total cholesterol and LDL cholesterol were reported, with no effect on other lipid indices, blood glucose, or BMI.

Immunoregulatory

In vitro experiments in sheep and human blood suggest anticomplementary action of the tripenoids of ethylacetate fruit extracts.(Lee 2004, Chan 2005)

Z. jujube (3.9%) is an ingredient in the Chinese multi-preparation CKBM-A01 studied for immunological effect.

Dosing

Information on dosages for clinical applications is lacking. Bacterial contamination of imported jujube products remains an issue for the Food and Drug Administration (FDA).

In a clinical trial, up to 40 drops/day of extract were used in chronic idiopathic constipation. For traditional GI uses, up to 50 g/day of dried fruit (equivalent to 4 g of extract) has been used.) A clinical study evaluated consumption of 5 g powdered jujube fruit taken 3 times/day for 1 month in adolescents with dyslipidemia. Doses of 10 mL/day of jujube syrup have also been used in a study evaluating drug-induced hepatotoxicity.(Maddahi 2022)

Pregnancy / Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. A contraceptive action of a bark extract has been demonstrated in mice.

Interactions

There has been a case report of a severe, acute serotonin reaction of venlafaxine with coadministration of jujube. Jujube 0.5 g/day was consumed regularly, and the reaction occurred after a single dose of venlafaxine 37.5 mg.

Potentiation of effect of phenytoin and phenobarbitone in rodents has been reported. No effect on carbamazepine was noted

Adverse Reactions

Information is lacking. A clinical trial using extract of jujube reported no adverse effects and no changes to liver or kidney laboratory indices. Immunoglobulin E–mediated allergy with angioedema, generalized urticaria, asthma, and hypotension has been reported. A cross-reactivity with latex is also suggested.

What is Juluca?

Juluca contains a combination of dolutegravir and rilpivirine. Dolutegravir and rilpivirine are antiviral medicines that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Juluca is used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS).

Juluca is not a cure for HIV or AIDS.

Juluca is for use only in people who have been successfully treated with other antiviral medications for at least 6 months.

Warnings

Taking Juluca during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using dolutegravir.

Before taking this medicine

You should not use Juluca if you are allergic to dolutegravir or rilpivirine.

Some medicines can cause unwanted or dangerous effects when used with Juluca. Your doctor may need to change your treatment plan if you also use:

• dofetilide (can cause serious medical problems or death when taken with Juluca);
• St John’s wort;
• more than one dose of dexamethasone;
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;
• rifampin, rifapentine; or
• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

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

• liver problems;
• mental illness;
• a severe skin rash or allergic reaction to dolutegravir or rilpivirine; or
• if you also take rifabutin.

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

Juluca may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

HIV can be passed to your baby if the virus is not controlled during pregnancy. If you are pregnant, your name may be listed on a registry to track any effects of antiviral medicine on the baby. Use your medications properly to control HIV.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Juluca?

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

Always take this medicine with food, not with a meal replacement drink.

You will need frequent blood tests.

Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Get your prescription refilled before you run out of medicine completely.

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

Dosing information

Usual Adult Dose of Juluca for HIV Infection:

1 tablet orally once a day with a meal

Use: As a complete regimen for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components

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 .

Juluca side effects

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Juluca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Call your doctor at once if you have:

• thoughts about suicide or hurting yourself;
• anxiety, sadness, feeling hopeless;
• depression – mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or
• liver problems – nausea, vomiting, loss of appetite, right-sided upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir and rilpivirine affects your immune system, which may cause certain side effects (even weeks or months after you’ve taken this medicine). Tell your doctor if you have:

• signs of a new infection – fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Juluca side effects may include:

• headache; or
• nausea, diarrhea.

Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Junel 1.5/30

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Junel 1.5/30

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Junel 1.5/30

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Junel 1.5/30

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Junel 1.5/30

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Commonly used brand name(s)

In the U.S.

• Femhrt 1/5
• Femhrt Lo
• Gildess 1.5/30
• Jevantique
• Jinteli
• Junel 1/20
• Junel 1.5/30
• Larin 1/20
• Loestrin 1/20
• Loestrin 1.5/30
• Microgestin 1/20
• Microgestin 1.5/30

Available Dosage Forms:

• Tablet, Chewable
• Tablet
• Capsule, Liquid Filled

Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Junel 1/20

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Junel 1/20

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Junel 1/20

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Junel 1/20

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Junel 1/20

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

What is Juvederm?

Juvederm is a family of injectable hyaluronic acid dermal fillers used to provide 9 months to one year of correction for moderate to severe facial wrinkles and folds, such as nasolabial folds (lines from the nose to the corners of the mouth). It is also used for lip augmentation.

Juvederm products are a smooth consistency gel, compared to some hyaluronic gel products that have a granular consistency. Juvederm products are developed using the Hylacross technology to allow a smoother, malleable gel. Hyaluronic acid is a naturally occurring sugar found in the body. Hyaluronic acid works by holding in water at the injection site and acting as a cushioning agent. It adds temporary volume and a smoother appearance to skin. Most patients need more than one treatment to achieve optimal results.

