Alert

ivosidenib

Pronunciation: EYE voe SID e nib

Brand: Tibsovo

What is the most important information I should know about ivosidenib?

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

What is ivosidenib?

Ivosidenib targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia (AML).

Ivosidenib is used to treat AML in adults with an IDH1 mutation. Your doctor will test you for this gene. Ivosidenib is used when other treatments did not work or have stopped working.

Ivosidenib is also used in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems.

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

What should I discuss with my healthcare provider before taking ivosidenib?

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

Tell your doctor if you have ever had:

  • heart disease;
  • long QT syndrome (in you or a family member);
  • cirrhosis or other liver disease;
  • kidney disease (or if you are on dialysis);
  • nerve problems; or
  • an electrolyte imbalance (such as low levels of calcium, potassium, sodium, or magnesium in your blood).

Ivosidenib may harm an unborn baby. Tell your doctor right away if you become pregnant.

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

This medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because ivosidenib can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

How should I take ivosidenib?

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

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

Take the medicine at the same time each day, with or without food.

Drink plenty of liquids while you are taking ivosidenib.

Do not take ivosidenib with foods that are high in fat, such as butter, bacon, cheese, or whole milk.

If you vomit shortly after taking ivosidenib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. 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.

What should I avoid while taking ivosidenib?

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

What are the possible side effects of ivosidenib?

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

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

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

  • fever, cough, trouble breathing;
  • dizziness;
  • rash;
  • decreased urination;
  • rapid weight gain; or
  • swelling in your arms or legs.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath;
  • sudden dizziness (like you might pass out);
  • low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
  • nervous system problems --numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Common side effects may include:

  • nausea, diarrhea, constipation;
  • fever, tiredness;
  • cough, shortness of breath;
  • sores in your mouth or throat;
  • anemia;
  • joint pain; or
  • swelling in your arms or legs.

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 at 1-800-FDA-1088.

What other drugs will affect ivosidenib?

Ivosidenib 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.

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

Where can I get more information?

Your pharmacist can provide more information about ivosidenib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 2.01. Revision date: 5/10/2019.

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