What is Kadcyla?

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

Kadcyla is used to treat HER2-positive breast cancer.

Kadcyla is used both for early breast cancer and for breast cancer that has spread to other parts of the body (metastatic).

Kadcyla is usually given after other cancer medications have been tried without success.

Kadcyla should not be used in place of Herceptin (trastuzumab).

Warnings

Do not use Kadcyla if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

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

Kadcyla can harm your liver. Call your doctor at once if you have upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before you receive each Kadcyla injection, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Before taking this medicine

You should not use Kadcyla if you are allergic to ado-trastuzumab emtansine.

Do not use Kadcyla if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose.

Tell your doctor if you become pregnant during treatment.

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

• heart problems;
• liver disease (especially hepatitis B or C);
• bleeding or blood clotting disorder such as hemophilia; or
• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder.

You should not breast-feed while using this medicine.

How is Kadcyla given?

Kadcyla 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 30 to 90 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Kadcyla is injected.

Kadcyla is usually given once every 3 weeks. Your doctor will determine how long to treat you.

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

Dosing information

Usual Adult Dose for Breast Cancer:

3.6 mg/kg IV every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
Maximum dose: 3.6 mg/kg IV every 3 weeks

Comments:
-Administer the first infusion over 90 minutes. Subsequent infusions may be administered over 30 minutes as tolerated.
-Observe patients during and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions.
-Patients should have a HER2 positive tumor status confirmed prior to starting therapy.
-Do not substitute trastuzumab emtansine for or with trastuzumab.
-If a planned dose is delayed or missed, it should be administered as soon as possible; do not wait until the next planned cycle.

Use: As a single agent, for HER2-positive, metastatic breast cancer in patients who previously received trastuzumab and a taxane, separately or in combination; patients should have either:
-Received prior therapy for metastatic disease
OR
-Developed disease recurrence during or within 6 months of completing adjuvant therapy

What happens if I miss a dose?

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

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What to avoid

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

Ado-trastuzumab emtansine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Kadcyla side effects

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

Some side effects may occur during the injection. Tell your caregiver right away if you feel cold, light-headed, feverish or sweaty, or have chest tightness, rapid heartbeats, or trouble breathing.

Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;
• coughing up blood or vomit that looks like coffee grounds;
• bloody or tarry stools;
• chest pain, wheezing, dry cough, feeling short of breath;
• unusual tiredness, feeling light-headed;
• pale skin, cold hands and feet;
• numbness, tingling, or burning pain in your hands or feet;
• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• liver problems – loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of tumor cell breakdown – confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

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

Common Kadcyla side effects may include:

• easy bruising or bleeding (especially nosebleeds);
• nausea, constipation;
• joint or muscle pain;
• headache; or
• feeling tired.

What is Kadian?

Kadian is an extended-release prescription pain medicine that is used to manage pain severe enough to require daily around-the-clock, long-term treatment.

Kadian belongs to a class of medications called opiate (narcotic) analgesics. Morphine works by changing the way the brain and nervous system respond to pain.

Kadian is used when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Kadian extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed.

Kadian side effects

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

Opioid medicine can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• chest pain, fast or pounding heartbeats;
• extreme drowsiness, feeling like you might pass out; or
• decreased adrenal gland hormones – nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Kadian side effects may include:

• drowsiness, dizziness, tiredness, anxiety;
• nausea, vomiting, stomach pain, gas, or constipation;
• sweating, low oxygen levels (shortness of breath), feeling light-headed; or
• feelings of extreme happiness or sadness.

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 Kadian if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or a bowel obstruction called paralytic ileus.

Morphine can slow or stop your breathing, and may be habit-forming MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, , especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Kadian with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not take Kadian capsules if you have ever had an allergic reaction to morphine or other opioid medicines, or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus); or
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

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

• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a head injury, brain tumor, high pressure inside the skull, or seizures;
• a drug or alcohol addiction, or mental illness;
• urination problems;
• problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland; or
• liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with morphine could cause a serious condition called serotonin syndrome.

Morphine may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use morphine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Long-term Kadian use may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using Kadian.

Do not breastfeed. Morphine in breast milk can cause life-threatening side effects in a nursing baby.

How should I take Kadian?

Take Kadian exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Kadian in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more Kadian.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away Kadian is against the law.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

Swallow the Kadian extended release capsule whole to avoid exsure to a potentially fatal overdose. Do not crush, chew, or dissolve.

If you cannot swallow a Kadian capsule whole, you can open the capsule and mix the medicine with applesauce. Open the capsule and sprinkle the pellets over about one tablespoon of applesauce. Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose. Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets. Flush the empty capsule down the toilet right away.

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

You should not stop using Kadian suddenly. Stopping suddenly may cause withdrawal symptoms. Ask your doctor before stopping the medicine.

Your dose needs may change if you switch to a different brand, strength, or form of morphine. Avoid medication errors by using only the medicine your doctor prescribes.

Do not keep leftover medicine. Just one dose can cause death in someone using Kadian accidentally or improperly. Ask your pharmacist about a drug take-back program,or flush the unused medicine down the toilet.

Store tightly closed at room temperature, away from moisture, heat and light. Keep your medicine in a place where no one can use it improperly.

What happens if I miss a dose?

Since Kadian is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking Kadian?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Kadian will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What is Kapvay?

Kapvay is a prescription medicine supplied as an extended-release tablet and is used to treat attention deficit hyperactivity disorder (ADHD).

Your doctor may prescribe Kapvay alone or together with certain other ADHD medicines.

Kapvay is not a central nervous system (CNS) stimulant.

Kapvay should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

Warnings

Use Kapvay only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before you take Kapvay, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

Before taking this medicine

You should not take Kapvay if you are allergic to clonidine.

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

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

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

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Do not give Kapvay to a child younger than 6 years old.

How should I take Kapvay?

Take Kapvay 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.

Kapvay is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Kapvay may be taken with or without food.

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

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using Kapvay suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. Prolonged illness can make it harder for your body to absorb clonidine, which may lead to withdrawal symptoms. This is especially important for a child taking Kapvay.

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

Dosing information

Usual Pediatric Dose for Attention Deficit Disorder:

Extended release:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

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 .

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

What should I avoid while taking Kapvay?

Avoid drinking alcohol. It may increase certain side effects of Kapvay.

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

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Kapvay side effects

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

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Common Kapvay side effects may include:

• drowsiness, dizziness;
• feeling tired or irritable;
• dry mouth;
• constipation, loss of appetite; or
• sleep problems (insomnia), nightmares.

• Piper methysticum
• Ava
• Ava Pepper
• Ava Root
• Awa
• Gea
• Gi
• Intoxicating Long Pepper
• Intoxicating Pepper
• Kao
• Kava Kava
• Kava Pepper
• Kava Root
• Kava-kava
• Kavain
• Kawa
• Kawa Kawa
• Kawa Pepper
• Kawain
• Kew
• Long Pepper
• Rauschpfeffer
• Sakau
• Tonga
• Wurzelstock
• Yangona
• Yaqona
• Yaquon
• Yongona

What is this product used for?

Kava may help lower anxiety in some people.

What are the precautions when taking this product?

• Always check with your doctor before you use a natural product. Some products may not mix well with drugs or other natural products.
• Be sure to tell your doctor that you take this product if you are scheduled for surgery or tests.
• Do not use this product if you are pregnant or plan to become pregnant soon. Use birth control you can trust while taking this product.
• Do not breastfeed while using this product.
• Do not use in children.
• Avoid beer, wine, and mixed drinks (alcohol) while taking this product.
• This product may cause you to be sleepy. Take extra care driving and doing tasks that you need to be alert for.
• Take extra care if you are taking drugs that make you drowsy or help you sleep. These are drugs like lorazepam, phenobarbital, zolpidem, or diphenhydramine.
• Take extra care if you are taking drugs that affect dopamine levels. These are drugs like levodopa-carbidopa, ropinirole, and pramipexole.
• Take extra care if you are taking drugs called MAO inhibitors. These are drugs like isocarboxazid, phenelzine, and tranylcypromine.
• Take extra care if you are taking drugs to help with swelling or inflammation. These may increase your risk of bleeding. These are drugs like nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, ibuprofen, or naproxen.
• Take extra care and check with your doctor if you have:
  • Kidney problems
  • Liver problems
  • Blood disorders
  • Parkinson’s disease
  • Low mood
  • Heart problems
  • Insomnia or problems sleeping

What should I watch for?

• Upset stomach
• Eye irritation or problems seeing
• Loss of balance or problems walking
• Mouth numbness
• Scaly rash

When do I need to call the doctor?

• Signs of a very bad reaction. These include wheezing; chest tightness; trouble breathing, swallowing, or talking; fever; rash; hives; itching, discolored, swollen, blistered, or peeling skin; or swelling of face, lips, tongue, or throat. Go to the ER right away.
• Signs of liver problems. These include upset stomach or throwing up, belly pain, feeling tired, dark urine, yellow skin or eyes, not hungry.
• Signs of muscle damage. These include bad muscle aches, reddish color of urine, decreased amount of urine, and weakness.
• Very bad throwing up
• Very bad belly pain
• Very bad loose stools
• Very bad headache
• Too tired or sleepy
• Change in your ability to think clearly

Last Reviewed Date

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. 

What is Kayexalate?

Kayexalate binds itself to potassium in your digestive tract. This helps prevent your body from absorbing too much potassium.

Kayexalate is used to treat high levels of potassium in the blood, also called hyperkalemia.

Kayexalate works differently from other medicines because it passes into your intestines without being absorbed into your blood stream.

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

Kayexalate 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.

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

• stomach pain, rectal pain;
• severe constipation, severe stomach pain, bloating;
• fever, chills, vomiting;
• confusion, thinking problems, feeling irritable;
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• low calcium levels–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes); or
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Kayexalate may include:

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

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 Kayexalate if you have low potassium levels or a bowel obstruction.

Do not give this medicine orally (by mouth) to a newborn baby.

Avoid taking other medicines by mouth within 3 hours before or 3 hours after you take Kayexalate (or 6 hours before/after if you have slow digestion).

Before taking this medicine

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

• low potassium levels (hypokalemia); or
• a bowel obstruction.

Tell your doctor if you have ever had:

• heart disease or high blood pressure;
• a weak immune system caused using certain medicine;
• severe constipation or other bowel problems;
• kidney disease (or if you are on dialysis);
• an electrolyte imbalance (such as low levels of potassium, calcium, or magnesium in your blood);
• fluid retention;
• severe burns;
• a bowel disorder, or surgery on your intestines;
• if you are dehydrated; or
• if you are on a low-salt diet.

Because Kayexalate is not absorbed into the bloodstream, this medicine is not expected to be harmful during pregnancy or while nursing a baby. Tell your doctor if you are pregnant or breast-feeding.

How is Kayexalate given?

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

Kayexalate can be given as a liquid by mouth, through a stomach feeding tube, or as a rectal enema.

Do not give Kayexalate orally (by mouth) to a newborn baby. Do not use the medicine orally or rectally in a baby who has slow digestion caused by surgery or by using other medicines.

To give this medicine orally: Mix the Kayexalate powder with water, or with honey or jam to make it taste better. Avoid inhaling the oral powder while you are preparing a dose.

Do not mix the powder with any juice or other liquid that contains potassium, such as orange juice.

The rectal enema form of this medicine is usually given by a healthcare professional. The enema will be inserted slowly while you are lying down. You may need to hold in the enema for up to several hours. The Kayexalate enema is usually followed with a second cleansing enema.

You will need frequent medical tests to help your doctor determine how long to treat you with Kayexalate.

Keep using this medicine even if you feel fine. Hyperkalemia often has no symptoms that you will notice until your potassium levels are very low.

Store at room temperature away from moisture and heat.

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?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Kayexalate?

Avoid using antacids or laxatives without your doctor’s advice. Antacids or laxatives can make Kayexalate less effective, or cause serious side effects.

Do not use potassium supplements, calcium supplements, or salt substitutes while you are taking Kayexalate, unless your doctor has told you to.

Avoid eating or drinking anything that contains sorbitol (a fruit sugar often used as a sweetener in chewing gum, diet drinks, baked goods, or frozen desserts).

What is Keflex?

Keflex is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Keflex is used to treat infections caused by bacteria, including upper respiratory infections, ear infections, skin infections, urinary tract infections and bone infections.

Keflex is used to treat infections in adults and children who are at least 1 year old.

Warnings

You should not use Keflex if you are allergic to cephalexin or to similar antibiotics, such as Ceftin, Cefzil, Omnicef, and others. Tell your doctor if you are allergic to any drugs, especially penicillins or other antibiotics.

Tell your doctor if you have kidney disease, liver disease, a stomach or intestinal disorder such as colitis, or diabetes.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Keflex will not treat a viral infection such as the common cold or flu.

Before taking this medicine

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

• an allergy to any drug (especially penicillin);
• liver or kidney disease; or
• intestinal problems, such as colitis.

Tell your doctor if you are pregnant or breast-feeding.

How should I take Keflex?

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

Do not use Keflex to treat any condition that has not been checked by your doctor.

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. Cephalexin will not treat a viral infection such as the flu or a common cold.

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

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

Store the tablets and capsules 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 .

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, and blood in your urine.

