HER2 Support Group Forums - View Single Post - Bio similars to Herceptin-are THEY fully humanized????

Lani · 12-24-2017, 08:13 PM

DESCRIPTION

Ogivri (trastuzumab-dkst) 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-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.

Ogivri (trastuzumab-dkst) is a sterile, off-white to pale yellow, preservative-free lyophilized powder for injection, for intravenous administration.

Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, 322.6 mg D-sorbitol, 6.0 mg L-Histidine, 9.4 mg L-Histidine hydrochloride monohydrate and 94.1 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-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose.

12-24-2017, 08:13 PM	#4
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	Re: Bio similars to Herceptin-are THEY fully humanized???? DESCRIPTION Ogivri (trastuzumab-dkst) 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-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) is a sterile, off-white to pale yellow, preservative-free lyophilized powder for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, 322.6 mg D-sorbitol, 6.0 mg L-Histidine, 9.4 mg L-Histidine hydrochloride monohydrate and 94.1 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-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose.