Difference between revisions of "Pertuzumab (Perjeta)"
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| − | '''FDA approved 6/8/2012.''' | + | '''FDA approved 6/8/2012.''' |
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==General information== | ==General information== | ||
Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).<ref name="insert">[http://www.gene.com/gene/products/information/perjeta/pdf/perjeta_prescribing.pdf Pertuzumab (Perjeta) package insert]</ref><ref>[[Media:Pertuzumab.pdf | Pertuzumab (Perjeta) package insert (locally hosted backup)]]</ref><ref>[http://www.perjeta.com/ Perjeta manufacturer's website]</ref> | Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).<ref name="insert">[http://www.gene.com/gene/products/information/perjeta/pdf/perjeta_prescribing.pdf Pertuzumab (Perjeta) package insert]</ref><ref>[[Media:Pertuzumab.pdf | Pertuzumab (Perjeta) package insert (locally hosted backup)]]</ref><ref>[http://www.perjeta.com/ Perjeta manufacturer's website]</ref> | ||
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<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 package insert. | + | 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 package insert.<ref name="insert"></ref> |
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| + | ==Diseases for which it is used== | ||
| + | *[[Breast cancer]] | ||
==Clinical trials== | ==Clinical trials== | ||
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==Patient drug information== | ==Patient drug information== | ||
| + | *[http://chemocare.com/chemotherapy/drug-info/Pertuzumab.aspx Pertuzumab (Perjeta) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/Pertuzumab.aspx Pertuzumab (Perjeta) patient drug information (Chemocare)]</ref> | ||
*[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]<ref>[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]</ref> | *[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]<ref>[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]</ref> | ||
| + | *Brief patient counseling information can be found on [http://www.gene.com/gene/products/information/perjeta/pdf/perjeta_prescribing.pdf#page=16 page 16 of the package insert]<ref name="insert"></ref> | ||
| + | *[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]</ref> | ||
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| + | ==History of changes in FDA indication== | ||
| + | *6/8/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm307592.htm FDA approved] "for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease." | ||
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| + | ==Also known as== | ||
| + | 2C4, Omnitarg, Rhumab 2C4. | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drug index]] | ||
| + | [[Category:Chemotherapy]] | ||
| + | [[Category:Antibody medications]] | ||
| + | [[Category:Anti-HER2 medications]] | ||
| + | [[Category:Breast cancer medications]] | ||
| + | [[Category:Drugs FDA approved in 2012]] | ||
Revision as of 15:29, 17 May 2013
FDA approved 6/8/2012.
General information
Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).[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, UpToDate (courtesy of Lexicomp), or the package insert.[1]
Diseases for which it is used
Clinical trials
Patient drug information
- Pertuzumab (Perjeta) patient drug information (Chemocare)[6]
- Pertuzumab (Perjeta) patient drug information[7]
- Brief patient counseling information can be found on page 16 of the package insert[1]
- Pertuzumab (Perjeta) patient drug information (UpToDate)[8]
History of changes in FDA indication
- 6/8/2012: FDA approved "for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease."
Also known as
2C4, Omnitarg, Rhumab 2C4.
References
- ↑ 1.0 1.1 1.2 Pertuzumab (Perjeta) package insert
- ↑ Pertuzumab (Perjeta) package insert (locally hosted backup)
- ↑ Perjeta manufacturer's website
- ↑ Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. Epub 2011 Dec 7. link to original article PubMed
- ↑ Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. Epub 2011 Dec 6. link to original article PubMed
- ↑ Pertuzumab (Perjeta) patient drug information (Chemocare)
- ↑ Pertuzumab (Perjeta) patient drug information
- ↑ Pertuzumab (Perjeta) patient drug information (UpToDate)