What to avoid

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Keflex side effects

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• unusual tiredness, feeling light-headed or short of breath;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• a seizure;
• pale skin, cold hands and feet;
• yellowed skin, dark colored urine;
• fever, weakness; or
• pain in your side or lower back, painful urination.

Common Keflex side effects may include:

• diarrhea;
• nausea, vomiting;
• indigestion, stomach pain; or
• vaginal itching or discharge.

What is Kenalog topical?

Kenalog contains triamcinolone, a potent corticosteroid. Triamcinolone reduces the actions of chemicals in the body that cause inflammation.

Kenalog topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of triamcinolone (Kenalog Orabase) is used to treat mouth ulcers.

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

Warnings

Use Kenalog exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Kenalog can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

Avoid using Kenalog on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use Kenalog on a child without a doctor’s advice. Children are more sensitive to the effects of Kenalog.

Kenalog topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Before using Kenalog

Do not use Kenalog if you are allergic to triamcinolone.

To make sure you can safely use Kenalog, tell your doctor if you have any of these other conditions:

• any skin infection, especially tuberculosis infection of the skin;
• chicken pox or herpes infection (including cold sores);
• diabetes; or
• a stomach ulcer.

It is not known whether Kenalog will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether triamcinolone passes into breast milk or if it could harm a nursing baby. Do not use Kenalog without telling your doctor if you are breastfeeding a baby. Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of Kenalog.

How should I use Kenalog?

Use Kenalog exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Kenalog topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using Kenalog to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using Kenalog on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

If you are using the dental paste, apply the medication in a thin layer, just enough to cover the mouth ulcer. The paste may stick better if you dry the mouth ulcer before applying the medication.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Kenalog can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use Kenalog regularly to get the most benefit.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line , especially if anyone has accidentally swallowed this medicine. An overdose of Kenalog applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid?

Avoid getting Kenalog in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use Kenalog on sunburned, windburned, irritated, or broken skin. Also avoid using Kenalog in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime. Avoid using other medications on the areas you treat with Kenalog unless your doctor tells you to.

Kenalog side effects

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

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone through your skin or gums:

• blurred vision, or seeing halos around lights;
• uneven heartbeats;
• mood changes;
• sleep problems (insomnia);
• weight gain, puffiness in your face; or
• feeling tired.

Less serious Kenalog side effects may include:

• skin redness, burning, itching, or peeling;
• thinning of your skin; or
• blistering skin; or
• stretch marks.

What is Kcentra?

Kcentra is a blood coagulation factor replacement product.

Kcentra is used to quickly reverse the effects of a blood-thinning medicine (such as warfarin) during a major bleeding episode, or when there is a need for emergency surgery or invasive medical procedure.

Kcentra is for use in adults and dosing is based on body weight.

Warnings

While using Kcentra, tell your caregivers right away if you have signs of a blood clot: sudden numbness or weakness, problems with vision or speech, chest pain, cough, wheezing, rapid breathing, swelling or pain in your arms, legs, or stomach.

Tell your doctor if you have ever had a heart attack, stroke, TIA or “mini-stroke”, chest pain, severe circulation problems, or a blood clot (especially within the past 3 months).

Kcentra is for use in people who use blood thinners such as warfarin. After you are treated with this medicine, do not start using your blood thinner again until your doctor tells you to.

Before taking this medicine

You should not be treated with Kcentra if you have:

• low levels of platelets in your blood after using heparin;
• excessive blood-clotting caused by a condition called disseminated intravascular coagulation; or
• a history of severe allergic reaction to prothrombin complex, Protein C or Protein S, Antithrombin III, heparin, human albumin, or Factors II, VII, IX, X.

If possible before you receive Kcentra, tell your caregivers if you have ever had:

• a stroke, including TIA (transient ischemic attack) or “mini-stroke”;
• a heart attack;
• disseminated intravascular coagulation;
• severe circulation problems;
• chest pain (angina); or
• if you have had a blood-clot within the last 3 months.

Tell your doctor if you are pregnant or breastfeeding.

Kcentra 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.

How is Kcentra given?

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

After you are treated with Kcentra, do not start using your blood thinner again until your doctor tells you to.

In case of emergency, wear or carry medical identification to let others know you use a blood thinner.

Dosing information

Usual Adult Dose for Reversal of Acquired Coagulation Factor Deficiency:

INR 2 to less than 4: 25 units of Factor IX/kg body weight given intravenously
INR 4 to 6: 35 units of Factor IX/kg body weight given intravenously
INR greater than 6: 50 units of Factor IX/kg body weight given intravenously

Maximum dose:
INR 2 to less than 4: 2500 units of Factor IX
INR 4 to 6: 3500 units of Factor IX
INR greater than 6: 5000 units of Factor IX

Duration of therapy: Single dose. Repeat dosing is not supported by clinical data and is not recommended.

Comments:
-Administer Vitamin K concurrently to maintain Vitamin K dependent clotting factor levels once the effects of Kcentra concentrate have diminished.
-Individualize dosing based on the patient’s current predose International Normalized Ratio (INR) value, and body weight.
-Dose is based on body weight up to but not exceeding 100 kg. Do not exceed stated maximum dose for patients weighing more than 100 kg.
-Dosing is based on actual potency. The potency varies from vial to vial and is stated on the carton. Potency varies from 20-31 Factor IX units/mL. Nominal potency is 500 units per vial or approximately 25 units per mL after reconstitution.

What happens if I miss a dose?

Since Kcentra is used when needed, it is usually given as a single dose.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving Kcentra?

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

Kcentra side effects

Get emergency medical help if you have signs of an allergic reaction to Kcentra: hives, rash; nausea, vomiting, feeling light-headed; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;
• chest pain or pressure, pain when you breathe, shortness of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot deep in the body – swelling or pain in your arms, legs, or stomach.

Common Kcentra side effects may include:

• low blood pressure;
• anemia;
• nausea, vomiting; or
• headache.

What is Kenalog-40?

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions, including severe allergic reactions, skin disorders (including those caused by autoimmune disorders), severe colitis, inflammation of the joints or tendons, blood cell disorders, inflammatory eye disorders, lung disorders, and problems caused by low adrenal gland hormones. Kenalog-40 contains triamcinolone acetonide 40mg/mL.

Kenalog-40 was FDA-approved on February 1, 1965.

Warnings

• Rarely, anaphylactic reactions have occurred in patients receiving corticosteroids, including triamcinolone acetonide injections.
• Because Kenalog-40 is a suspension, it must not be administered intravenously.
• You may not be able to receive Kenalog-40 if you have a fungal infection, or a condition called idiopathic thrombocytopenic purpura (ITP).
• Kenalog-40 injection contains benzyl alcohol and exposure to excessive amounts has been associated with toxicity (such as hypotension and metabolic acidosis), particularly in neonates, and an increased risk of kernicterus (a type of brain damage caused by high levels of bilirubin in a baby’s blood). The amount of benzyl alcohol that causes toxicity is unknown but the combined daily amount of benzyl alcohol from all sources must be considered.
• If given intramuscularly, Kenalog-40 should be injected deeply into a large muscle, such as a gluteal muscle, rather than a deltoid muscle, because of the increased risk of local atrophy (shrinkage of tissue).
• Kenalog-40 is long-acting and not useful in acute stress situations. Supportive corticosteroid treatments may be necessary in times of stress, such as trauma, surgery, or severe illness during treatment with Kenalog-40 and for a year afterward.
• High dosages should not be used for the treatment of traumatic brain injury.

Before taking this medicine

You should not be treated with Kenalog-40 if you are allergic to it.

You may not be able to receive Kenalog-40 if you have an infection or a condition called idiopathic thrombocytopenic purpura (ITP).

Corticosteroids such as Kenalog-40 can affect your body’s response to vaccines. Administration of live or live attenuated vaccines is contraindicated.

Tell your doctor if you have ever had:

• an active or chronic infection, including tuberculosis
• idiopathic thrombocytopenic purpura (ITP)
• high blood pressure, heart problems, a recent heart attack
• cataracts, glaucoma, or herpes infection of the eyes
• a colostomy or ileostomy, or stomach surgery
• a head injury
• a nerve-muscle disorder, such as myasthenia gravis
• a parasite infection that causes diarrhea (such as threadworms)
• a previously unstable or infected joint or one you suspect is currently infected
• a problem with your thyroid or adrenal gland
• a peptic ulcer, diverticulitis, ulcerative colitis
• kidney of liver disease
• low bone mineral density.

Children are more susceptible to the effects of corticosteroids and the use of Kenalog-40 can lead to bone growth inhibition in pediatric patients and growth suppression

Tell your doctor if you are pregnant or breastfeeding.

Corticosteroids such as Kenalog-40 are teratogenic in many species when given in doses equivalent to the human dose and animal studies have shown a higher incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Administer only if the potential benefit justifies the risk.

Systemically administered corticosteroids such as Kenalog-40 appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Be cautious when administering to a breastfeeding woman.

How is Kenalog-40 given?

Kenalog-40 is given through a needle and can be injected into different areas of the body: into a muscle, into the space around a joint or tendon, or a lesion on the skin. A healthcare provider will give you this injection.

Systemic (intramuscular)

The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending on the condition being treated and the person being treated.

• The suggested initial intramuscular dose is 60mg, injected deep into the gluteal muscle then dosage is usually adjusted within the range of 40mg to 80mg. Some patients may be controlled on dosages as low as 20mg or less.
• The dose should be individualized and the lowest dose used to control the condition.
• Single seasonal injections of 40mg to 100mg may be effective for patients with hay fever or pollen asthma not responding to conventional therapy.
• For children, an initial dosage range of 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m²bsa/day) is suggested.

Intra-articular

Single local injections are usually sufficient but several injections may be needed.

Initial dose: 2.5mg – 5 mg (up to 10mg) for smaller joints and from 5mg – 15mg (up to 40mg) for larger joints.

Other information

Kenalog-40 can weaken (suppress) your immune system, and you may get an infection more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, weakness, cold or flu symptoms, skin sores, diarrhea, frequent or recurring illness). Viral infections, such as chickenpox or measles may have a more serious or even fatal course in children and adults.

Long-term use of steroids can cause harmful effects on the eyes. If you receive Kenalog-40 for longer than 6 weeks, your doctor may want you to have regular eye exams.

Your doctor may instruct you to limit your salt intake while you are receiving Kenalog-40. You may also need to take potassium supplements. Follow all instructions.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Kenalog-40.

You should not stop using Kenalog-40 suddenly after long-term repeated use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for a scheduled Kenalog-40.

When Kenalog-40 is used as a single dose, you will not be on a regular dosing schedule.

What happens if I overdose?

Since Kenalog-40 is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Using too much Kenalog-40 is not likely to cause serious problems. However, long-term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while receiving Kenalog-40?

After injection of triamcinolone into a joint, avoid overusing that joint through strenuous activity or high-impact sports. You could cause damage to the joint.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Kenalog-40.

Do not receive a “live” vaccine or a toxoid vaccine while using Kenalog-40, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Toxoid vaccines include diphtheria-tetanus toxoid (DT or Td).

What are the side effects of Kenalog-40?

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

Kenalog-40 may cause serious side effects. Call your doctor at once if you have:

• (after injection into a joint space) increased pain or swelling, joint stiffness, fever, and general ill feeling
• blurred vision, tunnel vision, eye pain, or seeing halos around lights
• unusual changes in mood or behavior
• swelling, rapid weight gain, feeling short of breath
• stomach cramps, vomiting, diarrhea, bloody or tarry stools, rectal irritation
• sudden numbness or weakness (especially on one side of the body)
• a seizure (convulsions)
• severe headache, blurred vision, pounding in your neck or ears
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes
• signs of low adrenal gland hormones–flu-like symptoms, headache, depression, weakness, tiredness, diarrhea, vomiting, stomach pain, craving salty foods, and feeling light-headed.

Certain side effects may be more likely with long-term use or repeated doses of Kenalog-40, such as osteoporosis.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Kenalog-40.

Common side effects of Kenalog-40 may include:

• skin changes (acne, dryness, redness, bruising, discoloration)
• increased hair growth, or thinning hair
• nausea, bloating, appetite changes
• stomach or side pain
• cough, runny or stuffy nose
• fluid retention
• headache, sleep problems (insomnia)
• a wound that is slow to heal
• sweating more than usual
• changes in your menstrual periods.

What is Keppra?

Keppra is an anti-epileptic drug, also called an anticonvulsant.

Keppra is a  prescription medicine used to treat certain types of seizures in people with epilepsy, including partial onset seizures, myoclonic seizures, and tonic-clonic seizures.

When used for partial onset seizures:

• Keppra XR is for adults and children at least 12 years old.
• Keppra (immediate release tablets or oral solution) may be used in children as young as 1 month old.

Keppra is also used with other seizure medications to treat tonic-clonic seizures in people who are at least 6 years old, and myoclonic seizures in people at least 12 years old.

Keppra injection is used only as an alternative for patients when oral use is temporarily not possible.

Warnings

Do not stop using Keppra without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using this medicine suddenly. You may need to use less and less before you stop the medication completely.

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

Wear a medical alert tag or carry an ID card stating that you take Keppra. Any medical care provider who treats you should know that you take seizure medication.

Keppra may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking levetiracetam during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both the mother and the baby. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by using this medicine.

Before taking this medicine

You should not use Keppra if you are allergic to levetiracetam.

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

• kidney disease (or if you are on dialysis);
• depression or other mood problems;
• mental illness or psychosis; or
• suicidal thoughts or actions.

