Difference between revisions of "Ziv-aflibercept (Zaltrap)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Recombinant fusion protein between the Fc portion of human IgG1 and the extracellular domains of VEGF receptor 1 & 2 (VEGFR 1 & VEGFR 2), which binds VEGF-A and VEGF-B (vascular endothelial growth factor), as well as PGF (placental growth factor). By binding to and inhibiting these angiogenic growth factors, their neovascular activity, and vascular permeability, ziv-aflibercept inhibits tumor angiogenesis.<ref name="insert">[ | + | Class/mechanism: Recombinant fusion protein between the Fc portion of human IgG1 and the extracellular domains of VEGF receptor 1 & 2 (VEGFR 1 & VEGFR 2), which binds VEGF-A and VEGF-B (vascular endothelial growth factor), as well as PGF (placental growth factor). By binding to and inhibiting these angiogenic growth factors, their neovascular activity, and vascular permeability, ziv-aflibercept inhibits tumor angiogenesis.<ref name="insert">[https://products.sanofi.us/Zaltrap/Zaltrap.html Ziv-aflibercept (Zaltrap) package insert]</ref><ref>[[:File:Zivaflibercept.pdf|Ziv-aflibercept (Zaltrap) package insert (locally hosted backup)]]</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://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== | ||
| − | *[[ | + | *[[Colorectal cancer]] |
| − | |||
| − | |||
| − | |||
| − | |||
==Patient drug information== | ==Patient drug information== | ||
| − | * | + | *[https://products.sanofi.us/Zaltrap/Zaltrap.html Ziv-aflibercept (Zaltrap) package insert].<ref name="insert"></ref> |
| + | *[https://chemocare.com/druginfo/ziv-aflibercept.aspx Ziv-aflibercept (Zaltrap) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ziv-aflibercept.aspx Ziv-aflibercept (Zaltrap) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/aflibercept-ziv-aflibercept-systemic-drug-information Ziv-aflibercept (Zaltrap) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/aflibercept-ziv-aflibercept-systemic-drug-information Ziv-aflibercept (Zaltrap) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/aflibercept-ziv-aflibercept-systemic-drug-information Ziv-aflibercept (Zaltrap) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/aflibercept-ziv-aflibercept-systemic-drug-information Ziv-aflibercept (Zaltrap) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2012-08-31: Initial FDA approval in combination with [[Fluorouracil (5-FU) | 5-fluorouracil]], [[Leucovorin (Folinic acid) | leucovorin]], [[Irinotecan (Camptosar) | irinotecan]] - ([[Colorectal_cancer#FOLFIRI_.26_Ziv-aflibercept| FOLFIRI]]), is indicated for patients with metastatic [[colorectal cancer]] (mCRC) that is resistant to or has progressed following an [[Regimen_classes#Oxaliplatin-based_regimen | oxaliplatin-containing regimen]]. ''(Based on VELOUR)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2013-02-01: Initial marketing authorization as Zaltrap. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2014-02-12: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-03-30: Initial approval for the treatment of unresectable advanced or recurrent [[colorectal cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Generic names:''' aflibercept, VEGF trap | + | *'''Generic names:''' aflibercept, aflibercept beta, VEGF trap, ziv-aflibercept |
| − | *'''Brand names:''' | + | *'''Brand names:''' Zaltrap |
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category: | + | [[Category:VEGFR inhibitors]] |
| − | [[Category: | + | [[Category:Soluble decoy receptors]] |
| − | |||
| − | [[Category: | + | [[Category:Colorectal cancer medications]] |
| − | |||
| − | [[Category: | + | [[Category:EMA approved in 2013]] |
| + | [[Category:FDA approved in 2012]] | ||
| + | [[Category:Health Canada approved in 2014]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Revision as of 23:47, 7 November 2023
General information
Class/mechanism: Recombinant fusion protein between the Fc portion of human IgG1 and the extracellular domains of VEGF receptor 1 & 2 (VEGFR 1 & VEGFR 2), which binds VEGF-A and VEGF-B (vascular endothelial growth factor), as well as PGF (placental growth factor). By binding to and inhibiting these angiogenic growth factors, their neovascular activity, and vascular permeability, ziv-aflibercept inhibits tumor angiogenesis.[1][2]
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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Ziv-aflibercept (Zaltrap) package insert.[1]
- Ziv-aflibercept (Zaltrap) patient drug information (Chemocare)[3]
- Ziv-aflibercept (Zaltrap) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2012-08-31: Initial FDA approval in combination with 5-fluorouracil, leucovorin, irinotecan - ( FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. (Based on VELOUR)
History of changes in EMA indication
- 2013-02-01: Initial marketing authorization as Zaltrap.
History of changes in Health Canada indication
- 2014-02-12: Initial notice of compliance
History of changes in PMDA indication
- 2017-03-30: Initial approval for the treatment of unresectable advanced or recurrent colorectal cancer.
Also known as
- Generic names: aflibercept, aflibercept beta, VEGF trap, ziv-aflibercept
- Brand names: Zaltrap