Enhertu Description

ENHERTU Powder for Concentrate for Solution for Infusion 100 mg: One vial of lyophilized powder for concentrate for solution for infusion delivers 100 mg of trastuzumab deruxtecan. After reconstitution, one vial of 5 mL solution delivers 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) composed of three components: 1) a humanized anti-HER2 IgG1 monoclonal antibody (mAb) with the same amino acid sequence as trastuzumab, covalently linked to 2) a topoisomerase I inhibitor, an exatecan derivative, via 3) a tetrapeptide-based cleavable linker. Deruxtecan is composed of the linker and the topoisomerase I inhibitor.
The antibody is produced in Chinese hamster ovary cells by recombinant DNA technology and the topoisomerase I inhibitor and linker are produced by chemical synthesis. Approximately 8 molecules of deruxtecan are attached to each antibody molecule.
Excipients/Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, Sucrose, Polysorbate 80.