Abiraterone (Zytiga)

General information

Class/mechanism: Antiandrogen, androgen biosynthesis inhibitor, CYP17 inhibitor. Inhibits the 17 α-hydroxylase/C17,20-lyase (CYP17) enzyme that is required for androgen biosynthesis, leading to a decrease in androgen production in testicular, adrenal, and prostate tumor tissues.
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

• Abiraterone (Zytiga) package insert
• Abiraterone (Zytiga) patient drug information (Chemocare)
• Janssen CarePath patient support resources
• Abiraterone (Zytiga) patient drug information (UpToDate)

History of changes in FDA indication

• 4/28/2011: FDA approved to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). (Based on COU-AA-301)
• 12/10/2012: FDA approved to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy. (Based on COU-AA-302)
• 2/7/2018: FDA approved in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). (Based on LATITUDE)

History of changes in EMA indication

• 9/5/2011: Initial marketing authorization as Zytiga.

Also known as

• Code name: CB7630
• Generic name: abiraterone acetate
• Brand name: Abatitor, Abione, Abiracine, Abiracure, Abirakast, Abiramab, Abirapro, Abirataj, Abiratas, Arbitus, Ariteron, Birato, MyTera, Samtica, Xbira, Yonsa, Zabiteron, Zecyte, Zelgor, Zybuca, Zytiga, Zytix