Darolutamide
Brand names: Nubeqa
Darolutamide is an oral second-generation androgen-receptor inhibitor used in prostate cancer, including non-metastatic castration-resistant disease and, with chemotherapy, metastatic hormone-sensitive disease. It is always combined with ongoing androgen-deprivation therapy.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
It binds the androgen receptor with high affinity and blocks its nuclear translocation and signalling, suppressing androgen-driven prostate cancer growth.
Prescribing in practice
- Fatigue, fractures, and ischaemic cardiovascular events are recognised risks, so cardiovascular risk factors and bone health should be assessed and managed.
- Continue concurrent GnRH analogue therapy (or maintain surgical castration) throughout treatment.
- It has clinically relevant interactions via transporters and CYP3A4, so review co-medications against the SPC.
Monitoring
Monitor PSA and clinical response, and review for cardiovascular events, fractures, and significant fatigue during therapy.
Counselling the patient
- Take the tablets with food as directed.
- Report chest pain, breathlessness, or new bone pain promptly.
- Do not stop your other prostate (hormone) injections without advice.
Evidence & guidelines
Supported by randomised trials showing improved metastasis-free and overall survival in castration-resistant and hormone-sensitive prostate cancer.
Reference: NICE TA660 (Darolutamide for nmCRPC); ARAMIS Trial; ARASENS Trial; EAU Guidelines 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.