Darolutamide (Nubeqa)

General information

Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Prostate cancer

Patient drug information

• Darolutamide (Nubeqa) package insert
• Darolutamide (Nubeqa) patient drug information (Chemocare)
• Darolutamide (Nubeqa) patient drug information (UpToDate)

History of changes in FDA indication

• 7/30/2019: Initial approval for non-metastatic castration-resistant prostate cancer. (Based on ARAMIS)
• 8/5/2022: FDA approved "in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC)." (Based on ARASENS)

Also known as

• Code name: BAY-1841788, ODM-201
• Brand name: Nubeqa