Difference between revisions of "Abiraterone (Zytiga)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Antiandrogen, androgen biosynthesis inhibitor, CYP17 inhibitor. | + | 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.<ref name="insert">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf Abiraterone (Zytiga) package insert]</ref><ref>[[:File:Abiraterone.pdf | Abiraterone (Zytiga) package insert (locally hosted backup)]]</ref><ref>[https://www.zytiga.com/ Zytiga manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf Abiraterone (Zytiga) package insert]<ref name="insert"></ref> | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf Abiraterone (Zytiga) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/abiraterone-acetate.aspx Abiraterone (Zytiga) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/abiraterone-acetate.aspx Abiraterone (Zytiga) patient drug information (Chemocare)]</ref> |
*[https://www.janssencarepath.com/hcp/zytiga Janssen CarePath patient support resources]<ref>[https://www.janssencarepath.com/hcp/zytiga Janssen CarePath patient support resources]</ref> | *[https://www.janssencarepath.com/hcp/zytiga Janssen CarePath patient support resources]<ref>[https://www.janssencarepath.com/hcp/zytiga Janssen CarePath patient support resources]</ref> | ||
*[http://www.uptodate.com/contents/abiraterone-patient-drug-information Abiraterone (Zytiga) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/abiraterone-patient-drug-information Abiraterone (Zytiga) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/abiraterone-patient-drug-information Abiraterone (Zytiga) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/abiraterone-patient-drug-information Abiraterone (Zytiga) patient drug information (UpToDate)]</ref> | ||
==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. Zytiga is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant [[prostate cancer]] in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. ''(Based on COU-AA-301)'' |
| − | + | *2012-12-18: Extension of Indication to include new population for Zytiga in combination with prednisone or prednisolone for the treatment of metastatic castration resistant [[prostate cancer]] in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. | |
| + | *2017-11-15: Extension of Indication to include treatment of newly diagnosed high risk metastatic hormone sensitive [[prostate cancer]] (mHSCP) in adult men in combination with androgen deprivation therapy (ADT) for Zytiga plus prednisone or prednisolone. | ||
| + | ==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. | ||
| + | *2013-05-28: New indication in combination with prednisone for the treatment of metastatic castration resistant [[prostate cancer]] (mCRPC) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT). | ||
| + | *2018-02-13: New 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. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2014-07-04: Initial approval for the treatment of castration-resistant [[prostate cancer]]. | ||
| + | *2018-02-16: New additional indication for the treatment of [[prostate cancer]] in patients with high-risk prognostic factors who have not received previous endocrine therapy. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' CB-7630 |
*'''Generic name:''' abiraterone acetate | *'''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 | *'''Brand name:''' Abatitor, Abione, Abiracine, Abiracure, Abirakast, Abiramab, Abirapro, Abirataj, Abiratas, Arbitus, Ariteron, Birato, MyTera, Samtica, Xbira, Yonsa, Zabiteron, Zecyte, Zelgor, Zybuca, Zytiga, Zytix | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | [[Category: | + | [[Category:CYP17 inhibitors]] |
| − | |||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| Line 41: | Line 48: | ||
[[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:PMDA approved in 2014]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Latest revision as of 21:16, 15 September 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. Zytiga is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. (Based on COU-AA-301)
- 2012-12-18: Extension of Indication to include new population for Zytiga in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
- 2017-11-15: Extension of Indication to include treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSCP) in adult men in combination with androgen deprivation therapy (ADT) for Zytiga plus prednisone or prednisolone.
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.
- 2013-05-28: New indication in combination with prednisone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).
- 2018-02-13: New 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.
History of changes in PMDA indication
- 2014-07-04: Initial approval for the treatment of castration-resistant prostate cancer.
- 2018-02-16: New additional indication for the treatment of prostate cancer in patients with high-risk prognostic factors who have not received previous endocrine therapy.
Also known as
- Code name: CB-7630
- 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)