Juvederm XC products also contain the local anesthetic lidocaine for a more comfortable injection as this numbs the treatment area within seconds. The Juvederm Ultra XC products contain more highly cross-linked formulations for volumizing and correction of deeper folds and wrinkles.

The Juvederm range of products are designed to meet specific needs depending on the area of the face being treated and increase in volume required.

• Juvederm Voluma® XC is used for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile.
• Juvederm Vollure XC is used for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
• Juvederm ® Ultra Plus XC is used for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
• Juvederm® Ultra XC is is used for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also used for injection into the lips and perioral area for lip augmentation.
• Juvederm® XC Is suitable for moderate or severe facial folds or wrinkles such as the fold that runs from your nose to mouth (parentheses lines).
• Juvederm Volbella® XC is used for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows.
• Juvederm Volux XC injectable gel is used for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.

Instructions for use for Juvederm

How painful are Juvederm injections?

There may be some discomfort during and after the injection. Juvederm is injected directly into the skin with a fine needle. Juvederm products contain the local anesthetic lidocaine to help lessen discomfort during injection, or the physician may choose to numb the site prior to injection. You should discuss these options with your physician prior to the procedure.

What is expected after the procedure?

Within the first 24 hours, avoid:

• strenuous exercise
• extensive sun or heat exposure
• alcoholic beverages

Exposure to any of the above may lead to temporary redness, swelling, and/or itching at the injection site. If swelling occurs, place an ice pack over the swollen area. Ask the physician how long to wait until make-up can be re-applied after the procedure.

How long does the Juvederm correction last?

Correction with Juvederm is temporary. Re-injections may be needed, typically between 9 months and one year after the initial injection. Smaller injections (about half the amount) are needed for repeat procedures.

What other treatments are available for correction of facial wrinkles and folds?

• Bovine-based collagen
• Other hyaluronic acid-based dermal fillers
• Facial Creams
• Botox (botulinum toxin type A)
• Chemical peels
• Laser skin surface treatments

Juvederm Clinical Trials

In the two primary U.S. clinical studies evaluating Juvederm Ultra or Juvederm Ultra Plus for safety and effectiveness, roughly 145 subjects were followed for 24 weeks after the Juvederm injection in one nasolabial fold. Compared to Zyplast dermal filler (bovine-based collagen) which was injected into the opposite nasolabial fold, Juvederm injection site reactions were similar in duration and frequency, mild to moderate in severity, did not require intervention, and typically lasted about 7 days. Redness, pain/tenderness, firmness, swelling and lumps/bumps occurred in roughly 80-90% of patients, bruising in 60% of patients, and itching and discoloration in roughly 35% of patients.

The percent of patients who maintained improvement with Juvederm at 24 weeks was 88-90% compared to 36-40% with Zyplast. At study end, 84-88% of the patients expressed a preference for Juvederm Ultra injectable gel, 5-10% had a preference for Zyplast, and 5-6% of patients had no preference.

Of 146 subjects, 111-116 (76-79%) returned for a complimentary repeat treatment at an average of 36 weeks after their last injection. Forty-eight subjects returned after 36 weeks. Subjects who maintained improvement with Juvederm Ultra injectable gel was 75-81%. Patients rated their improvement prior to injection as mainly mild to moderate (between 1 and 2 on a scale going from 0 [no improvement] to 4 [extreme improvement]) from 2 weeks until greater than 36 weeks after injection.

Important Safety Information

Contraindications: Juvederm injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or a history or presence of multiple severe allergies. Juvederm should not be used in patients with a history of allergies to Gram-positive bacterial proteins. Juvederm Ultra XC and Juvederm Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.

Warnings: Juvederm injectable gel should not be injected into blood vessels as this can cause blood vessel blockage which may result in skin tissue dying, vision impairment (temporary or permanent), and even stroke. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.

Precautions: Juvederm should only be administered under the supervision of a licensed health care practitioner.

• Patients should inform their physician if they are using substances that may prolong bleeding or bruising, such as aspirin, or ibuprofen, or naproxen.
• Inflammation may occur at the treatment site if laser treatment, chemical peeling, or any other dermal procedure is performed after Juvederm treatment.
• Use with caution in patients on immunosuppressive therapy due to the possibility of increased infection risk.
• Safety for use during pregnancy, in breastfeeding, or in patients under 18 years has not been established.
• Safety in patients with excessive scarring (e.g., hypertrophic scarring or keloid formation) and pigmentation disorders has not been studied.

What are the Side Effects of Juvederm?

Juvederm Side Effects: Most Juvederm side effects are mild in nature and short-lived, usually resolving in 7 days or less. The most common side effects include injections site reactions, such as:

• Redness
• Pain/tenderness
• Firmness
• Swelling
• Lumps/bumps
• Bruising
• Itching
• Discoloration
• Risk of infection