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darolutamide

Nubeqa · ATC code L02BB

Also known as: Darolutamid

Key facts
Active substance
darolutamide
ATC code
L02BB
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
NUBEQA 300 mg film-coated tablets
Marketing authorisation holder
Bayer AG
Information as of
2026-10-27

Key facts

Darolutamide is an androgen receptor inhibitor (Nubeqa). It is used in adult men with prostate cancer, in some settings combined with androgen deprivation therapy and docetaxel.

What it is used for

  • Non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of developing metastatic disease
  • Metastatic hormone-sensitive prostate cancer (mHSPC) with androgen deprivation therapy
  • mHSPC with docetaxel and androgen deprivation therapy

Dosing

  • 600 mg (two 300 mg tablets) twice daily, total daily dose 1,200 mg, swallowed whole with food
  • Continue until disease progression or unacceptable toxicity; continue medical castration (GnRH analogue) if not surgically castrated
  • mHSPC with docetaxel: first of 6 docetaxel cycles within 6 weeks after starting darolutamide
  • For ≥ Grade 3 toxicity: withhold or reduce to 300 mg twice daily; reduction below 300 mg twice daily is not recommended
  • Severe renal impairment not on haemodialysis, and moderate/severe hepatic impairment: starting dose 300 mg twice daily

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Women who are or may become pregnant

Important warnings

  • Severe renal or moderate/severe hepatic impairment: limited data, monitor closely for adverse reactions
  • Patients with clinically significant cardiovascular disease in the past 6 months were excluded from studies; safety not established
  • Permanently discontinue if liver tests suggest idiosyncratic drug-induced liver injury

Side effects

  • nmCRPC/mHSPC: most frequent fatigue/asthenic conditions (13.7%)
  • mHSPC with docetaxel: most frequent rash (16.6%) and hypertension (13.8%)
  • Others include ischaemic heart disease, heart failure, rash

Interactions

  • Strong and moderate CYP3A4 and P-gp inducers (e.g. carbamazepine, phenobarbital, St John's Wort, phenytoin, rifampicin) not recommended unless no alternative
  • Rifampicin decreased mean darolutamide exposure by 72%
  • Darolutamide is a substrate of CYP3A4, P-gp and BCRP; inhibitors may increase exposure

Pregnancy and breastfeeding

  • Not indicated in women of childbearing potential; may cause foetal harm
  • Men with a partner of childbearing potential: highly effective contraception during and for 1 week after treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet for patients →

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)

  • NubeqaBayer AG · EMEA/H/C/004790

Source: European Medicines Agency (EMA), product information

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

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

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Sources

  1. European Medicines Agency. Nubeqa – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.