Difference between revisions of "Abiraterone (Zytiga)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2011-04-28: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm FDA approved] to treat patients with late-stage (metastatic) castration-resistant [[Prostate cancer | prostate cancer]] who have received prior [[Docetaxel (Taxotere) | docetaxel]] (chemotherapy). ''(Based on COU-AA-301)'' |
| − | *12 | + | *2012-12-10: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm331492.htm FDA approved] to treat men with late-stage (metastatic) castration-resistant [[Prostate cancer | prostate cancer]] prior to receiving chemotherapy. ''(Based on COU-AA-302)'' |
| − | * | + | *2018-02-07: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abiraterone-acetate-combination-prednisone-high-risk-metastatic-castration-sensitive FDA approved] in combination with [[Prednisone (Sterapred)|prednisone]] for metastatic high-risk castration-sensitive [[prostate cancer]] (CSPC). ''(Based on LATITUDE)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2011-09-05: Initial marketing authorization as Zytiga. |
| − | + | ==History of changes in Health Canada indication== | |
| + | *2011-07-27: Initial notice of compliance with prednisone for the treatment of metastatic [[prostate cancer]] (castration-resistant prostate cancer) in patients who have received prior chemotherapy containing docetaxel. | ||
| + | *2018-02-13: Supplemental indication in combination with prednisone and androgen depletion therapy (ADT) for the treatment of patients with newly diagnosed high-risk metastatic [[prostate cancer]], who may have received up to 3 months of prior ADT. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CB7630 | *'''Code name:''' CB7630 | ||
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[[Category:EMA approved in 2011]] | [[Category:EMA approved in 2011]] | ||
[[Category:FDA approved in 2011]] | [[Category:FDA approved in 2011]] | ||
| + | [[Category:Health Canada approved in 2011]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 23:48, 1 April 2023
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.[1][2][3]
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.[1]
Diseases for which it is used
Patient drug information
- Abiraterone (Zytiga) package insert[1]
- Abiraterone (Zytiga) patient drug information (Chemocare)[4]
- Janssen CarePath patient support resources[5]
- Abiraterone (Zytiga) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2011-04-28: FDA approved to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). (Based on COU-AA-301)
- 2012-12-10: FDA approved to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy. (Based on COU-AA-302)
- 2018-02-07: FDA approved in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). (Based on LATITUDE)
History of changes in EMA indication
- 2011-09-05: Initial marketing authorization as Zytiga.
History of changes in Health Canada indication
- 2011-07-27: Initial notice of compliance with prednisone for the treatment of metastatic prostate cancer (castration-resistant prostate cancer) in patients who have received prior chemotherapy containing docetaxel.
- 2018-02-13: Supplemental indication in combination with prednisone and androgen depletion therapy (ADT) for the treatment of patients with newly diagnosed high-risk metastatic prostate cancer, who may have received up to 3 months of prior ADT.
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
References
- ↑ 1.0 1.1 1.2 Abiraterone (Zytiga) package insert
- ↑ Abiraterone (Zytiga) package insert (locally hosted backup)
- ↑ Zytiga manufacturer's website
- ↑ Abiraterone (Zytiga) patient drug information (Chemocare)
- ↑ Janssen CarePath patient support resources
- ↑ Abiraterone (Zytiga) patient drug information (UpToDate)