Difference between revisions of "Trabectedin (Yondelis)"
Jump to navigation
Jump to search
m |
Warner-admin (talk | contribs) m (Text replacement - "[http://online.lexi.com/ Lexicomp]" to "Lexicomp") |
||
| (4 intermediate revisions by 2 users not shown) | |||
| Line 4: | Line 4: | ||
<br>Extravasation: [[vesicant]] | <br>Extravasation: [[vesicant]] | ||
| − | 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 | + | 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, [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 15: | Line 15: | ||
*[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/YONDELIS-pi.pdf Trabectedin (Yondelis) package insert]<ref name="insert"></ref> | *[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/YONDELIS-pi.pdf Trabectedin (Yondelis) package insert]<ref name="insert"></ref> | ||
*[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]<ref>[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]</ref> | *[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]<ref>[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]</ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]</ref> | ||
| Line 22: | Line 22: | ||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2007-09-17: Initial authorization | *2007-09-17: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2010-05-13: Initial notice of compliance | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2015-09-28: Initial approval for the treatment of patients with [[soft tissue sarcoma]]. | *2015-09-28: Initial approval for the treatment of patients with [[soft tissue sarcoma]]. | ||
| Line 35: | Line 37: | ||
[[Category:Vesicant]] | [[Category:Vesicant]] | ||
[[Category:Alkylating agents]] | [[Category:Alkylating agents]] | ||
| − | |||
| − | |||
[[Category:Leiomyosarcoma medications]] | [[Category:Leiomyosarcoma medications]] | ||
| Line 45: | Line 45: | ||
[[Category:EMA approved in 2007]] | [[Category:EMA approved in 2007]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:Health Canada approved in 2010]] | ||
[[Category:PMDA approved in 2015]] | [[Category:PMDA approved in 2015]] | ||
Latest revision as of 12:11, 29 June 2024
General information
Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix and its major groove. This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.[1][2][3]
Route: IV
Extravasation: vesicant
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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Trabectedin (Yondelis) package insert[1]
- Trabectedin (Yondelis) patient drug information from manufacturer[4]
- Trabectedin (Yondelis) patient drug information (Chemocare)[5]
- Trabectedin (Yondelis) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2015-10-23: Approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. (Based on ET743-SAR-3007)
History of changes in EMA indication
- 2007-09-17: Initial authorization
History of changes in Health Canada indication
- 2010-05-13: Initial notice of compliance
History of changes in PMDA indication
- 2015-09-28: Initial approval for the treatment of patients with soft tissue sarcoma.
Also known as
- Code name: ET-743
- Brand name: Yondelis
References
- ↑ 1.0 1.1 1.2 Trabectedin (Yondelis) package insert
- ↑ Trabectedin (Yondelis) package insert (locally hosted backup)
- ↑ Yondelis manufacturer's website
- ↑ Trabectedin (Yondelis) patient drug information from manufacturer
- ↑ Trabectedin (Yondelis) patient drug information (Chemocare)
- ↑ Trabectedin (Yondelis) patient drug information (UpToDate)