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.

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.

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 discontinued if you have certain side effects.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Acute Myeloid Leukemia:

Initial dose: 150 mg orally twice daily on an empty stomach
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-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

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to olutasidenib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.