Description
Vorasidenib Tablets 40mg
Each film-coated tablet contains Vorasidenib hemicitric acid hemihydrate 50.16 mg equivalent to Vorasidenib……40 mg
INDICATION
LuciVora is an isocitrate dehydrogenase -1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and old er with Grade 2 astrocytoma or oligodendroglioma with a susceptible I DH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
DOSAGE AND USE
• Recommended dosage in adults: 40 mg orally once daily • Recommended dosage in pediatric patients 12 years of age and older based on body weight: ≥40 kg: 40 mg orally once daily, <40 kg: 20 mg orally once daily. • Take with or without food.
SIDE EFFECT
The most common ( ≥15%) adverse reactions include fatigue, headache, COVID -19, musculoskeletal pain, diarrhea, nausea, and seizure. Grade 3 or 4 ( ≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.
WARNING
• Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose or discontinue LuciVora based on severity. • Embryo-Fetal Toxicity: LuciVora can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception.
STORAGE
Store at 20℃to 25℃, in a dry place.
PRESENTATION
Each film-coated tablet contains V orasidenib 40 mg, 30 tablets/ bottle. Keep out of reach of Children and in a dry place.
MANUFACTURED AND MARKETED BY
LUCIUS PHARMACEUTICALS(LAO) CO., LTD Thongmang village, Xaythany district, Vientiane Capital, Laos
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