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Gazyva
Roche Bangladesh Pharmaceutical
Generic: Obinutuzumab
Medicine Overview of Gazyva 1000mg/40ml Injection
বাংলা
English
Indication
Indicated for previously untreated, chronic lymphocytic leukemia, in combination with chlorambucil, Follicular Lymphoma, Refractory or relapsed follicular lymphoma
Administration
IV Preparation Inspect visually for any particulate matter and discoloration prior to administration Dilute into 0.9% NaCl PVC or non-PVC polyolefin infusion bag Do not use other diluents (eg, dextrose 5%) Dilute under appropriate aseptic conditions 100 mg and 900 mg doses Withdraw 40 mL of solution from the vial Dilute 4 mL (100 mg) into 100 mL 0.9% NaCl infusion bag for immediate administration Dilute the remaining 36 mL (900 mg) into a 250 mL 0.9% sodium chloride infusion bag at the same time for use on Day 2 After allowing the diluted bag to come to room temperature,...
... Show moreAdult Dose
Intravenous Chronic lymphocytic leukaemia Adult: In combination with chlorambucil in 6 28-day cycles: CYCLE 1: Day 1: 100 mg at 25 mg/hour over 4 hours; Day 2: 900 mg at 25-50 mg/hour, increased by 50 mg/hour every 30 minutes to a max rate of 400 mg/hour; Days 8 and 15: 1,000 mg at 50-100 mg/hour, increased by 50-100 mg/hour every 30 minutes to a max rate of 400 mg/hour. CYCLE 2-6: Day 1: 1,000 mg at 50-100 mg/hour, increased by 50-100 mg/hour every 30 minutes to a max rate of 400 mg/hour. In case of toxicity, modify dose according to...
... Show moreContraindication
Hypersensitivity to this drug including serum sickness. Administration of live viral vaccines.
Mode of Action
CD20-directed cytolytic antibody; upon binding to CD20, obinutuzumab mediates B-cell lysis through 1) engagement of immune effector cells, 2) by directly activating intracellular death signaling pathways and/or, 3) activation of the complement cascade
CD20 antigen is expressed on the surface of pre B- and mature B-lymphocytes; the immune effector cell mechanisms include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis
Precaution
Patient with history or current serious infection especially hepatitis B virus (HBV) infection, risk of tumour lysis syndrome (e.g. high tumour burden, high lymphocyte count), cardiac and respiratory impairment. Renal impairment. Pregnancy and lactation.
Lactation
Unknown if distributed in human breast milk
Excreted in the milk of lactating cynomolgus monkeys and human IgG is known to be excreted in human milk; consider developmental and health benefits along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant
Side Effect
>10%
Infusion related reactions (69%)
Neutropenia (33%)
Hypocalcemia (32%)
Hyperkalemia (31%)
Hyponatremia (29%)
Creatinine increased (28%)
AST/SGOT increased (28%)
AST/SGPT increased (25%)
Hypoalbuminemia (16%)
Alkaline phosphatase increased (16%)
Thrombocytopenia (15%)
Hypokalemia (13%)
Anemia (12%)
1-10%
Pyrexia (10%)
Cough (10%)
Leukopenia (7%)
Tumor lysis syndrome (2%)
Interaction
May increase risk of hypotension with antihypertensive agents. May increase risk of haemorrhage with anticoagulants, platelet inhibitors.
Potentially Fatal: May enhance the adverse effects and diminish the therapeutic effects of live vaccines.
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