Enasidenib (en-a-SID-a-nib)

Treats acute myeloid leukemia (AML).

Brand Name(s):

Idhifa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole with 1 cup (8 ounces) of water. Do not crush, break, or chew it.
• Take this medicine at the same time each day.
• 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 or vomit after taking a dose of this medicine, take the missed dose as soon as possible on the same day, and then go back to your regular dosing schedule. Do not take 2 doses at the same time to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store this medicine in its original container.

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 food and medicines can affect how enasidenib works. Tell your doctor if you are using caffeine, dextromethorphan, digoxin, midazolam, omeprazole, or rosuvastatin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Women should use another form of birth control (including condoms or spermicide) along with your pills during treatment and for at least 2 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 2 months after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 2 months after the last dose.
• This medicine may cause the following problems:
  • Differentiation syndrome (which may be life-threatening)
  • Increase risk of tumor lysis syndrome
• 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.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Bone pain
• Change in how much or how often you urinate, cloudy urine
• Chest pain, trouble breathing, cough, cold sweat, bluish-colored skin
• Diarrhea, nausea, vomiting, unusual tiredness
• Rapid weight gain, swelling in your hands, ankles, or feet
• Yellow eyes or skin

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

• Decreased appetite

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