Idhifa

Generic name: Enasidenib
Drug class: Miscellaneous antineoplastics

Usage of Idhifa

Idhifa 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.

Idhifa is used to treat acute myeloid leukemia in adults with an IDH2 mutation.

Idhifa is used when AML has come back or has not improved with prior treatment.

Idhifa side effects

Get emergency medical help if you have signs of an allergic Reaction to Idhifa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Idhifa 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 Idhifa.

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, decreased urination, tingling in your hands and feet or around your mouth.
  • Common Idhifa 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.

    Before taking Idhifa

    You should not use Idhifa if you are allergic to Enasidenib.

    Before using Idhifa 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 Idhifa. 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. Idhifa use by either parent may cause birth defects.

    Keep using birth control for at least 2 months after your last dose of Idhifa. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enasidenib.

    Idhifa 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.

    Relate drugs

    How to use Idhifa

    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.

    Warnings

    Idhifa 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 this medicine.

    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 other drugs will affect Idhifa

    Other drugs may interact with 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.

    Disclaimer

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