Source: FDA, National Drug Code (US) Revision Year: 2021
Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa.
GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered for reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. The product is formulated in 20 mM L-histidine/L-histidine hydrochloride, 240 mM trehalose, 0.02% poloxamer 188. The pH is 6.0.
| Dosage Forms and Strengths |
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Injection: 1,000 mg/40 mL (25 mg/mL) clear, colorless to slightly brown solution in single-dose vial. |
| How Supplied |
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GAZYVA is a clear, colorless to slightly brown, preservative-free solution for intravenous use supplied as 1,000 mg/40 mL (25 mg/mL) in single-dose vials (NDC 50242-070-01). Manufactured by: Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990, U.S. License No. 1048 |
| Drug | Countries | |
|---|---|---|
| GAZYVA | Australia, Brazil, Canada, Ecuador, Hong Kong, Israel, Japan, New Zealand, Singapore, Turkey, United States |
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