Voranigo is an isocitrate dehydrogenase-1/2 (IDH1/2) inhibitor, indicated for the treatment of patients aged 12 years and older with IDH1/2-mutant grade 2 astrocytoma or oligodendroglioma.

How to Use Voranigo

Routine Dosing Regimen

Adult patients: 40mg orally once daily, until disease progression or unacceptable toxicity occurs.

Pediatric patients aged ≥12 years: 40mg daily for those with a body weight ≥40kg; 20mg daily for those with a body weight <40kg.

Administration method: Swallow the tablet whole. It can be taken with or without food. Do not split, chew, or crush the tablet.

Management of Missed Doses and Vomiting

Missed dose: If the time since the missed dose is <6 hours, take the missed dose immediately; if it exceeds 6 hours, skip the missed dose and take the next dose as scheduled the next day.

Vomiting: If vomiting occurs after taking the medication, do not take an additional dose. Take the regular dose as usual the next day.

Dose Adjustment of Voranigo

Management of Hepatic Toxicity

Monitoring requirements: Periodically monitor ALT/AST/GGT and bilirubin before and during treatment.

First 2 months: Monitor once every 2 weeks.

Subsequent 2 years: Monitor once a month.

Adjustment principle: For ALT/AST >3-5 times the upper limit of normal (ULN): Temporarily discontinue the medication for the first occurrence until recovery to ≤Grade 1, then resume at the original dose; if it recurs, dose reduction is required.

For ALT/AST >5-20 times ULN: Temporarily discontinue the medication, and after recovery, permanent dose reduction is necessary (for adults/patients ≥40kg, reduce to 20mg/day for the first time, and to 10mg/day for the second time).

With bilirubin elevation or ALT/AST >20 times ULN: Discontinue the medication permanently.

Management of Other Adverse Reactions

For Grade ≥3 non-hepatic toxic reactions: For the first occurrence, temporarily discontinue the medication until recovery to ≤Grade 1, then resume at a reduced dose; if it recurs, discontinue the medication permanently.

Use of Voranigo in Special Populations

Patients with Hepatic or Renal Impairment

Mild/moderate hepatic impairment (Child-Pugh A/B): No dose adjustment is required.

Severe hepatic impairment (Child-Pugh C): Close monitoring for adverse reactions is necessary.

Renal impairment (CrCl >40mL/min): No dose adjustment is required; patients with CrCl ≤40mL/min or those on dialysis require enhanced monitoring.

Children and Elderly Patients

Children aged ≥12 years: Dose adjustment based on body weight (see Routine Dosing Regimen), and efficacy is extrapolated from adult data.

Elderly patients (aged ≥65 years): Limited data are available, and individualized assessment is required.

Pregnancy and Lactation

Pregnant women: The drug has embryo-fetal toxicity. Pregnancy status must be confirmed before medication use. Effective non-hormonal contraceptive measures should be used during treatment and for 3 months after discontinuing the medication.

Lactation: Breastfeeding is prohibited during treatment and for 2 months after the last dose.