Olutasidenib (oh-loo-ta-SID-e-nib)

Treats acute myeloid leukemia (AML).

Brand Name(s):

Rezlidhia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.
• Swallow the capsule whole. Do not break, open, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • If you miss a dose and it is less than 8 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 8 hours or more until your next dose, take the missed dose then go back to your regular schedule. Do not take 2 doses within 8 hours.
  • If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines may affect how olutasidenib works. Tell your doctor if you are using rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have liver disease.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• This medicine may cause the following problems:
  • Differentiation syndrome, which may be life-threatening
  • Liver problems
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling of your arms or legs
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Joint or muscle pain
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088