Darolutamide: Uses, Interactions and Safety
Uses
Darolutamide blocks androgen receptor signalling in selected prostate cancers. The EU label includes high-risk non-metastatic castration-resistant disease and metastatic hormone-sensitive disease with androgen deprivation, with or without docetaxel according to the regimen. Turkish Nubeqa eligibility includes additional disease-volume and visceral-metastasis conditions, so treatment selection follows the local label.
Administration
Film-coated tablets are swallowed whole with food. The prescribed regimen and accompanying androgen deprivation should be followed consistently. Docetaxel, where indicated, has separate administration and safety requirements. Kidney or liver impairment can alter exposure and requires specialist assessment; patients should not adjust their own tablets.
Safety
Liver injury, ischaemic heart disease and heart failure are important considerations. Report jaundice, dark urine, chest pain, worsening swelling or breathlessness promptly. People with significant recent cardiovascular disease were not well represented in the pivotal studies. Liver and kidney function help the team judge treatment suitability and monitoring.
Interactions
Darolutamide inhibits BCRP and OATP transporters and can markedly increase rosuvastatin exposure. The label recommends avoiding that combination when an alternative exists. Other affected medicines include methotrexate, sulfasalazine and certain statins. Strong or moderate CYP3A inducers can reduce darolutamide exposure. Combined strong CYP3A and P-gp inhibitors may increase adverse effects and require closer monitoring. Darolutamide is only a mild CYP3A inducer; it should not inherit the extensive strong-inducer warnings of enzalutamide or apalutamide.
Pregnancy and breastfeeding
Darolutamide is not indicated for women and is contraindicated in women who are or could become pregnant. Male patients should discuss effective partner protection during treatment and for one week afterwards. Excretion into human milk is unknown.
Adverse effects
Fatigue is common. Blood tests may show changes in liver enzymes, bilirubin or neutrophils. Rash and hypertension are prominent in the docetaxel combination; the accompanying medicines contribute their own risks.
Sources
Additional verified references
The linked Turkish profile contains the medicine record and its documented interaction list.