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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.
Excipient with known effect: One mL of solution contains 0.6 mg of polysorbate 80.
Excipients/Inactive Ingredients: Ethylenediaminetetraacetic acid (EDTA) disodium salt dihydrate, L-Histidine, L-Histidine hydrochloride monohydrate, L-Methionine, Polysorbate 80, Sucrose, Water for injections.
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