Do not give this medicine to a child without medical advice. Different brands of levetiracetam are for use only in children of certain ages.

Some people have thoughts about suicide while taking Keppra. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor if you become pregnant. Your dose needs may be different during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levetiracetam on the baby.

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

How should I take Keppra?

Take Keppra 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.

Keppra oral is taken by mouth at the same time each day, with or without food.

Keppra injection is given in a vein if you are unable to take the medicine by mouth.

Your dose needs may change if you switch to a different brand, strength, or form of levetiracetam. A child’s dose needs may change if the child gains or loses weight. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

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

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

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

Your kidney function may need to be tested.

Use all seizure medications as directed. Do not change your dose or stop using a medicine without your doctor’s advice.

Seizures may increase if you stop using Keppra suddenly.. Ask your doctor before stopping the medicine.

Wear a medical alert tag or carry an ID card to let others know you have seizures.

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.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include extreme drowsiness, agitation, aggression, shallow breathing, weakness, or fainting.

What should I avoid while taking Keppra?

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

Keppra side effects

Get emergency medical help if you have signs of an allergic reaction to Keppra (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).

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

Call your doctor at once if you have:

• unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);
• confusion, hallucinations, extreme drowsiness, feeling very weak or tired;
• loss of balance or coordination, problems with walking or movement;
• a skin rash, no matter how mild;
• easy bruising, unusual bleeding; or
• fever, chills, weakness, or other signs of infection.

Common Keppra side effects may include:

• dizziness, drowsiness, tiredness, weakness;
• feeling aggressive or irritable;
• loss of appetite;
• stuffy nose; or
• infection.

Uses for Keppra XR

Levetiracetam is used alone or together with other medicines to help control certain types of seizures (eg, partial seizures, myoclonic seizures, or tonic-clonic seizures) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

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

Before using Keppra XR

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 have not been performed on the relationship of age to the effects of levetiracetam oral solution, tablets, or tablets for suspension in children younger than 1 month of age (Keppra®) or in children younger than 4 years of age and weighing less than 20 kilograms (Spritam®, Spritam® tablets for oral suspension), and levetiracetam extended-release tablets in children younger than 12 years of age (Elepsia XR) or (Keppra XR®). Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levetiracetam in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving levetiracetam.

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 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.

• Apixaban
• Calcifediol
• Dabigatran Etexilate Mesylate
• Edoxaban
• Levoketoconazole
• Methotrexate
• Orlistat
• Rivaroxaban

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.

• Carbamazepine
• Ginkgo

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Depression, history of or
• Hypertension (high blood pressure) or
• Mental illness, history of—Use with caution. May make these conditions worse.
• Kidney disease, moderate to severe—Use is not recommended in patients with this condition.
• Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of Keppra XR

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change your dose without checking first with your doctor.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Levetiracetam may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed. You should try to take this medicine at the same time each day.

Swallow the tablet or the extended-release tablet whole. Do not break, crush, or chew it. There is an oral liquid form of this medicine if you or your child cannot swallow the tablets.

Elepsia XR extended-release tablet has a blue and white to off-white layer. If you do not see the blue or white, off-white layer, do not take the tablet.

A part of the tablet may also pass into your stool. This is normal and is nothing to worry about.

If you are using the Spritam® tablet or the Spritam® tablet for suspension, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue and take a sip of water. After it has melted, swallow.

You may also add one whole Spritam® tablet for suspension to a small volume of liquid in a cup (1 tablespoon or enough to cover the medicine), and swirl gently. Swallow right away after it has dissolved. Then add a small volume of liquid to cup again, swirl gently, and swallow the liquid.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you have any questions about this, ask your doctor or pharmacist.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you otherwise.

Take only the form of this medicine that your doctor prescribed. If you refill your prescription and your pills look different, do not take the medicine and tell your doctor or pharmacist right away.

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.

• For oral dosage form (extended-release tablets):
  • For treatment of partial-onset seizures:
    • Adults and children 12 years of age and older and weighing 50 kilograms (kg) or more—At first, 1000 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (Keppra® solution or tablets):
  • For partial onset seizures:
    • Adults and children 16 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children 6 months to 3 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per kg of body weight per day.
    • Children 1 to 5 months of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 42 mg per kg of body weight per day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.
  • For juvenile myoclonic seizures:
    • Children 12 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 16 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (Spritam® tablets, Spritam® tablets for suspension):
  • For partial onset seizures:
    • Adults and children 4 years of age and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 years of age and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 4 years of age and weighing less than 20 kg—Use is not recommended.
  • For juvenile myoclonic seizures:
    • Children 12 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 6 years of age and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 years of age and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 6 years of age and weighing less than 20 kg—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 Keppra XR

It is very important that your doctor check your or your child’s progress at regular visits, especially for the first few months you or your child are using this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Do not stop using levetiracetam without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Side Effects of Keppra XR

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:

More common

• Aggressive or angry
• anxiety
• change in personality
• chills
• cough
• crying
• deep or fast breathing with dizziness
• delusions of persecution, mistrust, suspiciousness, or combativeness
• diarrhea
• dry mouth
• false or unusual sense of well-being
• feeling of unreality
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• irregular heartbeat
• irritability
• joint pain
• loss of appetite
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• numbness of the feet, hands, and around the mouth
• painful or difficult urination
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• sense of detachment from self or body
• shaking
• shivering
• sleepiness or unusual drowsiness
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bloody nose
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• clumsiness or unsteadiness
• discouragement
• dizziness or lightheadedness
• double vision
• earache
• feeling of constant movement of self or surroundings
• feeling sad or empty
• increase in body movements
• loss of bladder control
• loss of memory
• mood or mental changes
• outburst of anger
• pain or tenderness around the eyes and cheekbones
• problems with memory
• redness or swelling in the ear
• seizures
• sensation of spinning
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• tightness of the chest
• trembling or shaking of the hands or feet
• trouble concentrating
• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Agitation
• attempts at killing oneself
• being forgetful
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• changes in vision
• chest pain
• coma
• confusion
• constipation
• dark urine
• decreased urine output
• difficulty with moving
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• indigestion
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• muscle pains, stiffness, or twitching
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• skin rash, encrusted, scaly, and oozing
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• stupor
• swelling of the face, ankles, or hands
• swollen glands
• swollen joints
• thoughts or attempts at killing oneself
• trouble with balance
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled jerking or twisting movements of the hands, arms, or legs
• uncontrolled movements of the lips, tongue, or cheeks
• unexplained bleeding or bruising
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• weight loss
• yellow eyes or skin

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:

More common

• Loss of strength or energy
• muscle pain or weakness
• pain
• tender, swollen glands in the neck
• trouble swallowing
• unusual weak feeling
• voice changes

Less common

• Body aches or pain
• burning, dry, or itching eyes
• change in the color of the skin
• congestion
• cough increased
• sneezing

Incidence not known

• Hair loss or thinning of the hair

What is Kerendia?

Kerendia (finerenone) is a  FDA approved tablet taken once a day by adults who have chronic kidney disease from type 2 diabetes.  Kerendia is used to slow down kidney damage, and also to reduce the risk of kidney failure, cardiovascular death, heart attack and being hospitalized for heart failure. Kerendia is from the class of meds called mineralocorticoid receptor antagonists.

Chronic kidney disease (CKD) is when your kidneys are not working properly and they work less effectively over time. Having type 2 diabetes increases your chances of having chronic kidney disease. Often type 2 diabetics do not have any symptoms in the early stages of CKD and they might not realize they have it until it is advanced and they may need to have dialysis or kidney transplant to survive. If you have diabetes it is important to get your kidneys checked regularly by having a blood and urine test, if you have signs of reduced kidney function or the start of CKD early treatment can help prevent you having extra health problems. 

Buy vitamins and supplements

When you have CKD you have health problems from fluid, electrolytes (minerals required for many bodily processes), and waste building up in the body. If you have CKD you are also at high risk of heart disease.

How does Kerendia work and what is its mechanism of action?

One of the reasons CKD can get worse in diabetes is due to inflammation and scarring of the kidneys.  

How Kerendia is thought to work is:

• There is a receptor in the kidneys, heart and blood vessels tissues that is called mineralocorticoid receptor (MR). 
• When MR is overactive it leads to inflammation, tissue damage and scarring, which is thought to cause kidney disease and cardiovascular disease to become worse.
• Kerendia blocks the MR so that it is not as active, so the MR is less likely to cause as much inflammation and damage to kidneys, blood vessels and heart.
• This means Kerendia slows CKD from getting worse and also lowers the risk of cardiovascular death, having a heart attack or needing to be hospitalized for heart failure.

Before taking this medicine

You should not use Kerendia if you are allergic to it, or if you have problems with your adrenal gland.

Some drugs should not be used with this medicine. Your treatment plan may change if you also use:

• nefazodone;
• the antibiotics clarithromycin or telithromycin;
• antifungal medicine–itraconazole, ketoconazole, posaconazole, voriconazole; or
• antiviral medicine for HIV or hepatitis C–boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir,
• lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

Tell your doctor if you have ever had:

• severe liver disease; or
• high blood levels of potassium (hyperkalemia).

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

You should not breastfeed while using finerenone, and for at least 1 day after your last dose.

Not approved for use by anyone younger than 18 years old.

How should I take Kerendia?

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 finerenone with or without food.

If you cannot swallow a tablet whole, crush the tablet and mix it with water or soft food such as applesauce. Swallow the mixture right away.

You will need  medical tests.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Kerendia?

Do not take potassium  supplements or use salt substitutes, unless your doctor has told you to.

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

Kerendia side effects

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

Treatment with Kerendia may cause serious side effects. Call your doctor at once if you have:

• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• low blood sodium–headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Common Kerendia side effects may include:

• high potassium;
• low sodium; or
• low blood pressure.

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 .

Kerendia dosing information

Usual Adult Dose for Chronic Kidney Disease:

Initial dose:

For estimated glomerular filtration rate (eGFR) at least 60 mL/min/1.73 m2: 20 mg orally once a day

For eGFR 25 to less than 60 mL/min/1.73 m2: 10 mg orally once a day

Target dose:

20 mg orally once a day

Comments:

Initiation of therapy is not recommended if serum potassium is greater than 5 mEq/L.

If serum potassium levels are greater than 4.8 to 5 mEq/L, initiation of therapy may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels.

What is Kesimpta?

Kesimpta (ofatumumab) is an FDA-approved medicine used to slow the progression and risk of relapses for specific forms of relapsing multiple sclerosis (MS). It is a once-a-month injection given under the skin (subcutaneously) that you can self-administer in your own home.

Kesimpta’s mechanism of action is thought to involve binding to and decreasing numbers of B cells. These are a type of white blood cell called B-lymphocytes that produce antibodies and are more abundant in people with MS, particularly those with active disease. Kesimpta binds to CD20, a protein on the surface of pre-B and mature B cells, triggering the destruction of the cell. Kesimpta will not cure MS but clinical trials show it slows its progression and reduces the rate of relapse.

Kesimpta belongs to the drug class called CD20 monoclonal antibodies. Kesimpta may also be called a selective immunosuppressant.

Kesimpta gained FDA approval on October 26, 2009. There is no Kesimpta generic (more correctly called a biosimilar). 

What is Kesimpta used for?

Kesimpta is used in adults with specific types of relapsing forms of multiple sclerosis (MS) including:

• clinically isolated syndrome (CIS)
• relapsing-remitting MS (RRMS)
• active secondary progressive disease (active SPMS).

Clinical trials have shown Kesimpta starts to work to lower B cells within a week. Symptoms of MS may take a bit longer to resolve.

Important Note:  Arzerra Vs Kesimpta

Although Arzerra contains the same active ingredient as Kesimpta (ofatumumab), they are NOT interchangeable.

• They are used to treat different conditions (Arzerra is used for CLL and Kesimpta is used for MS).
• They are given by different routes of administration (Arzerra is given by intravenous infusion and Kesimpta is given by subcutaneous injection).

Kesimpta side effects

The most common side effects of Kesimpta are:

• upper respiratory tract infections (these are typically viral infections that cause sneezing, nasal congestion, a headache, and a sore throat)
• headache.

Serious side effects and warnings

Kesimpta can cause the following serious side effects.

Infections. Clinical trials have reported serious infections associated with Kesimpta. If you have an active infection, your healthcare provider should delay your treatment until your infection is gone. Kesimpta taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches.

Hepatitis B virus (HBV) reactivation. Before starting treatment, your healthcare provider will do blood tests to check for HBV. If you have ever had an HBV infection, the HBV may become active again during or after treatment. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. You should not receive this medicine if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using this medicine. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment.

Progressive Multifocal Leukoencephalopathy (PML). PML may happen with this medicine. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory which may lead to confusion and personality changes.

Weakened immune system. Kesimpta taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Injection-related reactions. Injection-related reactions are a common side effect of Kesimpta. These can happen within 24 hours (1 day) following the first injection and with later injections. There are 2 kinds of reactions:

• at or near the injection site: redness of the skin, swelling, itching and pain. Talk with your healthcare
  provider if you have any of these signs and symptoms.
• those that may happen when certain substances are released in your body: fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness. Contact your healthcare provider right away if you experience any of these signs and symptoms, especially if they become worse or you have new severe signs of reactions after subsequent injections. It could be a sign of an allergic reaction, which can be serious.

