• TRADE NAMES: Nubeqa (Bayer); ODM-201 (Bayer)
  • INDICATIONS: Treatment of patients with non-metastatic castration-resistant prostate cancer. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
  • SYNONYM: Nubeqa
  • CLASS: Androgen receptor inhibitor
  • HALF-LIFE: 20 hours
  • FDA APPROVAL DATE: 07/30/2019
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    BCRP substrates, CYP3A inducers, CYP3A inhibitors
  • PREGNANCY: May cause fetal harm and loss of pregnancy when administered to a pregnant female. Males with female partners of reproductive potential are advised to use effective contraception during treatment and for 1 week after the last dose of darolutamide.

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Page last updated 07/31/2023

Symbol key

Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric