Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Phesgo 600 mg/600 mg solution for injection.
Phesgo 1200 mg/600 mg solution for injection.
| Pharmaceutical Form |
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Solution for injection. Clear to opalescent solution, colourless to slightly brownish, pH 5.2-5.8, osmolality of 270-370 and 275-375 mOsmol/kg for the 1200 mg/600 mg and 600 mg/600 mg solutions, respectively. |
Phesgo 600 mg/600 mg solution for injection: One vial of 10 mL solution contains 600 mg of pertuzumab and 600 mg of trastuzumab. Each mL of solution contains 60 mg of pertuzumab and 60 mg of trastuzumab
Phesgo 1200 mg/600 mg solution for injection: One vial of 15 mL solution contains 1200 mg of pertuzumab and 600 mg of trastuzumab.
Pertuzumab and trastuzumab are humanised immunoglobulin (Ig)G1 monoclonal antibodies produced in mammalian (Chinese hamster ovary) cells by recombinant deoxyribonucleic acid (DNA) technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pertuzumab |
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). 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. |
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| Pertuzumab and Trastuzumab |
Pertuzumab and trastuzumab are recombinant humanised IgG1 monoclonal antibodies which target the human epidermal growth factor receptor 2 (HER2). Both substances bind to distinct HER2 subdomains without competing and have complementary mechanisms for disrupting HER2 signalling. Additionally, both substances mediate antibody-dependent cell-mediated cytotoxicity (ADCC). |
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| Trastuzumab |
Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). ฮคrastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. |
| List of Excipients |
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Vorhyaluronidase alfa |
Pack of one 15 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper, containing 10 mL solution of 600 mg of pertuzumab and 600 mg of trastuzumab. The stopper is sealed with aluminium and covered by an orange plastic flip-off cap.
Pack of one 20 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper, containing 15 mL solution of 1200 mg of pertuzumab and 600 mg of trastuzumab. The stopper is sealed with aluminum and covered by a cool green plastic flip-off cap.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/20/1497/001 (1200 mg/600 mg)
EU/1/20/1497/002 (600 mg/600 mg)
Date of first authorisation: 21 December 2020
| Drug | Countries | |
|---|---|---|
| PHESGO | Austria, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States, South Africa |
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