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Generic Name: enasidenib
Dosage Form: Tablets
Date of Approval: August 1, 2017
Company: Celgene Corporation

Treatment for: Acute Myeloid Leukemia

FDA Approves Idhifa

The U.S. Food and Drug Administration has approved Idhifa (enasidenib), an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Idhifa may cause serious side effects, including:

  • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells which may be lifethreatening or lead to death if not treated. Differentiation syndrome has happened within 10 days and up to 5 months after starting treatment. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment:
    • fever
    • cough
    • shortness of breath
    • swelling of arms and legs
    • swelling around neck, groin, or underarm area
    • fast weight gain (greater than 10 pounds within a week)
    • bone pain
    If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine taken by mouth or given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.

What is Idhifa?

Idhifa is a prescription medicine used to treat people with acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation whose disease has come back or has not improved after previous treatment(s).

It is not known if this medicine is safe and effective in children.

Before starting treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or plan to become pregnant. Idhifa can cause harm to your unborn baby if taken during pregnancy.
    • If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start taking Idhifa.
    • Females who are able to become pregnant and who take Idhifa should use effective birth control (contraception) during treatment and for at least one month after your last dose.
    • Males who have female partners that are able to become pregnant should use effective birth control during treatment and for at least one month after your last dose.
    • Idhifa may affect how hormonal contraceptives work and may cause them to not work as well.
    • Talk to your healthcare provider about birth control methods that may be right for you during treatment.
    • Idhifa may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
  • Are breastfeeding or plan to breastfeed. It is not known if Idhifa passes into your breast milk. You should not breastfeed during your treatment and for at least one month after your last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Idhifa?

  • Take Idhifa exactly as your healthcare provider tells you to.
  • Take Idhifa one time a day at the same time each day.
  • Swallow the tablets whole. Do not chew or split the tablet.
  • Swallow the tablets with 8 ounces (one cup) of water.
  • The tablets can be taken with or without food.
  • If you miss a dose or vomit after taking a dose, take the dose as soon as possible on the same day. Then take your next dose the next day at your regularly scheduled time. Do not take two doses at the same time to make up for the missed dose.
  • Your healthcare provider should do blood tests to check your blood counts before you start treatment and at a minimum of every two weeks for at least the first three months during treatment to check for side effects.

Idhifa side effects

Idhifa may cause serious side effects, including:

See Important information.

The most common side effects include:

  • nausea
  • vomiting
  • diarrhea
  • jaundice
  • decreased appetite

Tell your healthcare provider if you have any changes to the color of your skin or the whites of your eyes.

Your healthcare provider will monitor you for side effects during treatment and may tell you to stop taking Idhifa if you develop certain side effects.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Idhifa?

  • Store tablets at room temperature from 68°F to 77°F (20°C to 25°C).
  • Store tablets in the original container.
  • Keep the container tightly closed with desiccant canister inside to protect the tablets from moisture.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Idhifa

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take this medicine for conditions for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Idhifa?

Active ingredient: enasidenib

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose acetate succinate, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide

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