ALIENSIDIPINE

COMPOSITION
Enasidenib mesylate………………………………50mg
INDICATION
For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
PACKAGING: 30 tablets/bottle.
Reg No: 11 L 1273/24
Download ALIENSIDIPINE Drug Registration Certificate

Brand name: ALIENSIDIPINE


Composition:
Each tablet contains:
Enasidenib mesylate………………………………50mg


Indications:
For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.


Dosage:
• 100 mg orally once daily, with or without food.
• Treat until disease progression or unacceptable toxicity occurs.
• For patients without unacceptable toxicity or disease progression, treat for a minimum of 6 months to allow time for clinical response.
• Swallow tablets whole. Do not chew, split, or crush tablets. Administer tablets orally about the same time each day.


Contraindications: None.


Warnings:
• Patients treated with Enasidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
• Embryo-Fetal Toxicity: Enasidenib can cause fetal harm. Advise patients of the potential risk to a fetus and use effective contraception.
• Certain CYP1A2, CYP2C19, CYP3A, OATP1B1, OATP1B3 and BCRP Substrates:Avoid concomitant use unless otherwise recommended in the Prescribing Information.


Adverse Effects: Noninfectious leukocytosis, diarrhea, nausea, vomiting, decreased appetite, elevated bilirubin, tumor lysis syndrome, and differentiation syndrome.


Dosage form: Pale yellow oval-shaped film-coated tablet.


Expiry date: 24 months from the date of manufacture.


Packaging: 30 tablets/bottle.


Storage:
• Store sealed in original packaging between 20°C-25°C, in a dry place.
• Keep out of reach of children.


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