Voranigo Prescribing Information

▼ Voranigo^® film coated tablets

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

Refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Film-coated tablets, 10 mg of vorasidenib, 40 mg of vorasidenib.

Indication: Treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.

Dosage and Administration: Posology: The recommended dose of Voranigo in adults is 40 mg taken orally once daily. For adolescent patients 12 years of age and older weighing at least 40 kg the recommended dose is 40 mg taken orally once daily and 20 mg taken orally once daily for patients weighing less than 40 kg. Dose adjustments: Maximum of 3 dose reductions to a minimum of 10 mg once daily based on safety and tolerability. Consult SmPC for dose interruption/resumption and reduction criteria. Administration: Tablets taken with water. No food should be eaten 2 hours before and 1 hour after taking tablets. Hepatic and Renal impairment: No adjustment of starting dose required in mild or moderate hepatic or renal impairment. Not recommended in pre-existing severe hepatic impairment. Elderly: ≥ 65 years – No adjustment of starting dose.

Contraindications: Hypersensitivity to vorasidenib or any excipients.

Warnings and Precautions: Hepatotoxicity: Voranigo should not be used in patients with preexisting severe hepatic impairment (Child-Pugh class C). Elevations in liver enzymes, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN), with elevation in total bilirubin > 2 times the ULN have been reported in patients treated with vorasidenib. Liver enzymes (including ALT, AST and gammaglutamyl transferase (GGT)) and total bilirubin must be monitored prior to starting treatment, every 2  weeks during the first 2 months of treatment and then monthly for the first 2 years of treatment, and as clinically indicated thereafter. Consider weekly monitoring for ALT or AST elevations ≤ 3 times the ULN. Withhold, reduce dose or permanently discontinue treatment based on the severity of the liver enzyme abnormalities  Contraception: Women of child-bearing potential/men with partner of child-bearing potential must use effective contraceptive measures during treatment and for at least 3 months after the last dose. Pregnancy and lactation: Should not be used during pregnancy. Breastfeeding should be discontinued during treatment and for at least 2 months after the last dose. Fertility: Patients who wish to conceive a child should be advised to seek reproductive counselling prior to starting treatment Renal impairment: The pharmacokinetics and safety have not been studied in patients with renal impairment (eGFR ≤ 40 mL/min/1.73 m2) or renal impairment requiring dialysis. Voranigo should be used with caution in these patients. Lactose intolerance: Voranigo contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Paediatric population: Use in children less than 12 years of age is not recommended.

Interactions: Concomitant use of strong or moderate CYP1A2 inhibitors should be avoided and consider alternative therapies that are not strong inhibitors of CYP1A2 during treatment with Voranigo. Concomitant use of vorasidenib with smoking tobacco may decrease vorasidenib plasma concentrations which may reduce the anti-tumor activity of vorasidenib. Concomitant use of Cytochrome P450 (CYP) substrates of these enzymes with narrow therapeutic index should be avoided in patients taking Voranigo.  Consider alternative therapies that are not sensitive substrates of these enzymes during treatment. BCRP substrates: Caution should be exercised when administering Voranigo with BCRP substrates (including, but not limited to, rosuvastatin), since Voranigo is an inhibitor of BCRP. Hormonal contraceptives: Voranigo may decrease concentrations of hormonal contraceptives, therefore, concomitant use of a barrier method of contraception is recommended during treatment and for at least 3 months after the last dose.

Side Effects: Very common: Platelet count decreased, abdominal pain, diarrhoea, alanine aminotransferase, aspartate aminotransferase and gammaglutamyl transferase increased, and fatigue. Common: Hyperglycaemia, decreased appetite, hypophosphataemia, and alkaline phosphatase increased.

NHS Price: Voranigo 10mg x 30 film-coated tablets £7500, Voranigo 40 mg x 30 film-coated tablets £15,000. Legal Category: POM. Product Licence Numbers: Voranigo 10mg film-coated tablet (PL 05815/0122), Voranigo 40mg film-coated tablets (PL 05815/0123). Further Information: Servier Laboratories Ltd., Sefton Park, Stoke Poges, SL2 4JS, Tel (01753) 666409. Date of Revision: September 2025