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The indications for Voranigo are clear, mainly for patients with grade 2 astrocytoma or oligodendroglioma who have undergone surgery, including biopsy, partial resection or complete resection, and these patients have susceptible IDH1 or IDH2 mutations.
1. Generic name: Vorasidenib (Vorasidenib)
2. Trade name: VORANIGO®
It is suitable for the treatment of IDH1 or IDH2 mutant grade 2 astrocytoma or oligodendroglioma in adults and children aged 12 years and above, which requires surgery (including biopsy, subtotal resection or total resection).
40 mg tablet
1. Active ingredient: Vorasidil (exists in the form of citric acid hemihydrate eutectic).
2. Excipients include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, etc., and the coating contains hypromellose, lactose, etc.
1. Adult : Take 40 mg orally once a day.
2. Pediatric patients ≥40kg : Same as adult dosage; <40kg pediatric patients : 20mg orally once daily.
3. How to take : Swallow the whole tablet with food or on an empty stomach.
1. Treatment of hepatotoxicity :Adjust the dose according to the grade of ALT/AST elevation. If an increase of grade ≥3 occurs for the first time, the medication needs to be suspended and the dose reduced after recovery; if the medication recurs, the medication should be permanently discontinued.
2. Other adverse reactions : If a non-hepatotoxic reaction of grade ≥3 occurs for the first time, the drug should be suspended and the dose reduced. If it recurs, the drug should be permanently discontinued.
1. Missed dose of : Take it within 6 hours. If it exceeds 6 hours, skip this dose and take the medicine normally the next day.
2. Vomiting : There is no need to take additional doses. Take the medicine as originally planned the next day.
3. Effect of diet on : A high-fat diet may significantly increase the peak blood drug concentration. It is recommended to maintain a regular medication schedule.
1. Pregnancy/breastfeeding : It has embryo-fetal toxicity and is contraindicated in pregnancy; non-hormonal contraceptive measures must be taken during medication and within 3 months of discontinuation. Not allowed during lactation.
2. Hepatic and renal insufficiency : No dose adjustment is required for mild to moderate liver damage. Patients with severe liver damage or glomerular filtration rate ≤40mL/min need to be closely monitored.
3. Children : It is safe and effective for ≥12 years old, but there is insufficient data for <12 years old.
Common (≥15%) include fatigue (37%), headache (28%), COVID-19 infection (28%), musculoskeletal pain (24%), diarrhea (21%), nausea (20%) and epileptic seizure (16%). Laboratory abnormalities mainly include elevated ALT (9%), elevated AST (4.8%), etc.
There are no clear contraindications.
1. CYP1A2 inhibitor/inducer : Avoid the combined use of strong/moderate CYP1A2 inhibitors (such as fluvoxamine) or moderate inducers (such as phenytoin).
2. Hormonal contraceptive : It may reduce the contraceptive effect, so you need to switch to non-hormonal contraceptive methods.
Store at room temperature 20°C-25°C. The bottle contains desiccant and must be kept in the original packaging.