Low immunoglobulins. Kesimpta may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

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

Before using Kesimpta

Do not use Kesimpta if you:

• have an active hepatitis B virus infection
• have had an allergic reaction to ofatumumab or a life-threatening injection-related reaction to Kesimpta.

Before using this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection including HBV or PML
• have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with this medicine and until your healthcare provider tells you that your immune system is no longer weakened.
  • Whenever possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Kesimpta.
  • Talk to your healthcare provider about vaccinations for your baby if you used Kesimpta during your pregnancy.
• are pregnant, think you might be pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if this medicine will harm your unborn baby. Females who can become pregnant should use birth control (contraception) during treatment with this medicine and for 6 months after your last treatment. Talk with your healthcare provider about what birth control method is right for you during this time.

Breastfeeding

 It is not known if this medicine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medicine.

How should I use Kesimpta?

See the detailed Instructions for Use that come with the Kesimpta Package Insert for information about how to prepare and inject a dose of this medicine and how to properly throw away (dispose of) used pens or prefilled syringes.

• Use Kesimpta exactly as your healthcare provider tells you to use it.
• Kesimpta is given as an injection under your skin (subcutaneous injection), in your thigh or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection in your upper outer arm. See Where and how is Kesimpta injected? for more information.
• Your healthcare provider will show you how to prepare and inject this medicine the right way before you use it for the first time.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with moles, scars, or stretch marks.

Kesimpta dosing

• Initial dosing: Kesimpta 20 mg of Kesimpta given by subcutaneous injection at Weeks 0, 1, and 2.
• Subsequent dosing: Kesimpta 20 mg administered monthly starting at week 4.
• There is no injection at Week 3.

What happens if I miss a dose?

If you miss a monthly injection, give it as soon as possible without waiting until the next scheduled dose. After that, use your injections a month apart.

What other drugs will affect Kesimpta?

Tell your doctor about all your other medicines, especially drugs that weaken the immune system such as

• cancer medicine
• steroids
• medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect Kesimpta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. 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 of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I store Kesimpta?

Store Kesimpta in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep it in the original carton until ready for use to protect it from light.

If needed, Kesimpta may be stored for up to 7 days at room temperature, up to 86°F (30°C ). Write the date taken out of the refrigerator in the space provided on the carton.

If stored below 86°F (30°C), unused Kesimpta may be returned to the refrigerator and must be used within the next 7 days. If this Kesimpta is not used within those 7 days, then discard the medicine.

Do not freeze. Do not shake.

Keep Kesimpta and all medicines out of the reach of children.

What are the ingredients in Kesimpta?

Active ingredient: ofatumumab
Inactive ingredients: Sensoready pen and prefilled syringe: arginine, disodium edetate, polysorbate 80, sodium acetate trihydrate, sodium chloride, and Water for Injection. Hydrochloric acid may be added.

Available as Kesimpta 20 mg/0.4 mL solution in a single-dose prefilled Sensoready Pen and Kesimpta 20 mg/0.4 mL solution in a single-dose prefilled syringe.

Who makes Kesimpta?

Kesimpta is made by Novartis, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis was founded in 1996 through the merger of Ciba-Geigy and Sandoz. Some of Novartis’s other notable medications include:

• Entresto (for heart failure)
• Cosentyx (for psoriasis and arthritis)
• Gilenya (for multiple sclerosis)
• Zolgensma (for spinal muscular atrophy)
• Leqvio (for cholesterol management)
• Xolair (for asthma and allergic conditions)
• Tasigna (for leukemia)
• Tafinlar (for melanoma)
• Promacta (for blood disorders)
• Kisqali (for breast cancer).

What is Ketalar?

Ketalar is used to put you to sleep for surgery and to prevent pain and discomfort during certain  medical tests or procedures.

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

Ketalar 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.

Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia.

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

• painful or difficult urination, increased urination, loss of bladder control, blood in your urine;
• a light-headed feeling, like you might pass out;
• slow heart rate, weak or shallow breathing; or
• jerky muscle movements that may look like convulsions.

Common side effects of Ketalar may include:

• confusion; or
• dream-like feeling.

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

Warnings

Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia.

Before taking this medicine

You should not be treated with Ketalar if you are allergic to it, or if you have untreated or uncontrolled hypertension (high blood pressure).

Tell your doctor if you have ever had:

• heart disease;
• high blood pressure;
• liver disease;
• alcoholism; or
• if you drink large amounts of alcohol.

Tell your doctor if you are pregnant or breastfeeding.

Anesthesia may affect brain development in a young child or unborn baby (when used in the mother), leading to learning or behavior problems later in life. Long surgeries or repeated procedures pose the highest risks.

Anesthesia may still be necessary for a life-threatening condition, medical emergency, or surgery to correct a birth defect. Your doctor can give inform you about all medicines given during a surgery or procedure.

Ask a doctor if it is safe to breastfeed shortly after you receive Ketalar.

How is Ketalar given?

Ketalar is injected into a muscle or a vein. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

You may feel strange or confused when you awake from anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

What happens if I miss a dose?

Ketalar is used as a single dose and does not have a daily dosing schedule.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving Ketalar?

Ketalar may impair your thinking or reactions for several hours. Avoid driving or operating machinery for at least 24 hours after you receive Ketalar.

What other drugs will affect Ketalar?

It may take you longer to recover from anesthesia if you use other drugs that make you sleepy or slow your breathing. This includes opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

What is ketamine?

Ketamine is used as an anesthetic for surgery, a treatment for depression, and is a drug of abuse. Ketamine is FDA-approved as an anesthetic to put you to sleep for surgery and to help prevent pain and discomfort. Ketamine for depression is an off-label use, and its use for depression is currently being researched in clinical trials. It is also a drug of abuse that is used illegally recreationally for its hallucinogenic properties and is known to be a “date rape” drug as it causes short-term memory loss.

Ketamine is not an opioid (narcotic); it is an NMDA receptor antagonist, which means it blocks the N-methyl-D-aspartate (NMDA) neurotransmitter in the brain.

When used for anesthesia, ketamine is given as an intravenous injection (IV) or as an intramuscular injection (IM).

Esketamine (Spravato) is used to treat depression; it is one of the forms of racemic ketamine and was FDA-approved in 2019 for specific types of depression. Spravato is a nasal spray that is used under strict medical supervision and is not used by patients at home.

Ketamine is FDA-approved as a general anesthetic to be used as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is also used to induce anesthesia prior to the administration of other general anesthetic agents and as a supplement to other anesthetic agents. Ketamine is not FDA-approved for depression; it is used off-label for this condition.

Ketamine Therapy

Ketamine infusion therapy has been used for depression in patients with treatment-resistant depression (TRD) for its rapid antidepressant effects. Depression is an off-label use of ketamine as it is not an FDA-approved indication. In clinical trials ketamine therapy is mainly given as intravenous infusion, but may be given as intranasal spray, slow release tablets, sublingual tablets, or other forms.

In clinical trials, ketamine infusions have been given as a single dose once or in multi-dose therapy, as infusions once, twice, or 3 times weekly for 2 weeks during the acute treatment phase. Sometimes infusions have been continued once or twice weekly during the continuation phase for a total of 4–6 weeks of therapy or gradually tapered. In clinical trials ketamine infusion therapy dose is lower than an anesthetic dose. If patients have not responded to several initial infusions, then it appears unlikely that they will respond to further infusions.

Is ketamine a Controlled Substance?

Yes, ketamine is a controlled substance classified as a Schedule III drug under the DEA Controlled Substances Act. This means that ketamine has a potential for abuse that is less than the drugs in schedules I and II. Abuse of the ketamine may lead to a moderate to low potential for physical dependence but high psychological dependence. Drugs that are classified as Schedule III are currently accepted for medical use in treatment in the U.S.

Why is ketamine abused?

Ketamine is abused illegally due to its hallucinogenic and dissociative effects. It leads to changes in sensory experiences, dream-like states, and also a distortion of sights, colors, sounds, self, and one’s environment. Common ketamine street names are Special K, K, super k, ket, ketters, vitamin K, cat tranquilizer, C or horse trank. Ketamine for abuse is usually a clear liquid or an off-white powder. It is often “snorted” up the nose, injected, mixed into drinks, or smoked with marijuana or tobacco. Other dissociative drugs include phencyclidine (PCP), Salvia divinorum, and dextromethorphan (DXM). Hallucinogens include LSD, psilocybin, and mescaline.

Abuse of large doses of this medicine can also lead to powerful visual hallucinations that are intensified by environmental stimuli. Coma and deep unconsciousness can occur. When higher doses of ketamine are abused or during emergence, it is reported to produce vivid dreams and an “out-of-body”, “K-hole” or “near-death” hallucinogenic experience, often reported as terrifying (similar to a bad LSD trip).

Abuse of ketamine can be linked with short-term and long-term problems:

• Short-term problems: Problems with attention, learning, and memory; dreamlike states, hallucinations; sedation; confusion; loss of memory; raised blood pressure; unconsciousness; dangerously slowed breathing.
• Long-term problems: Ulcers and pain in the bladder; kidney problems; stomach pain; depression; poor memory.

There is also the risk of HIV, hepatitis, and other infectious diseases from shared needles.

Ketamine use can be fatal in people who are alcoholics or acutely intoxicated with alcohol. There are animal reports of an increased risk of toxicity when ketamine is combined with caffeine. Theoretically, this may be a concern in people who have consumed energy drinks, often done at nightclubs where this medicine may be abused.

The intensity of side effects is related to the dose of the drug consumed.

Ketamine side effects

Serious ketamine side effects

Serious ketamine side effects include:

• slow heart rate, weak or shallow breathing; or
• a light-headed feeling, like you might pass out;
• jerky muscle movements that may look like convulsions;
• painful or difficult urination, increased urination, loss of bladder control, blood in your urine.

Call your doctor at once if you have any of the above symptoms.

Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia.

Allergic reactions – get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Common ketamine side effects

Common ketamine side effects are confusion or a dream-like feeling.

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

Who should not use ketamine?

Ketamine should not be used in patients for whom a significant elevation of blood pressure would constitute a serious hazard or in patients with known hypersensitivity to ketamine or to any excipient.

Warnings

Emergence reactions Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia.

Hemodynamic instability Temporary increases in blood pressure, heart rate, and cardiac index may be observed during administration. Vital signs and cardiac function should be monitored during administration.

Risk of respiratory depression may occur with overdosage or too rapid a rate of administration. Maintain adequate oxygenation and ventilation

Risks of using ketamine alone for procedures of the pharynx, larynx, or bronchial tree Pharyngeal and laryngeal reflexes are not suppressed with ketamine when it is used alone. Avoid use as a sole anesthetic agent in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Muscle relaxants may be required.

Pediatric neurotoxicity Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, timing, and duration of surgery or procedures requiring anesthetic and sedation drugs.

Drug-induced liver injury is associated with the administration of this medicine.

Increase in cerebrospinal fluid pressure An increase in intracranial pressure has been reported following the administration of this medicine. Patients with elevated intracranial pressure should be in a monitored setting with frequent neurologic assessments.

FDA warning. The FDA released a warning on October 10, 2023, about about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders, as they have not been evaluated for safety, effectiveness, or quality prior to marketing. When these products are used at home, there is an additional risk because onsite monitoring by a healthcare provider is not available

Before taking this medicine

You should not be treated with ketamine if you are allergic to it or if you have untreated or uncontrolled hypertension (high blood pressure).

Tell your doctor if you have ever had:

• heart disease;
• high blood pressure;
• liver disease;
• alcoholism; or
• if you drink large amounts of alcohol.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or breastfeeding.

Anesthesia may affect brain development in a young child or unborn baby (when used in the mother), leading to learning or behavior problems later in life. Long surgeries or repeated procedures pose the highest risks.

Anesthesia may still be necessary for a life-threatening condition, medical emergency, or surgery to correct a birth defect. Your doctor can inform you about all medicines given during a surgery or procedure.

Ask a doctor if it is safe to breastfeed shortly after you receive ketamine.

How should I receive Ketamine?

Ketamine is injected into a muscle or a vein when used medically. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

You may feel strange or confused when you awake from anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

Ketamine dosing information

Usual Adult Ketamine Dose for Anesthesia:

Intravenous injection (IV)
Induction: 1 to 4.5 mg/kg IV; alternatively, 1 to 2 mg/kg IV at a rate of 0.5 mg/kg/min; (2 mg/kg dose provides 5 to 10 minutes of surgical anesthesia within 30 seconds)
Maintenance: The maintenance dose should be adjusted according to the patient’s anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

Intramuscular injection (IM)
Induction: 6.5 to 13 mg/kg IM; (9 to 13 mg/kg IM provides 12 to 25 minutes of surgical anesthesia)
Maintenance: The maintenance dose should be adjusted according to the patient’s anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

Comments: This drug should be administered slowly over a period of 60 seconds (more rapid administration may result in respiratory depression and enhanced pressor response).
The larger the total dose, the longer the complete recovery will be.
Because of rapid induction following the initial IV injection, the patient should be in a supported position during administration.

Usual Pediatric Ketamine Dose for Anesthesia:

16 years and older: See adult dosing.

For more detailed dosing information, click on the link below.

What happens if I miss a dose?

Ketamine is used as a single dose and does not have a daily dosing schedule.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid after receiving ketamine?

