Facts of Gazyva 1000mg Vial ?
- Medicine Name: GAZYVA
- Medicine Name: Obinutuzumab
- Date of Approval:
- Company Name: Genentech, Inc.
GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)
GAZYVA (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 is produced by mammalian cell (CHO) suspension culture. GAZYVA is a sterile, clear, colorless to slightly brown, preservative free liquid concentrate for intravenous administration. GAZYVA is supplied at a concentration of 25 mg/mL in 1000 mg single use 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.
GAZYVA 1000 mg/40 mL (25 mg/mL) single-use vials containing preservative-free solution (NDC 50242-070-01) are stable at 2°C to 8°C (36°F to 46°F). Do not use beyond expiration date stamped on carton. GAZYVA vials should be protected from light. DO NOT FREEZE. DO NOT SHAKE.