SPL Set ID: ce2a2492-85e3-4b0a-872a-047f44e4203d

Trastuzumab-dttb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dttb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ontruzant (trastuzumab-dttb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of Ontruzant delivers 420 mg trastuzumab-dttb, 381.4 mg α,α-trehalose dihydrate, 9.4 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb at a pH of approximately 6. If Ontruzant is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ontruzant delivers 150 mg trastuzumab-dttb, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb that delivers 7.15 mL (150 mg trastuzumab-dttb), at a pH of approximately 6.