BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

Ofatumumab

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)].


FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Medication Guides

Patient Medication Guide - ARZERRA

Patient Medication Guide - KESIMPTA

Package Inserts

Ofatumumab

Updated January 2018