Gazyva Infusion
Obinutuzumab
1000mg/40ml
F. Hoffmann-La Roche Ltd.
| Pack size | 40ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 20212.00 AED |
Indications
Gazyva Infusion is used for:
Indicated for previously untreated, chronic lymphocytic leukemia, in combination with chlorambucil, Follicular Lymphoma, Refractory or relapsed follicular lymphoma
Adult 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 product literature. Pre-medicate with IV corticosteroid, oral analgesic (e.g. acetaminophen)/antipyretics and antihistamine.
Follicular lymphoma
Adult: Induction in combination with chemotherapy in either 6 21/28-day cycles or 8 21-day cycles: 1,000 mg on Cycle 1, Days 1, 8 and 15 and on Cycles 2-6/8, Day 1 at 50-100 mg/hour, increased by 50-100 mg/hour to a max rate of 400 mg/hour.
Maintenance as monotherapy initiated approx 2 months after last induction dose: 1,000 mg every 2 months for 2 years or until disease progression.
In case of toxicity, modify dose according to product literature. Pre-medicate with IV corticosteroid, oral analgesic (e.g. acetaminophen)/antipyretics and antihistamine.
Refractory or relapsed follicular lymphoma
Adult: Induction in combination with bendamustine in 6 28-day cycles: 1,000 mg on Cycle 1, Days 1, 8 and 15 and on Cycles 2-6, Day 1 at 50-100 mg/hour, increased by 50-100 mg/hour to a max rate of 400 mg/hour.
Maintenance as monotherapy initiated approx 2 months after last induction dose: 1,000 mg every 2 months for 2 years or until disease progression.
In case of toxicity, modify dose according to product literature. Pre-medicate with IV corticosteroid, oral analgesic (e.g. acetaminophen)/antipyretics and antihistamine.
Child Dose
Renal Dose
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, use immediately
Clearly label each infusion bag
1000 mg dose
Withdraw 40 mL of solution from the vial
Dilute 40 mL (1000 mg) into a 250 mL 0.9% NaCl infusion bag
Mix diluted solution by gentle inversion; do not shake
For microbiological stability, the diluted infusion solution should be used immediately
The product can be administered at a final concentration of 0.4 mg/mL to 4 mg/mL
If not used immediately, diluted solution may be refrigerated at 2-8°C (36-46°F) for up to 24 hours prior to use
IV Administration
Administer as IV infusion only
Do not administer as IV push or bolus
Do not mix with other drugs
Contra Indications
Hypersensitivity to this drug including serum sickness. Administration of live viral vaccines.
Precautions
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
Pregnancy-Lactation
Interactions
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.
Adverse Effects
Side effects of Obinutuzumab :
>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%)
Mechanism 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
Note
Gazyva 1000mg/40ml Infusion manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Obinutuzumab. Gazyva is availble in United Arab Emirates.
Farmaco UAE drug index information on Gazyva Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.