Ketamine may impair your thinking or reactions for several hours. Avoid driving or operating machinery for at least 24 hours after you receive ketamine.

What other drugs will affect ketamine?

It may take you longer to recover from anesthesia if you use other drugs that make you sleepy or slow your breathing. This includes opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

What is ketoconazole?

Ketoconazole is an antifungal medication that is used to treat certain infections caused by fungus.

ketoconazole should be used only when you cannot use other antifungal medications. Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.

Ketoconazole is not for use in treating fungal infections of the fingernails or toenails. This medicine is also not for use in treating prostate cancer or Cushing syndrome.

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

Ketoconazole side effects

Get emergency medical help if you have signs of an allergic reaction (hives, fever, chest pain, 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).

Ketoconazole 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);
• unusual weakness or tiredness, dizziness, nausea, and vomiting; or
• liver problems–upper stomach pain, fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Common side effects of ketoconazole may include:

• nausea, diarrhea, stomach pain
• breast swelling;
• headache, dizziness; or
• abnormal liver function tests.

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

ketoconazole should be used only when you cannot use other antifungal medications. Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.

Call your doctor at once if you have any signs of liver damage, such as nausea, vomiting, stomach pain, fever, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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.

Ketoconazole can also cause a serious heart problem. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Before taking this medicine

You should not use ketoconazole if you are allergic to it, or if you have liver disease.

Some medicines can cause unwanted or dangerous effects when used with ketoconazole. Your doctor may change your treatment plan if you also use:

• cisapride;
• colchicine;
• irinotecan;
• methadone;
• tolvaptan;
• antipsychotic medicine–pimozide, lurasidone;
• cholesterol medication–lovastatin, simvastatin, and others;
• ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine;
• heart medication–disopyramide, dofetilide, dronedarone, eplerenone, felodipine, nisoldipine, quinidine, ranolazine; or
• a sedative–alprazolam, midazolam, or triazolam.

Tell your doctor if you have ever had:

• liver problems;
• long QT syndrome (in you or a family member); or
• problems with your adrenal gland.

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

You should not breast-feed while using this medicine.

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

How should I take ketoconazole?

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

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 need to use ketoconazole for up to 6 months.

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. Ketoconazole will not treat a viral infection such as the flu or a common cold.

While using ketoconazole, you may need frequent blood tests to check your liver function.

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

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

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 ketoconazole?

Do not drink alcohol. Dangerous side effects could occur.

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

What other drugs will affect ketoconazole?

Some medicines can make it harder for your body to absorb ketoconazole. If you take an antacid, take it 1 hour before or 2 hours after you take ketoconazole. Tell your doctor if you also take a stomach acid reducer, such as Nexium, Prevacid, Prilosec, Protonix, Zantac, and others.

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.

Ketoconazole can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

What is ketoconazole topical?

Ketoconazole topical (for the skin) is an antifungal medicine used to treat infections such as athlete’s foot, jock itch, ringworm, and seborrhea (dry, flaking skin or dandruff).

Ketoconazole topical is also used to treat a fungal infection called pityriasis, which causes scaly discolored patches on the skin of the neck, chest, arms, or legs.

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

Ketoconazole topical 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.

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

• burning, stinging, or severe irritation after using ketoconazole topical;
• redness, pain, or oozing of treated skin; or
• shortness of breath.

Common side effects of ketoconazole topical may include:

• thinning hair;
• changes in the color or texture of your hair;
• dry skin; or
• mild itching.

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

Warnings

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

Before taking this medicine

You should not use ketoconazole topical if you are allergic to ketoconazole.

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

• asthma or a sulfite allergy;
• an allergic reaction to an antifungal medicine, such as clotrimazole, econazole, or miconazole.

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

You should not breast-feed while using ketoconazole topical.

Always follow directions on the medicine label about using this medicine on a child.

How should I apply ketoconazole topical?

Use exactly as directed on the label, or as prescribed by your doctor.

Using more of this medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or irritated skin. Rinse with water if this medicine gets in your eyes, nose, or mouth.

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

Wash your hands before and after using this medicine.

Clean and dry the skin before applying ketoconazole cream, foam, or gel.

This medicine may be flammable. Do not use near high heat or open flame, or while smoking. Avoid heat or smoking until the medicine has completely dried on your skin.

Ketoconazole shampoo is not for daily use. Allow at least 3 days to pass between uses.

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.

Call your doctor if your symptoms do not begin to improve after 2 to 4 weeks of treatment, or if your condition gets worse.

Store ketoconazole topical at room temperature. Protect from light and do not refrigerate or freeze.

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 ketoconazole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using ketoconazole topical?

Do not get ketoconazole topical in your eyes. If contact does occur, rinse with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn’t allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

You may need to avoid sunlight if you are treating pityriasis. Follow your doctor’s instructions.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with ketoconazole topical unless your doctor tells you to.

What is ketoprofen?

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat signs and symptoms caused by certain types of arthritis and for short-term pain relief.

Ketoprofen immediate-release capsule can also be used to treat menstrual pain.

Ketoprofen extended-release capsule is only used for treating arthritis. This brand form of ketoprofen will not work fast enough to treat acute (immediate) pain.

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

Ketoprofen 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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

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

• diarrhea, gas, heartburn, flu-like symptoms;
• a skin rash, no matter how mild;
• high blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• kidney or heart problems–swelling, urinating less, rapid weight gain, feeling tired or short of breath;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, nausea, vomiting, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Ketoprofen may also worsen asthma attacks in people who have asthma. Talk with your doctor about your own risk.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of ketoprofen may include:

• heartburn, stomach pain, gas, nausea;
• headache, kidney problems;
• diarrhea, constipation; or
• insomnia, nervousness.

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

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

Before taking this medicine

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

Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

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

Tell your doctor if you have or have ever had:

• heart disease, high blood pressure, high cholesterol, smoking, diabetes;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• fluid retention; or
• liver or kidney disease.

Do not use ketoprofen during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

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

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

How should I take ketoprofen?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition. Do not use ketoprofen more often than prescribed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Take this medicine with food or milk if it upsets your stomach.

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

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

You may need medical tests to check your heart and kidney function. Your blood pressure will need to be checked often.

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

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ketoprofen?

Do not take ketoprofen immediate-release capsules and extended-release capsules at the same time.

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

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

What other drugs will affect ketoprofen?

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

Ketoprofen can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• aspirin;
• probenecid;
• a blood thinner–warfarin, Coumadin, Jantoven;
• medicine used to prevent blood clots–alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• steroid medicine (such as prednisone).

What is ketorolac ophthalmic?

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

Ketorolac ophthalmic (for the eye) is used to relieve eye itching caused by seasonal allergies.

Ketorolac ophthalmic is also used to reduce swelling, pain, and burning or stinging after cataract surgery or corneal refractive surgery.

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

Ketorolac ophthalmic 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.

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

• severe burning, stinging, or itching of your eyes;
• a wound that will not heal;
• eye pain, redness, or watering;
• vision changes, increased sensitivity to light;
• white patches on your eyes; or
• crusting or drainage from your eyes.

Common side effects of ketorolac ophthalmic may include:

• mild eye pain, stinging, or redness;
• blurred vision;
• watery eyes;
• swollen or puffy eyelids; or
• headache.

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

Warnings

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 ketorolac ophthalmic if you are allergic to ketorolac. Tell your doctor if you are allergic to any other NSAIDs, such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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

• a bleeding or blood-clotting disorder;
• diabetes;
• arthritis;
• glaucoma;
• dry eye syndrome; or
• a condition for which you take a blood thinner such as warfarin (Coumadin, Jantoven).

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

It is not known whether ketorolac ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

How should I use ketorolac ophthalmic?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ketorolac ophthalmic is used 2 to 4 times per day, depending on the condition you are treating. Follow your doctor’s dosing instructions very carefully. Prolonged use of NSAID eye drops can lead to serious damage to your eyesight.

For cataract surgery you will begin using the eye drops 1 day before surgery and continue for up to 2 weeks afterward. For corneal refractive surgery the usual dosage is 4 times daily for up to 4 days after surgery.

Do not use ketorolac ophthalmic while you are wearing contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
• If using this medicine after single-eye surgery, use the drops only in the eye you are having surgery on.
• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of this medicine is for use in one eye only. Throw away after one use, even if there is still some medicine left in the vial.

Store at room temperature away from moisture, heat, and light. Do not freeze. Keep the bottle tightly closed when not in use. If your medicine vials come in a foil pouch, store the vials inside the pouch and fold the ends closed.

Ketorolac ophthalmic dosing information

Usual Adult Dose for Corneal Refractive Surgery:

0.4% Ophthalmic Solution: Instill 1 drop in the operated eye(s) four times a day as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery

Use: For the relief of ocular pain and burning/stinging following corneal refractive surgery

Usual Adult Dose for Postoperative Ocular Inflammation:

0.45% Ophthalmic Solution: Instill 1 drop in the affected eye(s) twice a day beginning 1 day prior to cataract surgery, continuing on the day of surgery, and through the first 2 weeks of the postoperative period

0.5% Ophthalmic Solution: Instill 1 drop in the affected eye(s) four times a day beginning 24 hours after cataract surgery and continue through the first 2 weeks of the postoperative period

Use: For the treatment of pain and inflammation following cataract surgery

Usual Adult Dose for Seasonal Allergic Conjunctivitis:

0.5% Ophthalmic Solution: Instill 1 drop in the affected eye(s) four times a day

Use: For the temporary relief of ocular itching due to seasonal allergic conjunctivitis

Usual Pediatric Dose for Corneal Refractive Surgery:

3 years or older:
0.4% Ophthalmic Solution: Instill 1 drop in the operated eye(s) four times a day as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery

Use: For the relief of ocular pain and burning/stinging following corneal refractive surgery

Usual Pediatric Dose for Postoperative Ocular Inflammation:

2 years or older:
0.5% Ophthalmic Solution: Instill 1 drop in the affected eye(s) four times a day beginning 24 hours after cataract surgery and continue through the first 2 weeks of the postoperative period

Uses: For the treatment of pain and inflammation following cataract surgery

Usual Pediatric Dose for Seasonal Allergic Conjunctivitis:

2 years or older:
0.5% Ophthalmic Solution: Instill 1 drop in the affected eye(s) four times a day for the relief of ocular itching

Use: For the temporary relief of ocular itching due to seasonal allergic conjunctivitis

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of ketorolac ophthalmic 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 ketorolac ophthalmic?

While using this medication, do not wear any contact lens that has not been approved by your doctor.

Introduction

Relatively selective histamine H₁-receptor antagonist and mast-cell stabilizer.

Uses for Ketotifen

Allergic Conjunctivitis

Self-medication for temporary relief of ocular itching associated with allergic conjunctivitis (i.e., conjunctivitis due to pollen, grass, ragweed, or animal hair or dander).

Ketotifen Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.

Dosage

Available as ketotifen fumarate; dosage expressed in terms of ketotifen.

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours) for those ≥3 years of age.

Adults

Allergic Conjunctivitis

Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours).

Prescribing Limits

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

Do not administer more frequently than twice daily.

Adults

Allergic Conjunctivitis

Ophthalmic

Do not administer more frequently than twice daily.

Cautions for Ketotifen

Contraindications

• Known hypersensitivity to ketotifen or any ingredient in the formulation.

Warnings/Precautions

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats following oral administration. Cautious use is recommended.

Pediatric Use

Safety and efficacy not established in children <3 years of age.

Should not be used in children <3 years of age unless otherwise directed by a clinician.

Common Adverse Effects

Conjunctival injection, headaches, rhinitis. Some events may be related to the underlying ocular disease.

Ketotifen Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application to the eye.

Onset

Within minutes after topical application to the eye.

Stability

Storage

Ophthalmic

Solution

4–25°C.

Do not use if solution changes color or becomes cloudy.

Actions

• Suppresses the release of mediators from cells involved in hypersensitivity reactions and decreases chemotaxis and activation of eosinophils.

Advice to Patients

• Importance of learning and adhering to proper administration techniques to avoid contamination of the product.
• Importance of delaying insertion of contact lenses for at least 10 minutes after ketotifen instillation to prevent absorption of benzalkonium chloride by contact lenses.
• Not indicated for contact lens-related irritation.
• Importance of reporting new-onset eye pain or discomfort, visual disturbances, eye redness, worsening of itching, or itching lasting >72 hours.
• Importance of seeking quick medical attention if preparation is ingested orally.
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any other concomitant illnesses.
• Importance of informing patient of other important precautionary information. (See Cautions.)

Preparations

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

What is ketotifen ophthalmic?

Ketotifen ophthalmic (for the eyes) is used in adults and children at least 3 years old to temporarily treat itching of the eyes caused by allergy to dust, pollen, grass, animals, or other allergens.

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

Ketotifen ophthalmic 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.

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

• eye pain or changes in vision;
• eye itching that gets worse or lasts longer than 72 hours;
• severe burning, stinging, or eye irritation after using the eye drops; or
• signs of eye infection–swelling, redness, severe discomfort, crusting or drainage.

Less serious side effects may be more likely, and you may have none at all.

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

Warnings

Follow all directions on the label and package. Use exactly as directed.

Before taking this medicine

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

• eye irritation caused by wearing contact lenses.

Ask a doctor before using ketotifen ophthalmic if you are pregnant or breastfeeding.

Do not allow a young child to use ketotifen ophthalmic without help from an adult.

