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Ivosidenib

Generic Name: Ivosidenib (EYE voe SID e nib)
Brand Name: Tibsovo

Medically reviewed on Sep 5, 2018

Warning

  • A health problem called differentiation syndrome has happened with ivosidenib. This may cause liver, kidney, or other organ problems and can be deadly if not treated. Call your doctor right away if you have bone pain, cough, a fever, shortness of breath or other breathing problems, sudden weight gain, swelling in the arms or legs, or swollen gland. Call your doctor right away if you have signs of kidney problems like not able to pass urine, change in how much urine is passed, or blood in the urine; signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes; or signs of low blood pressure like dizziness or passing out.

Uses of Ivosidenib:

  • It is used to treat a type of leukemia.

What do I need to tell my doctor BEFORE I take Ivosidenib?

  • If you have an allergy to ivosidenib or any part of ivosidenib.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Itraconazole or ketoconazole.
  • If you are taking rifampin.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not breast-feed while you take ivosidenib or for 1 month after you stop ivosidenib.

This is not a list of all drugs or health problems that interact with ivosidenib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ivosidenib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ivosidenib?

  • Tell all of your health care providers that you take ivosidenib. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You will need an ECG before starting ivosidenib and during treatment. Talk with your doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking ivosidenib.
  • This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust to prevent pregnancy while taking ivosidenib.
  • If you are pregnant or you get pregnant while taking ivosidenib, call your doctor right away.

How is this medicine (Ivosidenib) best taken?

Use ivosidenib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Avoid taking ivosidenib with high-fat meals.
  • Swallow whole. Do not chew, break, or crush.
  • Take ivosidenib at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking ivosidenib as you have been told by your doctor or other health care provider, even if you feel well.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Weakness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in senses like being able to see, touch, hear, or taste.
  • Change in balance.
  • Swelling.
  • Chest pain.
  • Fever.
  • Patients with cancer who take ivosidenib may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with ivosidenib. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of Ivosidenib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Muscle or joint pain.
  • Loose stools (diarrhea).
  • Upset stomach or throwing up.
  • Mouth irritation or mouth sores.
  • Belly pain.
  • Cough.
  • Hard stools (constipation).
  • Not hungry.
  • Headache.
  • Pimples (acne).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ivosidenib?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ivosidenib is refilled. If you have any questions about ivosidenib, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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