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enasidenib (Idhifa)

Brand Names: Idhifa

Generic Name: enasidenib

What is enasidenib (Idhifa)?

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. This medicine 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.

What are the possible side effects of enasidenib (Idhifa)?

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:

Common side effects may include:

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.

What is the most important information I should know about enasidenib (Idhifa)?

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.

What should I discuss with my healthcare provider before taking enasidenib (Idhifa)?

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 this medicine 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 (Idhifa)?

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.

QUESTION

What is leukemia? See Answer

What happens if I miss a dose (Idhifa)?

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 (Idhifa)?

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

What should I avoid while taking enasidenib (Idhifa)?

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

What other drugs will affect enasidenib (Idhifa)?

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.

Where can I get more information (Idhifa)?

Your pharmacist can provide more information about enasidenib.


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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Reviewed on 1/21/2021

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