How should I use ketotifen ophthalmic?

Use exactly as directed on the label, or as prescribed by your doctor.

Do not use while wearing soft contact lenses. Ketotifen ophthalmic may contain a preservative that can permanently stain the lenses. Wait at least 10 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

To apply the eye drops: Pull down your lower eyelid to create a small pocket and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the prescribed number of drops.

Wait at least 5 minutes before using any other eye drops.

Do not touch the dropper tip or place it directly on your eye. A contaminated dropper can infect your eye and lead to serious vision problems.

Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Each single-use vial is for one use only (in both eyes). Store the unused vials in the original foil pouch and protect from light. Throw the vial away after one use, even if there is still medicine left inside.

Store at room temperature, in an upright position and tightly closed. Do not freeze.

Ketotifen ophthalmic dosing information

Usual Adult Dose for Allergic Conjunctivitis:

Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

Usual Pediatric Dose for Allergic Conjunctivitis:

Age: 3 years and older
Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

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?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medicine.

What should I avoid while using ketotifen ophthalmic?

Do not use other eye medications unless your doctor tells you to.

What is Kevzara?

Kevzara (sarilumab) is used to treat rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) in certain adults, and also active polyarticular juvenile idiopathic arthritis (pJIA) to help reduce pain, stiffness, swelling, and other symptoms.

Kevzara works by blocking the effects of a protein called interleukin-6 (IL-6), which is involved in causing inflammation, by blocking IL-6 reduces the inflammatory process and improves symptoms. Kevzara belongs to the class of medicines known as interleukin-6 receptor antagonists (also called IL-6 inhibitors) and is a type of biologic.

Kevzara is often given after other medications have been tried without successful treatment of symptoms, depending on the condition being treated. It is sometimes given together with other arthritis medicines.

Who can use Kevzara?

Kevzara FDA approval was received on May 22, 2017. It is now FDA approved to treat:

• active rheumatoid arthritis (moderate to severe) in adults who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
• polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
• active polyarticular juvenile idiopathic arthritis in patients who weigh 63 kg or greater.

Kevzara side effects

Common Kevzara side effects

Common Kevzara side effects may include runny or stuffy nose, sinus pain, sore throat, abnormal liver function tests, painful urination, or skin redness where an injection was given.

Serious Kevzara side effects

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

Serious and sometimes fatal infections may occur during treatment with Kevzara. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, body aches;
• cough with bloody mucus;
• feeling short of breath;
• diarrhea, stomach pain, weight loss;
• sores on your skin;
• pain or burning when you urinate; or
• feeling very tired.

Also call your doctor at once if you have signs of perforation (a hole or tear) in your stomach or intestines:

• fever;
• ongoing stomach pain; or
• a change in bowel habits.

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

Kevzara affects your immune system. You may get infections more easily, even serious or fatal infections. Tell your doctor if you have a fever, chills, tiredness, cough, diarrhea, stomach pain, weight loss, skin sores, or painful urination.

Kevzara may cause you to have a tear in your stomach or intestines. This is more likely if you have diverticulitis or a stomach ulcer, or if you also take steroids, methotrexate, or an NSAID (nonsteroidal anti-inflammatory drug). Call your doctor right away if you have a fever and ongoing stomach pain.

Before and during your treatment with Kevzara, you will need frequent blood tests. Your treatment may be delayed or stopped based on the results of these tests.

This medicine may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

Before taking this medicine

You should not use Kevzara if you are allergic to sarilumab.

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

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

• an active or chronic infection;
• diabetes;
• HIV or AIDS;
• a weak immune system;
• hepatitis or other liver problems;
• stomach pain, diverticulitis, or stomach or intestinal ulcers;
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using Kevzara may increase your risk of developing certain types of cancers. Ask your doctor about this risk.

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

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sarilumab on the baby.

You should not breast-feed while using Kevzara.

How should I take Kevzara?

Kevzara is injected under the skin, usually given once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

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

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

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

Store this medicine in its original container in a refrigerator. Protect from light. Do not shake or freeze the medicine. Keep Kevzara cold even while traveling.

Before injecting your dose, take the medicine out of the refrigerator and let it reach room temperature (for 30 minutes if using the prefilled syringe, or for 60 minutes if using the injection pen). Once at room temperature, the medicine must be used within 14 days.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

• Place used needles, syringes, or injection pens in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Adult Kevzara Dose for Rheumatoid Arthritis:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.
• Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.
• Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.
• Avoid use in patients with active infections.

Adult Kevzara Dose for Polymyalgia Rheumatica:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug is recommended to be used in combination with a tapering course of corticosteroids. It can be used as monotherapy following discontinuation of corticosteroids.

Kevzara Dose active polyarticular juvenile idiopathic arthritis

Usual recommended dose: 200 mg given subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater using the 200 mg/1.14 mL pre-filled syringe.

Comments:

• Can be used as monotherapy or in combination with conventional DMARDs.

Dose Modification

Dosage Modifications are required for cytopenias, abnormal liver enzymes, and infections. Click on the link below for more detailed dosage information.

Kevzara Dosage Forms

Single-dose pre-filled syringe injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

Single-dose pre-filled pen injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Do not receive a “live” vaccine while using Kevzara, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Kevzara?

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.

Tell your doctor about all your current medicines. Many drugs can interact with sarilumab, especially:

• any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or tofacitinib.

This list is not complete and many other drugs may affect Kevzara. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

• Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light.
• If needed, patients/caregivers may store this medicine at room temperature up to 77°F (25°C) up to 14 days in the outer carton. Do not store above 77°F (25°C). After removal from the refrigerator, use KEVZARA within 14 days or discard.
• Do not freeze.
• Do not shake.

Ingredients

Active Ingredient: sarilumab

Inactive Ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.

Company

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY U.S. License # 1752.

Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

Registered trademark: Sanofi Biotechnology ©2024 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC

Kevzara Biosimilars

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

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kevzara.Kevzara (sarilumab) – Sanofi-Aventis U.S. LLC

What is Keytruda?

Keytruda is used to treat multiple types of cancer such as melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin Lymphoma, urothelial carcinoma, gastric cancer, and many others. It is given as an infusion into your vein (IV infusion) every 3 to 6 weeks depending on the type of cancer you have.

Keytruda (pembrolizumab) is an immunotherapy treatment, not chemotherapy, although it is often used with other medicines, including chemotherapy. It works by enhancing the body’s natural immune response against cancer cells. 

Keytruda infusion first gained FDA approval on September 4, 2014.

Types of cancer treated with Keytruda

Keytruda is FDA-approved to treat numerous cancers, including certain types of:

• Biliary tract cancer
• Certain types of colorectal cancer
• Cervical cancer
• Classical Hodgkin Lymphoma
• Cutaneous squamous cell carcinoma (cSCC)
• Endometrial cancer
• Esophageal cancer
• Gastric cancer
• Head and neck squamous cell cancer (HNSCC)
• Kidney cancer (renal cell carcinoma)
• Liver cancer (Hepatocellular carcinoma [HCC]) secondary to hepatitis B
• Malignant pleural mesothelioma (MPM)
• Melanoma
• Merkel cell carcinoma (MCC)
• Microsatellite instability-high (MSI-H) or mismatch repair deficient cancers 
• Non-small cell lung cancer (NSCLC)
• Primary Mediastinal Large B-cell lymphoma (PMBCL)
• Triple-negative breast cancer
• Tumor mutational burden-high (TMB-H) cancer
• Urothelial cancer including some types of Bacillus Calmette-Guerin (BCG)-unresponsive urothelial cancers.

Some cancers may need to be tested for genetic markers such as PD-L1, dMMR, TMB, or pMMR to determine if Keytruda is right for you.

Note that this is just a summary, see the Keytruda Prescribing Information for specific criteria and prior treatment requirements that may apply for each indication. 

Mechanism

Keytruda works through a sophisticated mechanism of action called immune checkpoint inhibition:

• It blocks the PD-1 protein found on T cells
• This prevents PD-1 from interacting with PD-L1 on cancer cells
• This inhibition “takes the brakes off” the immune system, allowing T cells to recognize and attack cancer cells more effectively
• Keytruda enhances the immune system response against cancer.

Keytruda belongs to the drug class called immune checkpoint inhibitors and may also be called a monoclonal antibody.

Clinical trials have shown most people respond to Keytruda within 2-4 months of starting treatment .

Keytruda side effects

The most common side effects of Keytruda when it is used alone are:

• fatigue or excessive tiredness
• pain, including pain in the stomach, muscles, bones, or joints
• rash or itching
• diarrhea
• fever
• cough
• decreased appetite
• shortness of breath
• constipation
• nausea
• low levels of thyroid hormone.

Clinical trials have reported Keytruda side effects that are more common in children than adults are:

• fever
• vomiting
• headache
• stomach area pain
• low levels of white blood cells.

The most common side effects of Keytruda when it is used in combination with chemotherapy or radiotherapy treatments include:

• fatigue or excessive tiredness
• nausea
• constipation
• diarrhea
• decreased appetite
• rash
• vomiting
• cough
• trouble breathing
• fever
• hair loss
• inflammation of the nerves that may cause pain
• weakness and paralysis in the arms and legs
• swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
• mouth sores
• headache
• weight loss
• stomach-area (abdominal), joint, or muscle pain,
• trouble sleeping
• bleeding
• blisters, or rash on the palms of your hands and soles of your feet
• urinary tract infection
• low levels of thyroid hormone.
• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, weight loss
• low blood sodium levels, abnormal thyroid, liver and kidney function tests
• low blood cell counts
• tingling or numbness in your hands or feet, loss of movement in the arms and legs
• bleeding
• pain and burning when you urinate
• fever, headache, feeling weak or tired, dizziness, trouble sleeping
• cough, hoarse voice, feeling short of breath
• changes in your sense of taste, dry skin, and dry eyes
• itching, hair loss, rash, or blisters on your hands or feet
• increased blood pressure
• pain in your muscles, bones, or joints
• mouth sores or swelling around your mouth, nose, eyes, throat, intestines, or vagina
• tingling or numbness in your arms or legs.

Prompt medical attention to these side effects is crucial. Your doctor will monitor you during Keytruda treatment. 

Serious side effects and warnings

Keytruda is a medicine that works with your immune system to treat certain cancers. Keytruda can cause your immune system to attack normal organs and tissues in any area of your body and can cause serious side effects.

• These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time.
• These problems may happen anytime during treatment or even after your treatment has ended

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems, such as cough, shortness of breath, or chest pain
• Intestinal problems, such as:
  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems such as
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems, such as
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • eye sensitivity to light
  • hair loss
  • eye problems feeling cold
  • rapid heartbeat
  • constipation
  • increased sweating
  • your voice gets deeper
  • extreme tiredness
  • dizziness or fainting
  • weight gain or weight loss
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems, such as
  • decrease in your amount of urine
  • swelling of your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems, such as
  • rash
  • painful sores or ulcers in your mouth or your nose, throat, or genital area
  • itching
  • fever or flu-like symptoms
  • skin blistering or peeling
  • swollen lymph nodes.
• any new or worsening signs or symptoms in other organs, which 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, and bruising.
• Infusion reactions can sometimes be severe or life-threatening. Signs and symptoms may include:
  • chills or shaking dizziness
  • itching or rash
  • feeling like passing out
  • flushing
  • fever
  • shortness of breath or wheezing
  • back pain.

For people who have had an organ transplant, Keytruda may cause rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue 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 serious and can lead to death.

• These complications may happen if you underwent transplantation either before or after being treated with Keytruda.
• Your healthcare provider will monitor you for these complications.

Get emergency medical help if you have signs of an allergic reaction to Keytruda (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).

Keytruda may cause harm to an unborn baby. Females of reproductive potential should use effective contraception.

Getting medical treatment right away for these side effects may help keep these problems from becoming more serious. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

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

• an autoimmune disorder such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, lupus, or psoriasis
• received or plan to receive a stem cell transplant that uses donor stem cells
• had an organ transplant
• had radiation to your chest
• a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy

Keytruda may harm an unborn baby. Your healthcare provider will give you a pregnancy test to make sure you are not pregnant. Use effective birth control while using Keytruda and for at least 4 months after your last dose. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during
treatment with Keytruda.

Breastfeeding

It is not known if Keytruda passes into breast milk. Do not breastfeed while using this medicine and for at least 4 months after your last dose.

How is Keytruda administered?

Keytruda is administered as an infusion into your vein through an intravenous line over 30 minutes.

• In adults, a Keytruda infusion is usually given every 3 weeks or 6 weeks depending on the cancer type being treated and your dosage.
• In children, Keytruda is usually given every 3 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.

You will need frequent medical tests to help your doctor determine if you are tolerating Keytruda. Do not miss any follow-up visits.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda infusion.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving Keytruda?

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

What is Kineret?

Kineret is a FDA approved medicine used to treat moderate to severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children.
Kineret also has emergency use authorization (EUA) for the treatment of COVID-19 in specific hospitalized patients.

Kineret works to reduce the body’s immune response and inflammation by blocking the IL-1 receptor as it is an interleukin-1 (IL-1) receptor antagonist. 

Kineret is given as a subcutaneous injection daily or sometimes twice daily.

