Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) refractory to fludarabine and alemtuzumab
Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)
1. Approved Labelling
Arzerra (ofatumumab) is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) refractory to fludarabine and alemtuzumab.
2. Treatment Regimen
- Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus
- Recommended dose and schedule is 12 doses administered as follows:
- 300 mg initial dose, followed 1 week later by
- 2,000 mg weekly for 7 doses, followed 4 weeks later by
- 2,000 mg every 4 weeks for 4 doses
- Infusion 1 (300-mg dose): Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour).
- Infusion 2 (2,000-mg dose): Initiate infusion at a rate of 24 mg/hour (12 mL/hour).
- Infusions 3 through 12 (2,000-mg doses): Initiate infusion at a rate of 50 mg/hour (25 mL/hour).
Premedicate with oral acetaminophen, oral or intravenous antihistamine, and intravenous corticosteroid
Please see section 5 of the PI
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