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

Suitable for the treatment of IDH1 or IDH2 mutant grade 2 astrocytomas or oligodendrogliomas in adult and pediatric patients aged 12 years and above, requiring surgery (including biopsy, subtotal resection, or total resection) before use.

3、 Specifications and characteristics

40mg tablets

4、 Main components

1. Active ingredient: Valasini (existing in the form of citric acid hemihydrate eutectic).

2. The auxiliary materials include cross-linked carboxymethyl cellulose sodium, magnesium stearate, microcrystalline cellulose, etc. The coating contains hydroxypropyl methylcellulose, lactose, etc.

5、 Usage and dosage

1. Adults: Take 40mg orally once a day.

2. Pediatric patients weighing ≥ 40kg: same dosage as adults; Pediatric patients weighing less than 40kg: 20mg orally once daily.

3. Usage: Swallow the whole tablet, it can be taken with food or on an empty stomach.

6、 Dose adjustment

1. Hepatotoxicity treatment: Adjust the dosage according to the grading of ALT/AST elevation. If there is a grade ≥ 3 elevation for the first time, medication should be suspended and reduced after recovery; If there is a recurrence, the medication will be permanently discontinued.

2. Other adverse reactions: If a grade ≥ 3 non hepatotoxic reaction occurs for the first time, it should be paused and reduced. If it recurs, the medication should be permanently discontinued.

7、 Medication precautions

1. Missed dose: Supplement within 6 hours, skip this dose if it exceeds 6 hours, and take the medication normally the next day.

2. Vomiting: No need for supplementation, take the medication according to the original plan the next day.

3. Dietary impact: A high-fat diet may significantly increase the peak blood drug concentration, and it is recommended to maintain a regular medication schedule.

8、 Medication for special populations

1. Pregnancy/lactation: with embryo fetal toxicity, prohibited during pregnancy; Non hormonal contraceptive measures should be taken during the medication period and within 3 months of discontinuation. Prohibited during lactation.

2. Liver and kidney dysfunction: Mild to moderate liver damage does not require dose adjustment, while severe liver damage or glomerular filtration rate ≤ 40mL/min requires close monitoring.

3. Children: Safe and effective for ages ≥ 12, insufficient data for ages<12.

9、 Adverse reactions

Common symptoms (≥ 15%) include fatigue (37%), headache (28%), COVID-19 infection (28%), musculoskeletal pain (24%), diarrhea (21%), nausea (20%), and epileptic seizures (16%). The laboratory abnormalities mainly include elevated ALT (9%) and elevated AST (4.8%).

10、 Contraindications

There are no clear contraindications.

11、 Drug interactions

1. CYP1A2 inhibitors/inducers: Avoid using strong/medium acting CYP1A2 inhibitors (such as fluvoxamine) or medium acting inducers (such as phenytoin) in combination.

2. Hormonal contraceptive pills: may reduce contraceptive effectiveness and require switching to non hormonal contraceptive methods.

12、 Storage method

Store at room temperature of 20 ° C-25 ° C, with desiccants inside the bottle, and keep in the original packaging.

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