ARZERRA
ofatumumab
Product profile Marketed injection, solution containing OFATUMUMAB.
Dose form and route INJECTION, SOLUTION · INTRAVENOUS
Structured Monograph
Clinical summary
Product profile Marketed injection, solution containing OFATUMUMAB. Dose form and route INJECTION, SOLUTION · INTRAVENOUS
Boxed Warning
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions (5.2)] . Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions (5.4)] . WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.4 )
Monitoring
- • Monitor patients during infusions.
- • Interrupt infusion if infusion reactions occur.
- • ( 2.3 , 2.4 , 5.1 ) Tumor Lysis Syndrome: Anticipate TLS in high-risk patients; pre-medicate with anti-hyperuricemics and hydration.
- • Review the product-specific label before prescribing.
Interaction Notes
- • Interaction data should be confirmed against the corresponding label.