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Enasidenib

Generic Name: enasidenib (EN a SID a nib)
Brand Name: Idhifa

Medically reviewed by Drugs.com on Sep 11, 2018 – Written by Cerner Multum

What is enasidenib?

Enasidenib 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.

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.

Important Information

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.

Before taking this medicine

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

Before using enasidenib 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 enasidenib. 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 enasidenib whether you are a man or a woman. Enasidenib use by either parent may cause birth defects.

Keep using birth control for at least 1 month after your last dose of enasidenib. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

This medicine 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.

How should I take enasidenib?

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

Enasidenib 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 enasidenib.

You may take enasidenib with or without food.

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

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

If you vomit shortly after taking enasidenib, take another dose as soon as possible. Then take your next dose at the regularly scheduled time.

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.

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

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking enasidenib?

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

Enasidenib side effects

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--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common 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.

Enasidenib dosing information

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.

What other drugs will affect enasidenib?

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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