IDHIFA

Generic Name/API: enasidenib

Manufacturer: Bristol-Myers Squibb

Dosage Forms & Strength & Pack Size:
Tablets: 50 mg or 100 mg

Storage:
Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Store and dispense in the original bottle (with a desiccant canister) to protect from moisture.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

WHAT IS IDHIFA® (enasidenib)?

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 IDHIFA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IDHIFA?

IDHIFA may cause serious side effects, including:

  • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened within 1 day and up to 5 months after starting IDHIFA. 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 with IDHIFA:
    • 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.

Before taking IDHIFA, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant, plan to become pregnant, or think you might be pregnant during treatment with IDHIFA. 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 should use effective birth control (contraception) during treatment with IDHIFA and for 2 months after your last dose of IDHIFA
    • IDHIFA may affect how hormonal contraceptives work and may cause them to not work as well. You should use an effective non-hormonal contraceptive method during treatment with IDHIFA and for 2 months after your last dose of IDHIFA if you use hormonal contraceptives.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with IDHIFA.
    • Males who have female partners that are able to become pregnant should use effective birth control during treatment with IDHIFA and for at least 2 months after your last dose of IDHIFA
    • Talk to your healthcare provider about birth control methods that may be right for you during treatment with IDHIFA
    • 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 with IDHIFA and for 2 months after your last dose of IDHIFA

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 1 time a day at the same time each day. IDHIFA can be taken with or without food
  • Swallow IDHIFA tablets whole with 8 ounces (one cup) of water. Do not chew, split, or crush the IDHIFA tablets
  • If you miss a dose of IDHIFA or vomit after taking a dose of IDHIFA, take the dose of IDHIFA as soon as possible on the same day. Then take your next dose the next day at your regularly scheduled time. Do not take 2 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 IDHIFA treatment and at a minimum of every 2 weeks for at least the first 3 months during treatment to check for side effects

What are the possible side effects of IDHIFA?

IDHIFA may cause serious side effects, including:

See “What is the most important information I should know about IDHIFA?”

The most common side effects of IDHIFA 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 of IDHIFA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 IDHIFA for conditions for which it was not prescribed. Do not give IDHIFA 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 about IDHIFA that is written for health professionals.

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