GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)
1. Approved Labelling
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil for the treatment of patients with previously untreated Chronic Lymphocytic Leukemia (CLL)
2. Treatment Regimen
- Premedicate with glucocorticoid, acetaminophen and anti-histamine
- Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus.
Each dose of Gazyva is 1000 mg, administered intravenously, with the exception of the first infusions in Cycle 1, which are administered on day 1 (100 mg) and day 2 (900 mg).
Dose of Gazyva to Be Administered During 6 Treatment Cycles, Each of 28 days Duration, for Patients with CLL
|Day of treatment cycle||Dose of Gazyva||Rate of infusion (in the absence of infusion reactions/hypersensitivity during previous infusions)|
|Cycle 1 (loading doses)||Day 1||100 mg||Administer at 25 mg/hr over 4 hours. Do not increase the infusion rate.|
|Day 2||900 mg||Administer at 50 mg/hr. The rate of the infusion can be escalated in increments of
50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
|Day 8||1000 mg||If no infusion reaction occurred during the previous infusion and the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.|
|Day 15||1000 mg|
|Cycles 2-6||Day 1||1000 mg|
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.
Please see section 5 of the PI.
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