Hepatitis B Virus (HBV) Reactivation; Progressive Multifocal Leukoencephalopathy

Hepatitis B Virus (HBV) Reactivation

• 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 (5.4)].

Progressive Multifocal Leukoencephalopathy

• Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions (5.6)].