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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.
| Mechanism of Action:
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 lysis through engagement of immune effector cells, by directly activating intracellular death signaling pathways and/or activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
| INDICATIONS AND USAGE:
GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)
| WARNINGS AND PRECAUTIONS: [see package insert for more detailed comments]
| ADVERSE REACTIONS:
The most common adverse reactions (incidence ≥10%) were: infusion reactions, neutropenia, thrombocytopenia, anemia, pyrexia, cough, and musculoskeletal disorder.
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION: -----------------------
Recommended Dosage Regimen
Table 1 Dose of GAZYVA to be administered during 6 treatment cycles each of 28 days duration
If a planned dose of GAZYVA is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly. If appropriate, patients who do not complete the Day 1 Cycle 1 dose may proceed to the Day 2 Cycle 1 dose.
If a patient experiences an infusion reaction of any grade during infusion, adjust the infusion as follows [see Warnings and Precautions]:
Hypotension may occur during GAZYVA intravenous infusions. Consider withholding antihypertensive treatments for 12 hours prior to and throughout each GAZYVA infusion and for the first hour after administration [see Warnings and Precautions].
For patients with high tumor burden and/or high circulating absolute lymphocyte counts (greater than 25 x 109/L), premedicate with anti-hyperuricemics (e.g., allopurinol) beginning 12-24 hours prior to start of therapy and ensure adequate hydration for prophylaxis of tumor lysis syndrome [see Warnings and Precautions ].
Table 2 Premedication for GAZYVA Infusion to Reduce Infusion-Related Reactions
*Hydrocortisone is not recommended as it has not been effective in reducing the rate of infusion reactions.
Premedication for anti-microbial prophylaxis
Treatment Interruption for Toxicity
Preparation and Administration-----------------------------------
The product can be administered at a final concentration of 0.4 mg/mL to 4 mg/mL.
| DOSAGE FORMS AND STRENGTHS:
1000 mg/40 mL (25 mg/mL) single use vial.
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.
For the diluted product, chemical and physical stability have been demonstrated in 0.9% NaCl at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C (36°F to 46°F) followed by 48 hours (including infusion time) at room temperature (≤ 30°C/86°F). GAZYVA does not contain antimicrobial preservatives. Therefore care must be taken to ensure that the solution for infusion is not microbiologically compromised during preparation. The solution for infusion should be used immediately. If not used immediately, the prepared solution may be stored up to 24 hours at 2-8°C. No incompatibilities between GAZYVA and polyvinyl chloride or polyolefin infusion materials have been observed in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of GAZYVA with 0.9% sodium chloride.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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