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
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning.
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Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.2)
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Progressive Multifocal Leukoencephalopathy (PML) resulting in death. (5.4)
RECENT MAJOR CHANGES
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Boxed Warning
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09/2013
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Indications and Usage (1)
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04/2014
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Dosage and Administration (2)
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04/2014
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Warnings and Precautions (5)
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04/2014
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INDICATIONS AND USAGE
ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated:
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in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate. ( 1.1)
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for the treatment of patients with CLL refractory to fludarabine and alemtuzumab. ( 1.2)
DOSAGE AND ADMINISTRATION
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Dilute and administer as an intravenous infusion. Do not administer subcutaneously or as an intravenous push or bolus. ( 2.1)
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Previously untreated CLL recommended dosage and schedule is:
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300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
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1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles. ( 2.1)
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Refractory CLL recommended dosage and schedule is:
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300 mg initial dose, followed 1 week later by
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2,000 mg weekly for 7 doses, followed 4 weeks later by
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2,000 mg every 4 weeks for 4 doses. ( 2.1)
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Administer where facilities to adequately monitor and treat infusion reactions are available. ( 2.2)
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Premedicate with acetaminophen, antihistamine, and corticosteroid. ( 2.4)
DOSAGE FORMS AND STRENGTHS
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100 mg/5 mL single-use vial for intravenous infusion. ( 3)
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1,000 mg/50 mL single-use vial for intravenous infusion. ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
