Gazyva
Injection
Roche Bangladesh Ltd.Generic:
ObinutuzumabWeight:
1000 mg/40 mlbest Price:
? 112,000.00Generic
Obinutuzumab
Indications
Chronic Lymphocytic Leukemia (CLL): Obinutuzumab in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. Follicular Lymphoma (FL): Obinutuzumab in combination with chemotherapy, followed by Obinutuzumab maintenance is indicated for the treatment of patients with previously untreated follicular lymphoma. Obinutuzumab in combination with bendamustine, followed by Obinutuzumab maintenance, is indicated for the treatment of patients with FL who did not respond to, or who progressed during or after treatment with rituximab or a rituximab-containing regimen.
Pharmacology
Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysisthrough (1) engagement of immune effector cells (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibodydependent cellular phagocytosis. As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines. Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab. Obinutuzumab binds to Fc?RIII using purified proteins with a higher affinity than rituximab. Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.
Contraindications
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Side Effects
Pediatric Use: The safety and efficacy of Obinutuzumab in children below 18 years of age have not been established. Geriatric Use: Chronic Lymphocytic Leukemia (CLL): In the pivotal study in CLL, 46% (156 out of 336) of patients treated with Obinutuzumab plus chlorambucil were 75 years old or older (median age was 74 years). These patients experienced more serious adverse events and adverse events leading to death than patients <75 years of age. No significant differences in efficacy were observed between patients ?75 years of age and those <75 years of age Non-Hodgkin Lymphoma (NHL): In the pivotal studies in NHL, patients 65 years old or older experienced more serious adverse events, and adverse events leading to withdrawal or death than patients <65 years of age. No clinically meaningful differences in efficacy were observed.
Pregnancy And Lactation
Anti neoplastic preparations
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