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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®
Volasidenib is suitable for the treatment of grade 2 astrocytoma or oligodendroglioma carrying IDH1 or IDH2 mutations in adults and children aged 12 years and above who have been diagnosed after surgery (including biopsy, partial resection or total resection).
40 mg tablets: White to off-white oval tablets, with black "40" printed on one side and blank on the other side.
Each tablet contains the active ingredient vorasidenib, which is 10mg or 40mg respectively. Excipients include: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating ingredients include hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide. Printing ink contains black iron oxide, hypromellose and propylene glycol.
1. The recommended dose for adults is 40 mg orally once a day.
2. Pediatric patients aged 12 years and above should be dosed according to body weight: 40 mg once a day for those ≥40kg; 20mg once a day for those <40kg.
3. It can be taken with food or on an empty stomach. The tablet must be swallowed whole and cannot be broken, crushed or chewed.
If adverse reactions occur, the dose needs to be adjusted according to the severity:
1. Adults or pediatric patients ≥40kg: reduce the dose to 20mg once a day for the first time, and reduce the dose to 10mg once a day for the second time.
2. Pediatric patients <40kg: reduce the dose to 10mg once a day for the first time.
3. If you cannot tolerate 10 mg once a day, you need to permanently stop taking the drug.
4. The specific adjustment plan needs to be implemented according to the severity of abnormal liver function or other adverse reactions.
1. Medication time: Take the medication at approximately the same time every day.
2. Treatment of missed doses: If the missed dose is within 6 hours, the dose should be taken as soon as possible; if it exceeds 6 hours, skip the dose and take the next dose as originally planned.
3. Treatment of vomiting: If you vomit after taking the medicine, there is no need to take a supplement, and you can take the medicine the next day as originally planned.
4. Dietary effects: High-fat or low-fat meals may increase drug absorption, so it is recommended to maintain consistent medication habits.
1. Pregnant women: It may cause fetal damage, so effective non-hormonal contraceptive measures need to be taken.
2. Breastfeeding women: Breastfeeding is prohibited during treatment and within 2 months after the last dose.
3. Fertility groups: It may affect male and female fertility. Contraceptive measures need to be taken for 3 months after the last dose.
4. Elderly patients: The data are limited and should be used with caution.
5. Patients with hepatic and renal insufficiency: No dosage adjustment is required for patients with mild to moderate liver damage or creatinine clearance >40mL/min; patients with severe liver damage or severe renal insufficiency need to be closely monitored for adverse reactions.
1. Common adverse reactions (≥15%) include: Fatigue, headache, COVID-19 infection, musculoskeletal pain, diarrhea, nausea, and epileptic seizures.
2. Laboratory abnormalities include: Elevated ALT, increased AST, increased GGT, and neutropenia.
3. Serious adverse reactions may include: Liver toxicity, liver function needs to be monitored regularly.
There are currently no clear contraindications.
1. Avoid combined use with strong or moderate CYP1A2 inhibitors (such as fluvoxamine, ciprofloxacin).
2. Avoid simultaneous use with moderate CYP1A2 inducers (such as phenytoin, rifampicin) and smoking.
3. Avoid combination with CYP3A substrate drugs, as their efficacy may be reduced.
4. The effectiveness of hormonal contraceptives may be reduced, so it is recommended to use non-hormonal contraceptive methods.
1. Store at 20°C–25°C (68°F–77°F). Short-term storage is allowed between 15°C–30°C (59°F–86°F).
2. The medicine bottle contains desiccant, please do not take it out or swallow it.
3. Keep the bottle cap difficult for children to open.
Produced by ServierPharmaceuticalsLLC