IDHIFA 50MG /100MG TAB (ENASIDENIB)

What is 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.

🔹 Manufacturer

• Original Developer: Agios Pharmaceuticals

• Marketed By: Celgene Corporation (now a subsidiary of Bristol Myers Squibb)

💊 Dosage Forms and Strengths

• Formulation: Film-coated tablets

• Available Strengths:

  • 50 mg: Pale yellow, oval-shaped tablets debossed with “ENA” on one side and “50” on the other

  • 100 mg: Pale yellow, capsule-shaped tablets debossed with “ENA” on one side and “100” on the other

• Packaging: Bottles containing 30 tablets, equipped with a desiccant to maintain tablet integrity

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.

📌 Indication

Idhifa is indicated for the treatment of adult patients with relapsed or refractory AML who have a confirmed IDH2 mutation, as detected by an FDA-approved test.

🧪 Mechanism of Action

Enasidenib is an inhibitor of the mutated IDH2 enzyme. In AML patients with IDH2 mutations, the enzyme produces an abnormal metabolite called 2-hydroxyglutarate (2-HG), which impedes normal cell differentiation. By inhibiting mutant IDH2, enasidenib reduces 2-HG levels, promoting the differentiation of leukemic cells into normal blood cells.

⚠️ Safety and Precautions

• Differentiation Syndrome: A potentially life-threatening condition characterized by symptoms such as fever, cough, shortness of breath, rapid weight gain, and swelling. Immediate medical attention and corticosteroid therapy are essential if this syndrome is suspected.

• Common Side Effects: Nausea, vomiting, diarrhea, jaundice (yellowing of the skin or eyes), and decreased appetite.

• Pregnancy and Breastfeeding: Idhifa may cause harm to a developing fetus or newborn. Women who are pregnant or breastfeeding should not take this medication.