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White to yellowish-white lyophilised powder.
One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab deruxtecan. After reconstitution, one vial of 5 mL solution contains 20 mg/mL of trastuzumab deruxtecan (see Special precautions for disposal and other handling under Cautions for Usage).
Trastuzumab deruxtecan is an antibody-drug conjugate (ADC) that contains a humanised anti-HER2 IgG1 monoclonal antibody (mAb) with the same amino acid sequence as trastuzumab, produced by mammalian (Chinese Hamster Ovary) cells, covalently linked to DXd, an exatecan derivative and a topoisomerase I inhibitor, via a tetrapeptide-based cleavable linker. Approximately 8 molecules of deruxtecan are attached to each antibody molecule.
Excipients/Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, Sucrose, Polysorbate 80.
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