Nubeqa FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 31, 2022.
FDA Approved: Yes (First approved July 30, 2019)
Brand name: Nubeqa
Generic name: darolutamide
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer
Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) used in the treatment of prostate cancer.
- Nubeqa is indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC).
- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
- Nubeqa tablets are administered orally, twice a day.
- Warnings and precautions associated with Nubeqa include ischemic heart disease, seizures, and embryo-fetal toxicity.
- Common adverse reactions in nmCRPC include fatigue, pain in extremities, and rash. Common laboratory test abnormalities include increased AST, decreased neutrophil count, and increased bilirubin.
Common adverse reactions in mHSPC include constipation, decreased appetite, rash, hemorrhage, weight increase, and hypertension. Common laboratory test abnormalities include anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.
Development timeline for Nubeqa
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
