Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Rybrevant 350 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. The solution is colourless to pale yellow, with a pH of 5.7 and an osmolality of approximately 310 mOsm/kg. |
One mL of concentrate for solution for infusion contains 50 mg amivantamab. One 7 mL vial contains 350 mg of amivantamab.
Amivantamab is a fully-human Immunoglobulin G1 (IgG1)-based bispecific antibody directed against the epidermal growth factor (EGF) and mesenchymal-epidermal transition (MET) receptors, produced by a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amivantamab |
Amivantamab is a low-fucose, fully-human IgG1-based EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating EGFR Exon 20 insertion mutations. Amivantamab binds to the extracellular domains of EGFR and MET. Amivantamab disrupts EGFR and MET signalling functions through blocking ligand binding and enhancing degradation of EGFR and MET, thereby preventing tumour growth and progression. |
| List of Excipients |
|---|
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Ethylenediaminetetraacetic acid (EDTA) disodium salt dihydrate |
7 mL concentrate in a Type 1 glass vial with an elastomeric closure and aluminium seal with a flip-off cap containing 350 mg amivantamab. Pack size of 1 vial.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Date of first authorisation: 09 December 2021
Date of latest renewal: 11 September 2023
| Drug | Countries | |
|---|---|---|
| RYBREVANT | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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