Enasidenib

Generic name: Enasidenib
Brand names: Idhifa
Dosage form: oral tablet (100 mg; 50 mg)
Drug class: Miscellaneous antineoplastics

Usage of Enasidenib

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.

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--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.
  • Common side effects of enasidenib 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.

    Before taking Enasidenib

    You may need to have a negative pregnancy test before starting this treatment.

    Both men and women using enasidenib should use birth control to prevent pregnancy. Enasidenib can harm an unborn baby if the mother or father is using this medicine.

    Keep using birth control for at least 2 months after your last dose. Tell your doctor right away if a pregnancy occurs.

    Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

    Relate drugs

    How to use Enasidenib

    Usual Adult Dose for Acute Myeloid Leukemia:

    100 mg orally once a day with or without foodDuration 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.

    Warnings

    Seek medical help right away if you have symptoms of differentiation syndrome within 10 days to 5 months after taking enasidenib. Symptoms include fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

    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.

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