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vorasidenib

Voranigo · ATC code L01XM04

Key facts
Active substance
vorasidenib
ATC code
L01XM04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Voranigo 10 mg film-coated tablets / Voranigo 40 mg film-coated tablets
Marketing authorisation holder
Les Laboratoires Servier
Information as of
2026-10-28

Key facts

Vorasidenib (Voranigo) is an oral inhibitor of mutant isocitrate dehydrogenase (IDH1/IDH2) used to treat Grade 2 astrocytoma and oligodendroglioma with an IDH mutation.

What it is used for

  • Monotherapy for predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adults and adolescents aged 12 years and older weighing at least 40 kg who only had surgery and are not in immediate need of radiotherapy or chemotherapy.
  • The IDH mutation must be confirmed with an appropriate test before starting.

Dosing

  • 40 mg once daily (12 years and older, at least 40 kg), as long as clinical benefit is observed and treatment is tolerated.
  • Dose reductions for adverse reactions: 20 mg once daily, then 10 mg once daily; details for liver toxicity see the full text.
  • Take a missed dose within 6 hours, otherwise skip it; no replacement tablet after vomiting.
  • Blood counts and liver tests before starting, every 2 weeks for the first 2 months and monthly for the first 2 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Hepatotoxicity including serious cases of hepatic failure, hepatic necrosis and acute hepatitis; withhold, reduce or discontinue depending on severity.
  • A carcinogenicity risk cannot be excluded based on animal findings.
  • Effect on hormonal contraceptives not investigated; use a barrier method as well.

Side effects

  • Most common: ALT increased (59.3%), AST increased (45.5%), GGT increased (37.7%), fatigue (36.5%) and diarrhoea (24.6%).
  • Most common grade ≥ 3 reactions: ALT increased (9.6%), AST increased (4.2%) and GGT increased (3.0%).
  • Serious: hepatic failure, autoimmune hepatitis and ALT increased (0.6% each).

Interactions

  • Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) increase vorasidenib levels; avoid.
  • Vorasidenib is a strong inducer (PXR activation) and may lower levels of other medicines.

Pregnancy and breastfeeding

  • Pregnancy test before starting; effective contraception for women and men during treatment and for at least 2 months after the last dose.
  • Pregnancy: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VoranigoLes Laboratoires Servier · EMEA/H/C/006284

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Voranigo
Liechtenstein
Voranigo
Norway
Voranigo

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Voranigo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.