Olutasidenib

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

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

Your doctor will conduct tests to ensure that olutasidenib is the appropriate treatment for you.

Olutasidenib may also be used for other reasons not mentioned in this medication guide.

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

Take olutasidenib twice a day (12 hours apart) around the same time every day.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

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

If you vomit shortly after taking olutasidenib, do not take another dose. Take your next dose as scheduled.

You will need medical tests before and during treatment with olutasidenib.

Your treatment may be changed or permanently stopped if you have certain side effects.

Store at room temperature away from moisture and heat.

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.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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.

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

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses within 8 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Sometimes, it is not safe to use certain medicines together. Some drugs can change how much of other drugs are in your blood, which might increase side effects or make the medicines less effective.

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