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belzutifan

Welireg · ATC code L01XX74

Key facts
Active substance
belzutifan
ATC code
L01XX74
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
WELIREG 40 mg film-coated tablets
Marketing authorisation holder
Merck Sharp & Dohme B.V.
Information as of
2026-10-28

Key facts

Belzutifan (Welireg) is an oral anticancer medicine (a hypoxia-inducible factor 2α inhibitor) used for advanced clear cell renal cell carcinoma and von Hippel-Lindau disease-associated tumours.

What it is used for

  • Monotherapy for adults with advanced clear cell renal cell carcinoma that progressed after two or more lines of therapy including a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
  • Monotherapy for adults with von Hippel-Lindau disease who require therapy for associated localised renal cell carcinoma, CNS haemangioblastomas or pancreatic neuroendocrine tumours, and for whom localised procedures are unsuitable.

Dosing

  • 120 mg (three 40 mg tablets) once daily at the same time each day, until disease progression or unacceptable toxicity.
  • For Grade 3 or 4 anaemia, hypoxia or other adverse reactions: withhold and resume at a dose reduced by 40 mg, or discontinue; Grade 4 hypoxia: permanently discontinue.
  • No dose adjustment in the elderly, renal impairment (including end-stage renal disease) or mild or moderate hepatic impairment; not studied in severe hepatic impairment.
  • A missed dose can be taken the same day; do not take another dose after vomiting.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Pregnancy in patients with VHL disease-associated tumours.

Important warnings

  • Anaemia: monitor before and periodically during treatment; withhold for Grade 3 and treat according to standard practice, including erythropoiesis-stimulating agents.
  • Hypoxia has been reported; withhold, reduce the dose or discontinue depending on severity.
  • May cause embryo-foetal harm; verify pregnancy status before starting.
  • May cause hormonal contraceptive failure.

Side effects

  • Most common: anaemia (84.2%), fatigue (42.7%), nausea (24.1%), dyspnoea (21.4%), dizziness (17.9%) and hypoxia (16.3%).
  • Most common Grade 3 or 4 reactions: anaemia (28.8%) and hypoxia (12.2%).
  • Most common serious reactions: hypoxia (7.1%), anaemia (4.7%) and dyspnoea (1.2%).

Interactions

  • Belzutifan induces CYP3A4 and lowers concentrations of CYP3A4 substrates; avoid sensitive CYP3A4 substrates or increase their dose.
  • Hormonal contraceptives may fail; use a non-hormonal method or a male partner condom.
  • Metabolised by UGT2B17 and CYP2C19.

Pregnancy and breastfeeding

  • Women of childbearing potential must use highly effective contraception during treatment and for at least 1 week after the last dose.
  • Contraindicated in pregnancy for VHL disease-associated tumours; do not breast-feed during treatment and for at least 1 week after the last dose.

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)

  • WeliregMerck Sharp & Dohme B.V. · EMEA/H/C/005636

Source: European Medicines Agency (EMA), product information

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

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.

Other substances in the same group

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Sources

  1. European Medicines Agency. Welireg – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/welireg-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.