Ogivri Description

Trastuzumab (Ogivri) is a sterile, off-white to pale yellow, preservative-free lyophilized powder for injection, for intravenous administration.
Trastuzumab (Ogivri) 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 is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.
Each multiple-dose vial of Trastuzumab (Ogivri) delivers 440 mg trastuzumab, 337.9 mg D-sorbitol, 6.3 mg L-Histidine, 9.9 mg L-Histidine hydrochloride and 98.6 mg Polyethylene glycol 3350/Macrogol 3350. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 20 mL (440 mg trastuzumab), at a pH of approximately 6. If Trastuzumab (Ogivri) is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose.
Each single-dose vial of Trastuzumab (Ogivri) delivers 150 mg trastuzumab, 115.2 mg D-sorbitol, 2.16 mg L-Histidine, 3.36 mg L-Histidine hydrochloride and 33.6 mg Polyethylene glycol 3350/Macrogol 3350. Reconstitution with 7.2 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 150 mg trastuzumab, at a pH of approximately 6.
Excipients/Inactive Ingredients: L-histidine, L-histidine hydrochloride, Polyethylene glycol 3350/macrogol 3350, D-Sorbitol.