Difference between revisions of "Ziv-aflibercept (Zaltrap)"

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'''FDA approved 8/3/2012'''.  Also known as aflibercept or VEGF trap.  When used for macular degeneration, it is known as Eylea. 
 
 
 
==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 PLGF (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">[http://www.regeneron.com/zaltrap/zaltrap-fpi.pdf Ziv-aflibercept (Zaltrap) package insert]</ref><ref>[[Media:Zivaflibercept.pdf|Ziv-aflibercept (Zaltrap) package insert (locally hosted backup)]]</ref><ref>[http://www.regeneron.com/zaltrap/ Zaltrap manufacturer's website]</ref>
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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. 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>
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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>
  
==Clinical trials==
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==Diseases for which it is used==
*[http://new.ecco-org.eu/ecco_content/2011StockholmLateBreakingflipbook/files/assets/seo/page9.html VELOUR, a Phase 3 Study of Aflibercept (A) Versus Placebo (pbo) in Combination with FOLFIRI for the Treatment of Patients (pt) with Previously Treated Metastatic Colorectal Cancer (MCRC)]<ref>J. Tabernero, E. Van Cutsem, R. Lakomy, J. Prausova, P. Ruff, G. Van Hazel, V. Moiseyenko, D. Ferry, J. McKendrick, K. Soussan-Lazard, E. Boelle, C. Allegra. [http://new.ecco-org.eu/ecco_content/2011StockholmLateBreakingflipbook/files/assets/seo/page9.html VELOUR, a Phase 3 Study of Aflibercept (A) Versus Placebo (pbo) in Combination with FOLFIRI for the Treatment of Patients (pt) with Previously Treated Metastatic Colorectal Cancer (MCRC)]. [http://stockholm2011.ecco-org.eu/Programme.aspx 2011 European Multidisciplinary Congress]. Abstract 6LBA. Presented September 25, 2011.</ref>
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*[[Colorectal cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
*Brief patient counseling information is available on [http://www.regeneron.com/zaltrap/zaltrap-fpi.pdf#page=17 pages 16-17 of the package insert].<ref name="insert"></ref>
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*[https://products.sanofi.us/Zaltrap/Zaltrap.html Ziv-aflibercept (Zaltrap) package insert].<ref name="insert"></ref>
*[http://www.uptodate.com/contents/aflibercept-patient-drug-information Aflibercept patient drug information (UpToDate)] -- note: this is for Eylea, not Zaltrap<ref>[http://www.uptodate.com/contents/aflibercept-patient-drug-information Aflibercept patient drug information (UpToDate)]</ref>
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*[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>
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*[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>
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==History of changes in FDA indication==
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* 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)''
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==History of changes in EMA indication==
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*2013-02-01: Initial marketing authorization as Zaltrap.
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==History of changes in Health Canada indication==
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*2014-02-12: Initial notice of compliance
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==History of changes in PMDA indication==
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*2017-03-30: Initial approval for the treatment of unresectable advanced or recurrent [[colorectal cancer]].
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==Also known as==
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*'''Generic names:''' aflibercept, aflibercept beta, VEGF trap, ziv-aflibercept
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*'''Brand names:''' Zaltrap
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Intravenous medications]]
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[[Category:VEGFR inhibitors]]
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[[Category:Soluble decoy receptors]]
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[[Category:Colorectal cancer medications]]
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[[Category:EMA approved in 2013]]
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[[Category:FDA approved in 2012]]
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[[Category:Health Canada approved in 2014]]
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[[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

History of changes in FDA indication

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

References