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Androgen Receptor Inhibitor Pregnancy: X

Enzalutamide

Brand names: Xtandi

Adult dose

Dose: 160 mg once daily
Route: oral
Frequency: once daily
Max: 160 mg/day
Take with or without food; seizure risk — use with caution in patients with risk factors; strong CYP inducer — many drug interactions

Paediatric dose

Route:
Not licensed in children

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment in mild-moderate impairment; caution in severe impairment

Clinical pearls

  • AFFIRM trial: 4.8 month survival benefit in mCRPC post-docetaxel
  • PREVAIL/PROSPER trials: extended use to non-metastatic and castration-sensitive disease
  • Seizure risk 0.5% — review all concomitant medications for threshold-lowering drugs

Contraindications

  • Women of childbearing potential
  • Seizure disorder (relative CI)
  • Concomitant strong CYP3A4 inhibitors without dose adjustment

Side effects

  • Fatigue
  • Hot flushes
  • Hypertension
  • Seizures (0.5%)
  • Falls
  • Cognitive impairment
  • Neutropaenia

Interactions

  • Strong CYP3A4/2C9/2C19 inducer — reduces warfarin, statins, anticonvulsants; avoid concomitant midazolam

Monitoring

  • Seizure risk assessment
  • BP
  • FBC
  • Drug interactions review

Reference: BNFc; BNF 86; NICE TA580; AFFIRM trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.