FDA label
What is Nubeqa used for?
Nubeqa contains darolutamide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC); metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.”
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Nubeqa, tablet, film coated
Indications and Usage, quoted from the label by Bayer HealthCare Pharmaceuticals Inc. (NDA212099). Cross-references to other label sections are left out.
NUBEQA is indicated for the treatment of adult patients with:
- non-metastatic castration resistant prostate cancer (nmCRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Source: DailyMed label, set id 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e, version 24, effective September 28, 2026. NDC 50419-395, one of 1 listing for this product.
Questions
What is Nubeqa used for?
The FDA label says: “NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC); metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.”
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.