Publications

Published: 6 September 2013

Rituximab and Hepatitis B Reactivation

Prescriber Update 34(3):27
September 2013

Key Messages

  • Rituximab has been associated with cases of hepatitis B reactivation.
  • All patients should be screened for hepatitis B virus before initiation of treatment with rituximab.
  • Rituximab should not be used in patients with active hepatitis B.
  • Healthcare professionals should consult with a liver specialist prior to initiating rituximab treatment in patients with positive hepatitis B serology.


Hepatitis B virus screening is now recommended for all patients before initiating treatment with rituximab (Mabthera) for all oncology and rheumatoid arthritis indications. Previously, only patients that were at high risk for hepatitis B virus infection were recommended for screening prior to starting treatment.

Cases of hepatitis B reactivation, including fulminant hepatitis, have been reported worldwide in subjects receiving rituximab. Patients with positive hepatitis B surface antigen (HBsAg+ve) and patients with negative hepatitis B surface antigen and positive anti-hepatitis B core antibody (HBsAg-ve/HBcAb+ve) have reported hepatitis B reactivation, particularly when administered in combination with steroids or chemotherapy. Some of these cases were fatal.

Healthcare professionals should consult with a liver specialist prior to initiating rituximab treatment in patients with positive hepatitis B serology as patients will need to be monitored and managed to prevent hepatitis B reactivation. Patients with active hepatitis B disease should not be treated with rituximab.

Rituximab is an anti-CD20 monoclonal antibody. Rituximab binding to CD20 results in complete but transient depletion of B cells from peripheral circulation1.


Rituximab is approved for use in New Zealand for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis. Worldwide, cases of hepatitis B reactivation have been reported in patients treated for both the oncology and the rheumatoid arthritis indications.

The Centre for Adverse Reactions Monitoring (CARM) has received one report of hepatitis B reactivation following treatment with rituximab. In this report, rituximab was used to treat lymphoproliferative disease that developed following a liver transplant.

The sponsor of rituximab, Roche Products (New Zealand) Limited, has sent out a dear healthcare professional letter informing healthcare professionals of this issue. The warnings and precautions section of the New Zealand data sheet has been updated to include the new recommendations1.

References
  1. Roche Products (New Zealand) Ltd. 2013. Mabthera Data Sheet. 26 June 2013. URL: www.medsafe.govt.nz/profs/datasheet/m/Mabtherainf.pdf (accessed 5 August 2013).