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Second-generation androgen receptor antagonist

Darolutamide

Brand names: Nubeqa

Adult dose

Dose: 600mg BD with food
Route: Oral
Frequency: BD

Clinical pearls

  • NICE TA660 / TA805: nmCRPC and mHSPC (with ADT ± docetaxel)
  • ESMO prostate cancer; NICE NG131
  • Lower BBB penetration → fewer CNS effects vs alternatives

Contraindications

  • Pregnancy (no female indication)
  • Severe hepatic impairment
  • Hypersensitivity

Side effects

  • Fatigue
  • Falls
  • Fractures
  • Ischaemic heart disease
  • Hyperglycaemia
  • Increased bilirubin/AST/ALT
  • Less CNS toxicity (seizures/mood) than enzalutamide / apalutamide

Interactions

  • Strong CYP3A4 inducers
  • BCRP inhibitors
  • Statins (rosuvastatin levels increased)

Monitoring

  • LFTs
  • BP
  • Bone health
  • CV risk factors

Reference: BNF; NICE TA660; NICE TA805; NICE NG131; ESMO; SmPC; https://bnf.nice.org.uk/drugs/darolutamide/. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.