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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use ARZERRA safely and effectively. See full prescribing information for ARZERRA.
ARZERRA (ofatumumab)
Injection, for intravenous infusion
Initial U.S. Approval: 2009
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RECENT MAJOR CHANGES
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Dosage and Administration, Preparation and Administration (2.5) |
04/2011 |
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Warnings and Precautions, HepatitisB Infection and Reactivation (5.4) |
09/2011 |
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INDICATIONS AND USAGE
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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. The effectiveness of ARZERRA is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA. (1, 14)
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DOSAGE AND ADMINISTRATION
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