Source: FDA, National Drug Code (US) Revision Year: 2024
Trastuzumab-strf 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. Trastuzumabstrf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product.
Hercessi (trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration.
Each single-dose vial of Hercessi delivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6.
| Dosage Forms and Strengths |
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For injection: 150 mg white to pale yellow lyophilized powder with a cake-like appearance in a singledose vial. |
| How Supplied |
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150 mg Single-dose vialHercessi (trastuzumab-strf) for injection 150 mg/vial is supplied in a single-dose vial as a white to pale yellow lyophilized sterile powder with a cake-like appearance, under vacuum. Each carton contains one single-dose vial of Hercessi. NDC 69448-015-05. Manufactured at: Shanghai Henlius Biologics Co., Ltd., Building 1, No. 182 Wenjun Road, Songjiang District, Shanghai, China Manufactured by: Accord BioPharma Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC, 27617 USA, U.S. License No. 2105 |
| Drug | Countries | |
|---|---|---|
| HERCESSI | United States |
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