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Androgen Receptor Inhibitor (Specialist Oncology Drug)

Apalutamide

Brand names: Erleada

Adult dose

Dose: Refer to BNF, SmPC, and current SACT protocol
Route: Oral
Frequency: As per SACT/MDT guidance

Clinical pearls

  • Indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) with high-risk features (PSA doubling time ≤10 months), and for metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT
  • SPARTAN trial: apalutamide significantly improved MFS in nmCRPC
  • TITAN trial: apalutamide + ADT improved OS and rPFS in mCSPC
  • NICE TA585 (nmCRPC), TA740 (mCSPC): both recommended in England
  • Potent CYP inducer — major drug interaction issue: check interactions for all concomitant medications
  • Rash management: antihistamines, dose reduction; consider stopping if Grade 3–4

Contraindications

  • Women who are or may become pregnant (teratogenic)
  • Hypersensitivity to apalutamide or excipients
  • See SmPC

Side effects

  • Rash (very common — including severe cutaneous reactions such as DRESS and SJS)
  • Fatigue
  • Falls and fractures (androgen receptor inhibition reduces bone density)
  • Hypertension
  • Seizures (rare — androgen receptor inhibitor class effect)
  • Hypothyroidism
  • Ischaemic cardiovascular events

Interactions

  • Strong CYP3A4 inducer — apalutamide significantly reduces levels of many drugs: warfarin, hormonal contraceptives, direct-acting antivirals, statins, immunosuppressants
  • Review all concomitant medications on starting apalutamide
  • See SmPC for full interaction table

Monitoring

  • PSA monthly, then 3-monthly
  • DEXA scan (bone mineral density) at baseline and periodically
  • Thyroid function tests
  • Cardiovascular risk assessment
  • Skin reactions (CTCAE grading)
  • Seizure history

Reference: BNF; NICE TA585 (Apalutamide for non-metastatic castration-resistant prostate cancer, 2019); NICE TA740 (mCSPC, 2021); SPARTAN trial (NEJM 2018); TITAN trial (NEJM 2019); EAU Prostate Cancer Guidelines (2024); https://bnf.nice.org.uk/drugs/apalutamide/. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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