Pertuzumab

Therapeutic Pertuzumab antibody from the original Perjeta® commercial drug.

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Product
Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
HER2
Monoclonal Antibody
Perjeta®
30 mg/mL
yes
6 mg
-80°C
11/2020
557,00 
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Perjeta® / Pertuzumab Reference Product

Drug namePerjeta®
INNPertuzumab
API typePertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster
ovary) cells by recombinant DNA technology.
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC13
Target of antibody
HER2
General functionPertuzumab is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4. As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K). Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively. In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
Original license holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Marketing authorisation numbers
EU/1/13/813/001
Marketing authorisation holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Name of the manufacturer of the biological active substance
Genentech, Inc.
1000 New Horizons Way
Vacaville, CA 95688-9431
USA
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Whylen
Germany
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
Glacial acetic acid
L-Histidine
Sucrose
Polysorbate 20
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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