Kineret (anakinra) is used to control symptoms in: 

• Active rheumatoid arthritis that is moderate to severe, in adult patients who have tried disease modifying antirheumatic drugs (DMARDs) and they have not worked.
• Neonatal-onset multisystem inflammatory disease (NOMID) in new born babies. NOMID is a rare genetic condition that is a form of cryopyrin-associated periodic syndromes (CAPS). NOMID causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.
• Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children. DIRA is a very rare genetic condition that causes a severe inflammatory reaction during the first days of life and can lead to organ failure throughout the body.
• The US Food and Drug Administration (FDA) has authorized emergency use of anakinra for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

Warnings

The US Food and Drug Administration (FDA) has authorized emergency use of Kineret for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

You should not use Kineret if you are allergic to medicines that contain E. coli bacteria proteins, or if you have an active infection.

Before using Kineret, tell your doctor if you have asthma, kidney disease, a latex allergy, a weak immune system, an active or chronic infection, or signs of infection such as fever, chills, or open sores on your skin.

Kineret can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, mouth sores, weight loss, or feeling tired or short of breath.

You may have a higher risk of infection if you are also using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), adalimumab (Humira), cancer medicines, steroids, or medicines to prevent organ transplant rejection.

Do not give Kineret to anyone under 18 years old without medical advic

Before taking this medicine

You should not use Kineret if you are allergic to anakinra or if you have:

• an active infection; or
• an allergy to any medicine that contains E. coli bacteria proteins.

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

• kidney disease;
• an active or chronic infection;
• fever, chills, or open sores on your skin;
• a weak immune system (caused by disease or by using certain medicines):
• asthma;
• tuberculosis; or
• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or plan to become pregnant. Having rheumatoid arthritis or CAPS during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating rheumatoid arthritis or CAPS may outweigh any risks to the baby.

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

Do not give this medicine to a child without medical advice. Kineret is not approved to treat rheumatoid arthritis in anyone younger than 18 years old.

How should I use Kineret?

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

Kineret is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Kineret is given either once per day or once every other day. Follow your doctor’s dosing instructions very carefully. Inject your dose at the same time of day when you use the medicine.

Your healthcare provider will show you where on your body to inject Kineret. Use a different place each time you give an injection. Each injection should be given at least 1 inch away from where you last injected the medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Do not shake the prefilled syringe or you may ruin the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Call your doctor if your arthritis symptoms do not improve, or if they get worse while using Kineret.

Anakinra affects your immune system. You may get infections more easily. You will need frequent medical tests before and while using Kineret and for several months after you stop using it.

Store in the refrigerator, do not freeze. Protect from light. Throw away any unused medicine after the expiration date on the label has passed.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult Dose of Kineret for Rheumatoid Arthritis:

100 mg subcutaneously once daily at approximately the same time each day

Comments:
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: To reduce symptoms and slow the progression of structural damage in moderately to severely active rheumatoid arthritis (RA) in patients who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Usual Adult Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Usual Pediatric Dose of Kineret for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily
NOTE: Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Comments:
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Usual Pediatric Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

1 month and older:
Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in children 1 month and older

Usual dose of Kineret for adults with COVID-19:

Recommended dosage of Kineret is 100 mg administered daily by subcutaneous injection for 10 days.

Dose for patients with severe renal insufficiency or end stage renal disease  (creatinine clearance < 30 mL/min, estimated from serum creatinine levels) consider a dose of 100 mg of Kineret administered every other day for 5 total doses over 10 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Kineret?

Do not receive a “live” vaccine while using Kineret, or you could develop an infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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

Kineret side effects

Get emergency medical help if you have signs of an allergic reaction to Kineret: hives, sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness, fainting; swelling of your face, lips, tongue, or throat.

If you are using Kineret for DIRA, you may have an increased risk of allergic reactions, especially in the first weeks of treatment.

Call your doctor at once if you have:

• fever or chills;
• low white blood cell counts – mouth sores, skin sores, sore throat; or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Kineret side effects may include:

• abnormal liver function tests;
• rash;
• worsening arthritis symptoms;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• joint pain;
• flu symptoms;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• redness, bruising, itching, stinging, or swelling where the injection was given.

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 Kineret?

You may have a higher risk of infection from Kineret if you are also using:

• certolizumab;
• etanercept;
• golimumab;
• infliximab;
• adalimumab; or
• cancer medicines, steroids, or medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with anakinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Kineret Biosimilars

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

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kineret.Kineret (anakinra) – Swedish Orphan Biovitrum AB (publ)

What is Kisqali?

Kisqali is a  prescription medicine that may be used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults:

• in combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back
• that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer). Kisqali is used in combination with:
  • an aromatase inhibitor as the first endocrine-based therapy, or
  • fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy.

Kisqali’s mechanism of action involves blocking cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of the cell cycle. By blocking these enzymes, Kisqali slows or stops the growth of cancer cells. Kisqali is not chemotherapy, it is a targeted treatment. Kisqali is usually used in combination with hormone therapies, such as an aromatase inhibitor or fulvestrant (Faslodex).

• Aromatase inhibitors used in combination with Kisqali include letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin).
• Kisqali is available co-packaged with Femara as the Kisqali Femara Co-Pack.

Kisqali first gained FDA approval on March 13, 2017. Kisqali belongs to the drug class kinase inhibitors.

Kisqali side effects

The most common side effects of Kisqali in people with early breast cancer include:

• Changes in laboratory test results, such as decreased white blood cell counts, decreased red blood cell counts, increased liver function tests, decreased platelet counts, or increased kidney function tests
• infections
• nausea
• headache
• tiredness.

Other common side effects of Kisqali reported in people with advanced or metastatic breast cancer include:

• diarrhea
• vomiting
• constipation
• hair loss.

Serious side effects and warnings

Kisqali may cause the following serious side effects.

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

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

Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, skin pain or burning, blistering of the lips, eyes, or mouth, blisters on the skin or skin peeling, with or without fever.

Heart rhythm problems (QT prolongation). Kisqali can cause a heart problem known as QT prolongation This condition can cause an abnormal heartbeat and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with Kisqali.

• Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.

Liver problems. Kisqali can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with Kisqali. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark or brown (tea-colored) urine
• feeling very tired
• loss of appetite
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal.

Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with Kisqali and may result in infections that may be severe. Your healthcare provider should check your white blood cell counts before and during treatment with Kisqali. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking  Kisqali if you develop certain serious side effects during treatment with Kisqali.

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

Before taking

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

• have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
• have ever had a heart attack
• have a slow heartbeat (bradycardia)
• have high blood pressure that is not controlled
• have decreased thyroid gland function (hypothyroidism)
• have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
• have a fever, chills, or any other signs or symptoms of infection
• have liver problems
• have kidney problems
• are pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Kisqali can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Kisqali.

Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali.

Talk to your healthcare provider about birth control methods that may be right for you during this time.

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

Breastfeeding

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

Fertility in males

Kisqali may cause fertility problems in males, which may affect your ability to father a child. Talk to your healthcare provider if this is a problem for you.

How should I take Kisqali?

Take Kisqali exactly as your healthcare provider tells you. Do not change your dose or stop taking Kisqali without talking to your healthcare provider.

• Kisqali is usually taken 1 time a day for 21 days followed by 7 days of treatment.
  • This is called a cycle of treatment.
• Kisqali may be taken with or without food.
• Kisqali is usually taken in combination with an aromatase inhibitor or fulvestrant.
• Swallow Kisqali tablets whole. Do not chew, crush, or split Kisqali tablets before swallowing them.
• Take Kisqali each day at about the same time, preferably in the morning.
• Do not take any Kisqali tablets that are broken, cracked, or that look damaged.

Kisqali dosing

Kisqali Dosing for Early Breast Cancer

Kisqali dosing for Early Breast Cancer: Kisqali 400 mg orally (two 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.

Kisqali dosing for Advanced or Metastatic Breast Cancer: Recommended starting dose: Kisqali 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days without treatment.

Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability.

What happens if I miss a dose of Kisqali?

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

What other drugs will affect Kisqali?

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

• CYP3A Inhibitors: Avoid concomitant use of Kisqali with strong CYP3A inhibitors, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. If strong inhibitors cannot be avoided, reduce the dose of  Kisqali.
• CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, and glucocorticoids. Avoid concomitant use.
• CYP3A Substrates, such as midazolam, felodipine, buspirone, lovastatin, eletriptan, sildenafil, simvastatin, triazolam, dexamethasone, antipyrine, quinine: The dose of CYP3A substrates may need to be reduced when given concurrently with Kisqali.
• Drugs known to prolong the QT interval, such as haloperidol, ziprasidone, quetiapine, thioridazine, olanzapine, risperidone, droperidol, amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide, macrolides, fluoroquinolones. Avoid concomitant use of drugs known to prolong QT interval with Kisqali.

What is Kisunla?

Kisunla (donanemab) is a prescription medicine used for the mild dementia stage of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) due to Alzheimer’s disease. Kisunla is a plaque-targeting therapy that helps to slow down the decline in memory, thinking, and daily functioning. This slows the progression of Alzheimer’s disease so people can continue their daily activities and hobbies and live independently for a longer time. Kisunla is given as a once-monthly IV infusion.

Alzheimer’s disease symptoms are thought to be related to clumps of amyloid protein (amyloid plaques) that can occur in the brain. Kisunla is an amyloid plaque-targeting therapy that works by helping the body remove amyloid plaques in the brain, which slows the progression of Alzheimer’s disease.

Kisunla FDA approval was received on July 2, 2024, as a treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with mild dementia stage of AD, with confirmed amyloid pathology. Kisunla is an Eli Lilly and Company product.

How well does it work?

Kisunla (donanemab) significantly slowed Alzheimer’s disease progression by more than 20% at 76 weeks in the TRAILBLAZER-ALZ 2 clinical trial. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score in patients with low/medium tau and in the combined low/medium and high tau populations.

Treatment with Kisunla benefited all groups of trial participants, but patients in earlier stages of the disease showed the most significant improvements.

Kisunla side effects

Common Kisunla side effects

Common Kisunla side effects include headache and swelling in areas of the brain with or without small spots of bleeding in or on the brain’s surface. These occurred in at least 10% of patients and at a higher incidence compared to placebo.

Serious Kisunla side effects

• Serious allergic reactions include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.
• Infusion-related reactions. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you have symptoms of sweating, irritation of the skin, headache, nausea, chest pain, vomiting, or problems breathing during an infusion chills. If you have had an infusion-related reaction while receiving Kisunla, your healthcare provider may give you an antihistamine, acetaminophen, or a steroid before your infusions to decrease your risk of having an infusion reaction.

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

Kisunla can cause serious side effects, including:

Amyloid Related Imaging Abnormalities or ARIA.

ARIA is a common side effect that does not usually cause any symptoms, but sometimes serious symptoms can occur. ARIA can be fatal. It is most commonly seen in an MRI as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur.

Most people who develop ARIA do not have symptoms; however, some people may have symptoms such as headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.

If you have any of the symptoms of ARIA listed above, you should call your healthcare provider or go to the nearest hospital emergency room right away.

You are more at risk of ARIA if you have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers). Your healthcare provider may test to see if you have this risk factor.

If you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla, you may be at a higher risk of developing bleeding in the brain.

Magnetic resonance imaging (MRI) scans are done before and during your treatment to check you for ARIA.

You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.

Consider the risk of ARIA and the benefit of Alzheimer’s disease when deciding to treat with Kisunla.

Who should not take Kisunla?

You should not receive this medicine if you have had serious allergic reactions to donanemab-azbt or any of the ingredients in this infusion. See the end of this document for a complete list of ingredients.

Before taking this medicine

Pregnancy

Tell your healthcare provider if you plan to become pregnant, become pregnant, or are pregnant, as it is not known if this medicine will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if the active ingredient in Kisunla passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

How will I receive this medicine?

Kisunla is given as an infusion into a vein (IV infusion) in your arm, which will last about 30 minutes.
Kisunla is given every 4 weeks. If you miss an infusion, you should receive your next dose as soon as possible.

Kisunla Dosing information

Usual Adult Kisunla dose: 700 mg every four weeks for three doses, then 1400 mg every four weeks.

Comments

• Kisunla is given every four weeks as an intravenous infusion over approximately 30 minutes, it must be diluted prior to administration.
• Consider stopping dosing with Kisunla based on the reduction of amyloid plaques to minimal levels on amyloid PET imaging.
• If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

Kisunla is available as: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial.

Storage

Unopened Vial

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Keep the vial in the outer carton to protect it from light.

Do not freeze or shake.

If refrigeration is not available, it may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days.

Diluted Solution

After dilution, immediate use is recommended.

Diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.

Do not freeze the diluted solution.

Storage times include the duration of infusion.

Ingredients

Active ingredient: donanemab-azbt

Inactive ingredients: anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and Water for Injection, USP.

Manufacturer

Eli Lilly and Company, Indianapolis, IN 46285, USA

Kisunla Biosimilars

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

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kisunla.Kisunla (donanemab-azbt) – Eli Lilly and Company

What is Klisyri ointment?

Klisyri (tirbanibulin) ointment is a first-in-class microtubule inhibitor that may be used on the skin to treat actinic keratosis of the face or scalp. Actinic keratosis is a precancerous skin condition caused by damage from repeated exposure to ultraviolet light from the sun or indoor tanning.

