Olutasidenib

Generic name: Olutasidenib
Brand names: Rezlidhia
Dosage form: oral capsule (150 mg)
Drug class: Miscellaneous antineoplastics

Usage of Olutasidenib

OlUTAsidenib is used to treat acute myeloid leukemia (AML) in adults with a specific gene mutation called isocitrate dehydrogenase-1 (IDH1).

Olutasidenib is given after other treatments did not work or stopped working.

Your doctor will perform tests to make sure olutasidenib is the right treatment for you.

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

Olutasidenib 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.

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.

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

nausea, constipation, diarrhea, vomiting, stomach pain or mouth sores; or

liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of olutasidenib may include:

abnormal blood tests;

nausea, diarrhea, constipation, mouth sores;

joint pain;

rash;

shortness of breath; or

tiredness, not feeling well, fever.

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.

Before taking Olutasidenib

Tell your doctor if you have ever had:

liver problems.

Olutasidenib may harm an unborn baby. Tell your doctor if you are pregnant.

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

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How to use Olutasidenib

Usual Adult Dose for Acute Myeloid Leukemia:

Initial dose: 150 mg orally twice daily on an empty stomachDuration of therapy: Until disease progression or unacceptable toxicityComments:-Patients are screened for this treatment based on the presence of Isocitrate dehydrogenase-1 (IDH1) mutations in blood or bone marrow.-FDA-approved tests for the detection of IDH1 mutation in acute myeloid leukemia (AML) are available at http://www.fda.gov/CompanionDiagnostics.-If there is no instance of unacceptable toxicity or progressive disease during treatment, continue the treatment for 6 months to allow for clinical response.Use: Treatment of relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation

Warnings

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 other drugs will affect Olutasidenib

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

Other drugs may affect olutasidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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