Difference between revisions of "Cabazitaxel (Jevtana)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization, inhibiting interphase/mitosis processes.<ref name="insert">[http://products.sanofi.us/jevtana/jevtana.pdf Cabazitaxel (Jevtana) package insert]</ref><ref>[[ | + | Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization, inhibiting interphase/mitosis processes.<ref name="insert">[http://products.sanofi.us/jevtana/jevtana.pdf Cabazitaxel (Jevtana) package insert]</ref><ref>[[:File:Cabazitaxel.pdf | Cabazitaxel (Jevtana) package insert (locally hosted backup)]]</ref><ref>[http://www.jevtana.com/ Jevtana manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | 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. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/refdrug-srch/jevtana-cabazitaxel-999571 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://products.sanofi.us/jevtana/jevtana.pdf Cabazitaxel (Jevtana) package insert]<ref name="insert"></ref> | *[http://products.sanofi.us/jevtana/jevtana.pdf Cabazitaxel (Jevtana) package insert]<ref name="insert"></ref> | ||
| − | *[ | + | *[https://chemocare.com/druginfo/cabazitaxel.aspx Cabazitaxel (Jevtana) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/cabazitaxel.aspx Cabazitaxel (Jevtana) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/cabazitaxel-patient-drug-information Cabazitaxel (Jevtana) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cabazitaxel-patient-drug-information Cabazitaxel (Jevtana) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/cabazitaxel-patient-drug-information Cabazitaxel (Jevtana) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cabazitaxel-patient-drug-information Cabazitaxel (Jevtana) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2010-06-17: Initial approval in combination with [[Prednisone (Sterapred) | prednisone]] for treatment of patients with hormone-refractory metastatic [[Prostate cancer | prostate cancer]] previously treated with a [[Regimen_classes#Docetaxel-containing_regimen| docetaxel-containing treatment regimen]]. ''(Based on TROPIC)'' |
| + | *2017-09-14: Approved at a lower dose (20 mg/m<sup>2</sup> every 3 weeks) in combination with [[Prednisone (Sterapred) | prednisone]] for the treatment of patients with metastatic castration-resistant [[prostate cancer]] previously treated with a [[Regimen_classes#Docetaxel-containing_regimen| docetaxel-containing treatment regimen]]. ''(Based on PROSELICA)'' | ||
| + | *2020-12-18: Approved in combination with prednisone for treatment of patients with metastatic castration-resistant [[prostate cancer]] previously treated with a [[Regimen_classes#Docetaxel-containing_regimen| docetaxel-containing treatment regimen]]. ''(Based on CARD)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2011-03-17: Initial marketing authorization as Jevtana. Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic [[prostate cancer]] previously treated with a docetaxel-containing regimen. ''(Based on TROPIC)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2011-06-06: Initial notice of compliance for the treatment of patients with castration resistant (hormone refractory) metastatic [[prostate cancer]] previously treated with a docetaxel containing regimen. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2014-07-04: Initial approval for the treatment of [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | + | *'''Code names:''' XRP-6258, TXD-258, RPR-116258A | |
| + | *'''Brand names:''' Cabapan, Cabaxan, Cabazither, Cabtana, Cazat, Jevatax, Jevtana, Kabanat, Procabazi, Qtervaxia, Z-Texel | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | + | [[Category:Intravenous medications]] | |
| − | [[Category:Intravenous | ||
[[Category:Taxanes]] | [[Category:Taxanes]] | ||
| Line 31: | Line 39: | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2011]] |
| + | [[Category:FDA approved in 2010]] | ||
| + | [[Category:Health Canada approved in 2011]] | ||
| + | [[Category:PMDA approved in 2014]] | ||
Revision as of 00:00, 10 September 2023
General information
Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization, inhibiting interphase/mitosis processes.[1][2][3]
Route: IV
Extravasation: no information
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
- Cabazitaxel (Jevtana) package insert[1]
- Cabazitaxel (Jevtana) patient drug information (Chemocare)[4]
- Cabazitaxel (Jevtana) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2010-06-17: Initial approval in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. (Based on TROPIC)
- 2017-09-14: Approved at a lower dose (20 mg/m2 every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. (Based on PROSELICA)
- 2020-12-18: Approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. (Based on CARD)
History of changes in EMA indication
- 2011-03-17: Initial marketing authorization as Jevtana. Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. (Based on TROPIC)
History of changes in Health Canada indication
- 2011-06-06: Initial notice of compliance for the treatment of patients with castration resistant (hormone refractory) metastatic prostate cancer previously treated with a docetaxel containing regimen.
History of changes in PMDA indication
- 2014-07-04: Initial approval for the treatment of prostate cancer.
Also known as
- Code names: XRP-6258, TXD-258, RPR-116258A
- Brand names: Cabapan, Cabaxan, Cabazither, Cabtana, Cazat, Jevatax, Jevtana, Kabanat, Procabazi, Qtervaxia, Z-Texel