Idhifa targets a specific gene mutation called IDH2, which can affect your bone marrow. IDH2 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia.

Idhifa is used to treat acute myeloid leukemia in adults with an IDH2 mutation.

Idhifa is used when AML has come back or has not improved with prior treatment.

Idhifa 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 this medicine.

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.

Before taking this medicine

You should not use Idhifa if you are allergic to enasidenib.

Before using Idhifa tell your doctor about all your medical conditions or allergies.

You may need to have a negative pregnancy test before starting this treatment. In animal studies, enasidenib caused miscarriage, low birth weight, stillbirth, and birth defects.

Enasidenib may harm an unborn baby. Use a barrier form of birth control (condom or diaphragm with spermicide) to prevent pregnancy while you are using Idhifa. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

You should use birth control to prevent pregnancy while using this medicine whether you are a man or a woman. Idhifa use by either parent may cause birth defects.

Keep using birth control for at least 2 months after your last dose of Idhifa. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

Idhifa may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because enasidenib may harm the baby if a pregnancy does occur.

It is not known whether enasidenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 1 month after your last dose.

Take Idhifa exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Idhifa exactly as prescribed by your doctor. Idhifa is usually given once per day. Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking this medicine.

You may take this medicine with or without food.

Do not crush, chew, or break a tablet. Swallow the tablet whole.

Idhifa is usually given until your body no longer responds to the medication.

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

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

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 should not use Idhifa if you are allergic to enasidenib.

Before using Idhifa tell your doctor about all your medical conditions or allergies.

You may need to have a negative pregnancy test before starting this treatment. In animal studies, enasidenib caused miscarriage, low birth weight, stillbirth, and birth defects.

Enasidenib may harm an unborn baby. Use a barrier form of birth control (condom or diaphragm with spermicide) to prevent pregnancy while you are using Idhifa. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

You should use birth control to prevent pregnancy while using this medicine whether you are a man or a woman. Idhifa use by either parent may cause birth defects.

Keep using birth control for at least 2 months after your last dose of Idhifa. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

Idhifa may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because enasidenib may harm the baby if a pregnancy does occur.

It is not known whether enasidenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 1 month 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.

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 to Idhifa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Idhifa 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 Idhifa.

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, decreased urination, tingling in your hands and feet or around your mouth.

Common Idhifa side effects 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 interact with 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.