Section 14 · Monograph
Vorasidenib
Reviewed Nov 2026FDA label
VoranigoIDH1/IDH2 inhibitor
- Forms
- Tab: 10, 40mg
- Dose
- Adults: 40mg once daily | Age 12+: 40mg (40kg or more) or 20mg (under 40kg) once daily; Grade 2 IDH1/2-mutant glioma
- MOA
- Blocks mutant IDH enzymes, ↓2-HG production
Indications
- Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery, in adults and pediatric patients 12 years and olderFDA-labeled
Mechanism of Action
- Oral dual inhibitor of mutant IDH1 and IDH2 enzymes, reducing the oncometabolite 2-hydroxyglutarate (2-HG) and restoring cellular differentiation
Full Dosing
Adult / usual
- Adults: 40mg orally once daily until progression or unacceptable toxicity
- Dose reductions for toxicity: 20mg then 10mg daily (adults); discontinue if 10mg is not tolerated
- Swallow tablets whole; do not split, crush or chew
Pediatric
- Pediatric age 12+: 40mg daily if 40kg or more; 20mg daily if under 40kg
Contraindications
- None listed in labeling
Drug Interactions
- Strong CYP1A2 inhibitors (e.g., fluvoxamine) increase exposure — avoid
- CYP1A2 inducers (smoking, rifampin) reduce exposure
- May reduce effectiveness of hormonal contraceptives — use non-hormonal contraception
Adverse Effects
- Hepatotoxicity (ALT/AST elevations)
- Fatigue, headache, infections
- Musculoskeletal pain, diarrhea, nausea
- Seizures
Monitoring Parameters
- Liver tests (ALT, AST, GGT, bilirubin) before starting and at frequent intervals early in therapy per label, then periodically
Pregnancy & Lactation
- Embryo-fetal toxicity; effective non-hormonal contraception during and after treatment per label
- Breastfeeding not recommended