Darolutamide

How it works

It binds the androgen receptor and inhibits its nuclear translocation and downstream transcriptional activity, suppressing androgen-driven prostate tumour growth.

Prescribing in practice

• It must be combined with ongoing androgen deprivation therapy (or bilateral orchidectomy) and is not a substitute for it.
• Fatigue, rashes and changes in some blood parameters may occur, and it can interact with breast cancer resistance protein and CYP3A4 substrates.
• Women who are or may become pregnant should not handle the tablets without protection given the potential to affect a developing fetus.

Monitoring

Monitor prostate-specific antigen and clinical response, together with tolerability and relevant drug interactions during treatment.

Counselling the patient

• Continue your hormone injections or implants as well as taking these tablets.
• Take the tablets with food as directed and report troublesome fatigue or rash.
• Tell your team about all other medicines because interactions are possible.

Evidence & guidelines

The ARAMIS trial showed darolutamide prolonged metastasis-free survival in non-metastatic castration-resistant prostate cancer, and ARASENS supported its use in metastatic hormone-sensitive disease.