Klisyri (tirbanibulin) targets tubulin which inhibits microtubule polymerization (a process that allows microtubules to adopt spatial arrangements that can change rapidly in response to cellular needs or sometimes to perform mechanical work), causing cell cycle arrest and cell death by apoptosis (a type of programmed cell death). This has an antiproliferative action (suppresses cell growth) and is thought to be the way that Klisyri works to clear actinic keratosis lesions.

Klisyri was FDA-approved on December 14, 2020.

Klisyri side effects

The most common side effects of Klisyri affecting 2% or more people include:

• local skin reactions, such as redness, flaking, or peeling
• itch at the site of the application
• pain at the site of application.

Warnings and serious side effects

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

Klisyri can cause serious side effects including:

• Eye irritation if Klisyri gets into the eye. Avoid transfer of the drug into the eyes or applying it around the eye area. If accidental exposure occurs, flush your eyes with water and seek medical care
• Severe local skin reactions can occur, such as blisters, pus, ulcers, or skin breakdown in the treated area. Do not start using Klisyri until your skin has healed from any previous drug or surgical treatment. Call your doctor at once if you have severe skin irritation or swelling. Some redness, flaking, scaling, or peeling of treated skin is to be expected.

It is not known if Klisyri ointment is safe and effective in children less than 18 years of age.

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

Before taking this medicine

Tell your doctor about all other medicines or treatments you are receiving to treat actinic keratosis. You may need to delay starting Klisyri until your skin has healed from other treatments. Also, tell your doctor:

• if you have other skin problems in the areas you will treat with this medicine
• are pregnant or intending to become pregnant
• are breastfeeding.

Pregnancy

There is no data on the use of Klisyri during pregnancy, but animal studies using many times the recommended dosage have shown an association with birth defects. Talk to your doctor about the risks versus benefits of using Klisyri during pregnancy.

Breastfeeding

It is not known if Klisyri passes into human milk. Talk to your doctor about the best way to feed your baby if you are breastfeeding.

How should I use Klisyri ointment?

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

Use Klisyri only on the face or scalp and only on the skin areas affected by actinic keratosis.

• Do not take it by mouth or put it near your eyes. Rinse with water if this medicine gets in your mouth or on your lips. Wipe away from your eyes if it gets near your eyes.

Klisyri is usually applied once per day for 5 days in a row. Follow your doctor’s dosing instructions very carefully.

• Apply a thin layer of Klisyri to the affected area only enough Klisyri ointment to cover the skin area affected by actinic keratosis.
• Do not cover the treated skin area with a bandage.
• Avoid washing or touching the treated skin for at least 8 hours after applying this medicine.
• Wash your hands with soap and water after applying this medicine.

Klisvri dosing information

• Each single dose packet of Klisyri is for one day use. Throw away the packet after use, even if there is still medicine left inside.
• Use another packet from the carton for the next day.
• Apply Klisvri for 5 days in a row then stop applying it.
• Only apply to affected areas on the face and scalp. Avoid the eyes, mouth, and nostrils.

There is enough Klisyri in a 1-unit dose packet to cover up to 25 cm² treatment field on the face or balding scalp.

Each carton of Klisyri contains 5 single-dose packets. Use one packet a day for 5 consecutive days. Throw away each packet after use, do not save for the next day.

What to avoid

Do not use Klisyri ointment in, around, or near your eyes, mouth, or lips. If contact does occur, rinse with water and call your doctor right away.

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

What happens if I miss a dose?

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

What is Klonopin?

Klonopin is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). It is thought that benzodiazepines work by enhancing the activity of certain neurotransmitters in the brain.

Klonopin is used to treat certain seizure disorders (including absence seizures or Lennox-Gastaut syndrome) in adults and children.

Klonopin is also used to treat panic disorder (including agoraphobia) in adults.

Warnings

Klonopin can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF CLONAZEPAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Never share Klonopin with another person. Selling or giving away this medicine is against the law.

Some people have thoughts about suicide while taking Klonopin. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Get medical help right away if you stop using Klonopin and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not stop using Klonopin without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Before taking this medicine

You should not take Klonopin if you have:

• narrow-angle glaucoma;
• severe liver disease; or
• a history of allergic reaction to any benzodiazepine (clonazepam, alprazolam, diazepam, lorazepam, Valium, Xanax, Versed, and others).

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

• kidney or liver disease;
• breathing problems;
• depression, mood problems, or suicidal thoughts or behavior; or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Some people have thoughts about suicide while taking Klonopin. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or plan to become pregnant. If you use Klonopin during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not start or stop seizure medication during pregnancy without your doctor’s advice. Clonazepam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

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

Do not give this medicine to a child without medical advice. Klonopin is not approved to treat panic disorder in anyone younger than 18 years old.

How should I take Klonopin?

Take Klonopin exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Klonopin in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Swallow the tablet whole, with a full glass of water.

Clonazepam doses are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.

Your doctor will need to check your progress on a regular basis.

Call your doctor if this medicine seems to stop working as well in treating your seizures or panic attacks.

Do not stop using Klonopin without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

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 at 1-800-222-1222. An overdose of clonazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, or coma.

What should I avoid while taking Klonopin?

Do not drink alcohol. Dangerous side effects or death could occur.

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

Klonopin side effects

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

Clonazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• new or worsening seizures;
• severe drowsiness;
• weak or shallow breathing;
• unusual changes in mood or behavior;
• confusion, paranoia, nightmares, hallucinations;
• thoughts of suicide or hurting yourself;
• unusual or involuntary eye movements.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Klonopin side effects may include:

• drowsiness, dizziness;
• feeling tired or depressed;
• memory problems; or
• problems with walking or coordination.

What is Klor-Con?

Klor-Con contains potassium chloride, a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

Klor-Con is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.

Klor-Con is available as effervescent tablets, extended release tablets, extended release capsules (sprinkle), and powder for oral solution.

Warnings

You should not use Klor-Con if you have high levels of potassium in your blood (hyperkalemia), or if you also take a “potassium-sparing” diuretic.

To be sure Klor-Con is helping your condition, your blood may need to be tested often. Your heart rate and rhythm may also be checked using an electrocardiogram or ECG (sometimes called an EKG) to measure electrical activity of the heart. Do not miss any scheduled appointments.

Serious side effects of potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or mouth.

Do not stop taking Klor-Con without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

Do not crush, chew, break, or suck on an extended-release tablet or capsule. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Sucking on a potassium tablet can irritate your mouth or throat. Take Klor-Con with food or just after a meal.

Before taking this medicine

You should not use Klor-Con if you are allergic to potassium chloride, or if:

• you have high levels of potassium in your blood (hyperkalemia); or
• you take a “potassium-sparing” diuretic (water pill) such as amiloride, spironolactone, or triamterene.

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

• heart problems;
• high blood pressure;
• liver or kidney disease;
• a large tissue injury such as a severe burn;
• an electrolyte imbalance (such as low levels of calcium or magnesium in your blood);
• trouble swallowing;
• slow digestion;
• stomach bleeding, an ulcer, or a blockage in your stomach or intestines;
• an adrenal gland disorder;
• diabetes; or
• severe dehydration.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Klor-Con?

Take Klor-Con 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.

Take Klor-Con with food if the medicine upsets your stomach.

Always follow directions on the medicine label about giving this medicine to a child.

Take the tablet or capsule with a full glass of water.

Do not crush, chew, or suck on a potassium tablet or capsule. Sucking on the pill could irritate your mouth or throat.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Mix the oral solution with least 4 ounces of water before taking it.

You may need to follow a special diet while using Klor-Con. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

Call your doctor if you have trouble swallowing a Klor-Con capsule or tablet. You may be able to dissolve the tablet in water, or mix the medicine from a capsule with soft food. Carefully follow your doctor’s instructions.

You may need frequent medical tests. Your heart function may need to be checked using an electrocardiogram or ECG (sometimes called an EKG). Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include stomach pain, vomiting, irregular heartbeats, chest pain, muscle weakness, loss of movement, numbness or tingling, or feeling light-headed.

What should I avoid while taking Klor-Con?

Do not use potassium supplements or other products that contain potassium, unless your doctor has told you to. Salt substitutes or low-salt foods often contain potassium. Read the label of any food or medicine to see if it contains potassium.

Klor-Con side effects

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

Stop using Klor-Con and call your doctor at once if you have:

• severe throat irritation;
• chest pain, trouble breathing;
• stomach bloating, severe vomiting, severe stomach pain;
• high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Klor-Con side effects may include:

• nausea, vomiting, diarrhea;
• gas, stomach pain; or
• the appearance of a Klor-Con tablet in your stool.

What is Koselugo?

Koselugo is used to treat neurofibromatosis type 1 (NF1) in children aged 2 and older with plexiform neurofibromas that cannot be completely removed by surgery. It is an oral capsule that is taken 2 times a day.

Koselugo (selumetinib) gained FDA approval on April 10, 2020. There is no generic.

How does Koselugo work?

Koselugo’s mechanism of action involves blocking the actions of 2 enzymes, MEK1 and 2. These proteins are critical components of signalling pathways involved in cell growth and division. Clinical trials have shown this medication reduces the number, volume, and spread of neurofibroma tumors.

Koselugo (selumetinib)  belongs to the drug class called multikinase inhibitors.

Side effects

The most common side effects of Koselugo are:

• nausea, vomiting, stomach pain;
• itching;
• dry skin, acne, rash;
• redness around your fingernails;
• feeling weak or tired;
• mouth pain or soreness, swollen gums;
• muscle or bone pain;
• headache; or
• fever.

Diarrhea is a common side effect of this medicine. Tell your doctor right away the first time you have diarrhea while taking Koselugo.

Serious side effects and warnings

Koselugo may cause the following serious side effects:

• Heart problems. Clinical trials have shown that Koselugo can lower the amount of blood pumped by your heart, which is common and can also be severe. Your healthcare provider will do tests before and during treatment with Koselugo to check how well your heart is working. Tell your healthcare provider right away if you get any of the following signs or symptoms:
  • persistent coughing or wheezing
  • shortness of breath
  • swelling of your ankles and feet
  • tiredness
  • increased heart rate.
• Eye problems. Koselugo can cause eye problems that can lead to blindness. Your healthcare provider will check your vision before and during treatment with Koselugo. Tell your healthcare provider right away if you get any of the following signs or symptoms:
  • blurred vision
  • loss of vision
  • dark spots in your vision (floaters)
  • other changes to your vision.
• Severe diarrhea. Diarrhea is common with Koselugo and can also be severe. Tell your healthcare provider right away the first time that you get diarrhea during treatment with Koselugo. Your healthcare provider may give you medicine to help control your diarrhea and may tell you to drink more fluids.
• Skin rash. Skin rashes are common with Koselugo and can also be severe. Tell your healthcare provider if you get any of the following signs or symptoms:
  • a rash that covers a large area of your body
  • peeling skin
  • blisters.
• Muscle problems (rhabdomyolysis). Muscle problems are common with Koselugo and can also be severe. Treatment with Koselugo may increase levels of an enzyme in your blood called creatine phosphokinase (CPK) which may be a sign of muscle damage. Your healthcare provider should do a blood test to check your blood levels of CPK before you start taking Koselugo and during treatment. Tell your healthcare provider right away if you get any of the following signs or symptoms:
  • muscle aches or pain
  • muscle spasms and weakness
  • dark, reddish urine.

Drug interactions. Tell your healthcare provider if you take aspirin, blood thinners, or other medicines to treat blood clots. Koselugo contains vitamin E, which may increase your risk of bleeding.

Your healthcare provider may change your dose, temporarily stop, or permanently ask you to stop taking Koselugo if you have any of these side effects.

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

Before taking

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

• have heart problems
• have eye problems
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Koselugo should not be given to a child younger than 2 years old.

Pregnancy

Koselugo can harm an unborn baby. Your healthcare provider should check to see if you are pregnant before you begin treatment with Koselugo. Females who can become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after their last dose.

Males with female partners who can become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after their last dose.

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

Breastfeeding

It is not known if Koselugo passes into your breast milk. Do not breastfeed during treatment with Koselugo and for 1 week after your last dose. Talk to your healthcare provider about how to feed your baby during this time.

How should I take Koselugo?

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

• Koselugo is a capsule that is taken 2 times a day.
• Can be taken with or without food.
• Take each dose at the same time each day, about 12 hours apart.
• Take with a full glass of water.
• Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if your child has trouble swallowing the capsule whole.

After taking

If you vomit shortly after taking Koselugo, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Tell your doctor if you start having loose stools (diarrhea). You may be given anti-diarrhea medicine. Keep using this medicine for as long as your doctor has prescribed.

• Drink plenty of liquids if you have diarrhea.

Koselugo can cause your heart to pump less blood than normal. Your heart function will need to be checked every 3 to 6 months while you are taking this medicine.

Koselugo can also cause eye problems that may lead to blindness. You will need frequent vision exams, and your next dose may be delayed based on the results.

Dosing information

Your healthcare provider decides the correct dose for you based on body surface area (height and weight). Your dose needs may change if you gain or lose weight, or if you are still growing.

• Do not change your dose or dosing schedule without your doctor’s advice.

Usual dose for children 2 years and older for NF1:

• Koselugo 25 mg/m² orally 2 times a day (approximately every 12 hours) until disease progression or unacceptable toxicity.

Reduce the recommended dosage to 20 mg/m² orally 2 times a day for patients with moderate hepatic impairment (Child-Pugh B).

• The dosage for use in patients with severe hepatic impairment (Child-Pugh C) has not been established.