💊 Indications
Ivosenib is indicated for the treatment of adult patients with:
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Acute Myeloid Leukemia (AML): In combination with azacitidine for newly diagnosed AML with a susceptible IDH1 mutation in patients who are 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy.
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Relapsed or Refractory AML: As monotherapy for adult patients with relapsed or refractory AML with an IDH1 mutation.
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Cholangiocarcinoma: For previously treated, locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with an IDH1 mutation.
📦 Dosage and Administration
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Dosage: The recommended dose is 500 mg (two 250 mg tablets) taken orally once daily.
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Administration: Ivosenib can be taken with or without food. Tablets should be swallowed whole and not split, crushed, or chewed. Treatment should continue until disease progression or unacceptable toxicity occurs.
⚠️ Side Effects and Precautions
Common Side Effects:
Serious Side Effects:
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Differentiation Syndrome: A potentially life-threatening condition characterized by fever, cough, difficulty breathing, rash, and rapid weight gain. Immediate medical attention is required if symptoms occur.
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QTc Prolongation: Changes in the heart's electrical activity that can lead to serious heart rhythm problems. Regular monitoring with ECGs is recommended.
Precautions:
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Pregnancy and Lactation: Ivosenib may cause harm to an unborn baby. Women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. Breastfeeding is not recommended during treatment and for 1 month after the last dose.Medicines.org.uk
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Drug Interactions: Ivosidenib may interact with other medications, including hormonal contraceptives. Patients should inform their healthcare provider about all medications they are taking.
📦 Packaging
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Formulation: Film-coated tablets
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Strength: 250 mg of Ivosidenib per tablet
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Packaging: Each bottle contains 60 tablets.
