The indications for Voranigo are clear, mainly targeting patients with grade 2 astrocytomas or oligodendrogliomas who have undergone surgery, including biopsy, partial or complete resection, and who have susceptible IDH1 or IDH2 mutations.

1、 Drug name

1. Common name: vorasidenib

2. Product Name: VORANIGO ®

2、 Indications

Wolassidni is suitable for the treatment of grade 2 astrocytomas or oligodendrogliomas with IDH1 or IDH2 mutations diagnosed after surgery (including biopsy, partial or total resection) in adult and pediatric patients aged 12 years and above.

3、 Specifications and characteristics

40mg tablets: white to off white oval shaped tablets, with black "40" printed on one side and blank on the other side.

4、 Main components

Each tablet contains the active ingredient vorasidenib, which is 10mg or 40mg respectively. The excipients include cross-linked carboxymethyl cellulose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and sodium dodecyl sulfate. The coating ingredients include hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, and titanium dioxide. Printing ink contains black iron oxide, hydroxypropyl methylcellulose, and propylene glycol.

5、 Usage and dosage

1. The recommended dosage for adults is 40mg orally once daily.

2. Pediatric patients aged 12 and above should be given 40mg once daily for those weighing ≥ 40kg and 20mg once daily for those weighing<40kg.

3. Can be taken with food or on an empty stomach. The whole tablet should be swallowed and should not be broken, crushed, or chewed.

6、 Dose adjustment

If adverse reactions occur, the dosage should be adjusted according to the severity:

1. Adult or pediatric patients weighing ≥ 40kg: The first dose should be reduced to 20mg once daily, and the second dose should be reduced to 10mg once daily.

2. Pediatric patients weighing less than 40kg: Reduce to 10mg once daily for the first time.

3. If unable to tolerate 10mg once daily, the medication needs to be permanently discontinued.

4. The specific adjustment plan should be executed based on the severity of liver dysfunction or other adverse reactions.

7、 Medication precautions

1. Medication time: Take medication at approximately the same time every day.

2. Leakage treatment: If the leakage time is within 6 hours, it should be replenished as soon as possible; If it exceeds 6 hours, skip the dose and take the next dose according to the original plan.

3. Vomiting treatment: If vomiting occurs after taking the medication, there is no need to take it again. Take the medication the next day according to the original plan.

4. Dietary impact: Both high-fat and low-fat meals may increase drug absorption, and it is recommended to maintain consistent medication habits.

8、 Medication for special populations

1. Pregnant women: may cause fetal damage and require effective non hormonal contraceptive measures.

2. Breastfeeding women: Breastfeeding is prohibited during the treatment period and within 2 months after the last dose.

3. Fertility population: May affect male and female fertility, contraceptive measures should be taken until 3 months after the last dose.

4. Elderly patients: Data is limited and should be used with caution.

5. Patients with liver and kidney dysfunction: mild to moderate liver injury or creatinine clearance rate>40mL/min do not require dose adjustment; Patients with severe liver injury or renal insufficiency need to be closely monitored for adverse reactions.

9、 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, elevated AST, elevated GGT, and decreased neutrophils.

3. Serious adverse reactions may include liver toxicity and require regular monitoring of liver function.

10、 Contraindications

There are currently no clear contraindications.

11、 Drug interactions

1. Avoid co administration with strong or moderate acting CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin.

2. Avoid simultaneous use with intermediate acting CYP1A2 inducers (such as phenytoin, rifampicin) and smoking.

3. Avoid co administration with CYP3A substrate drugs as it may reduce their efficacy.

4. Hormonal contraceptives may have reduced effectiveness, and it is recommended to use non hormonal contraceptive methods.

12、 Storage method

1. Stored at 20 ° C-25 ° C (68 ° F-77 ° F), short-term storage between 15 ° C-30 ° C (59 ° F-86 ° F) is allowed.

2. The medicine bottle contains a desiccant, please do not take it out or swallow it.

3. Keep the bottle cap difficult for children to open.

13、 Manufacturer

Produced by Servier Pharmaceuticals LLC

Voranigoinformation