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Tibsovo

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

Medically reviewed on Nov 11, 2018

What is Tibsovo?

See also: Xospata

Tibsovo (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.

Tibsovo is used to treat acute myeloid leukemia (AML) in adults with an IDH1 mutation. This medicine is used when AML has come back or has not improved with prior treatment.

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

Important Information

Tibsovo 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.

Before taking this medicine

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

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

  • heart disease;

  • long QT syndrome (in you or a family member);

  • nerve problems; or

  • an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood).

Ivosidenib may harm an unborn baby. Use a barrier form of birth control (condom or diaphragm with spermicide) to prevent pregnancy while you are using Tibsovo. 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.

You should not breast-feed while using this medicine, and for at least 1 month after your last dose.

How should I take Tibsovo?

Take Tibsovo exactly as it was prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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 Tibsovo.

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 Tibsovo, 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.

Tibsovo dosing information

Usual Adult Dose for Acute Myeloid Leukemia:

500 mg orally once daily until disease progression or unacceptable toxicity; for patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

Comments:
-NOTE: Select patients for the treatment of AML based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during therapy and at relapse.

Use: For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test

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 Tibsovo?

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

Tibsovo side effects

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

Tibsovo 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 Tibsovo.

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 Tibsovo 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 Tibsovo?

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 interact with 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.

Further information

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

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

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