Hepatitis B Reactivation Prompts New Warnings for Arzerra, Rituxan

The FDA has approved changes to the prescribing information for Arzerra (ofatumumab; GlaxoSmithKline) and Rituxan (rituximab; Genentech) to add a new warning about the risk of hepatitis B virus (HBV) infection reactivation.

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Arzerra is a cytolytic monoclonal antibody (CD20-directed) indicated for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab. Rituxan is a B-lymphocyte-restricted differentiation antigen [CD20] inhibitor indicated for various lymphomas and leukemias, immune disorders, and rheumatoid arthritis.

The updated labels will include additional recommendations for screening, monitoring, and managing patients to decrease this risk. Reactivation can cause serious liver problems, including liver failure and death. 

HBV reactivation is being added to the existing Boxed Warning of the Rituxan label, and a new Boxed Warning is being created for the Arzerra label to describe the risk.  The Warnings and Precautions section also is being revised for each drug to express new recommendations.

Healthcare professionals are recommended to:

• Screen all patients for HBV infection before starting treatment by measuring HBsAg and anti-HBc levels
• Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when at-risk patients are identified
• Monitor patients with prior HBV infection during therapy and for several months thereafter
• Immediately discontinue the drug and treat HBV if reactivation occurs; also discontinue any chemotherapy the patient is receiving

For more information call (888) 332-1088 or read the FDA’s Drug Safety Communication.