Enasidenib is used to treat acute myeloid leukemia (AML) in adults with an IDH2 mutation. enasidenib is used when AML has come back or has not improved with prior treatment.

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

Seek medical help right away if you have symptoms of differentiation syndrome within 10 days to 5 months after taking enasidenib. Symptoms include fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

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

Drink plenty of liquids while you are taking enasidenib.

Take with or without food, at the same time each day

Do not crush, chew, or break an enasidenib tablet. Swallow it whole.

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

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the canister of moisture-absorbing preservative.

Usual Adult Dose for Acute Myeloid Leukemia:

100 mg orally once a day with or without food

Duration of Therapy:
-Treat until disease progression or unacceptable toxicity.
-For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Comments: Select patients based on the presence of isocitrate dehydrogenase-2 (IDH2) mutations in the blood or bone marrow as detected by an FDA-approved test, http://www.fda.gov/CompanionDiagnostics.

Use: Treatment of relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using enasidenib should use birth control to prevent pregnancy. Enasidenib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 2 months after your last dose. Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

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). Do not remove the desiccant (a small packet included with medication to absorb moisture) from the container.

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.

Drink plenty of water or other fluids every day during your treatment with enasidenib,

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.

Enasidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 10 days to 5 months after you start taking enasidenib.

Seek medical help right away if you have symptoms of differentiation syndrome:

• fever, cough, trouble breathing;

• bone pain;

• rapid weight gain; or

• swelling in your arms, legs, underarms, groin, or neck.

Call your doctor at once if you have any of these side effects:

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe or ongoing vomiting or diarrhea; or

• signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects of enasidenib may include:

• nausea, vomiting, diarrhea;

• loss of appetite; or

• jaundice.

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.

Other drugs may affect enasidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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

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.