Article date: December 2013
Rituximab (MabThera) is a treatment for adults with non-Hodgkin’s lymphoma; chronic lymphocytic leukaemia; rheumatoid arthritis; or granulomatosis with polyangiitis and microscopic polyangiitis.
A recent review of all available data has shown that rituximab has been associated with reactivation of hepatitis B virus when used in the indications of cancer and rheumatoid arthritis. These cases included fulminant hepatitis, some of which were fatal.
Analysis showed that rituximab is associated with reactivation of this virus in patients with positive HB surface antigen, and in those with negative HB surface antigen and positive HB core antibody—particularly when given in combination with steroids or chemotherapy.
Advice for healthcare professionals:
- Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications
- Patients with active hepatitis B disease should not be treated with rituximab
- A patient with positive serology for hepatitis B virus should be referred to a specialist in liver disease before starting treatment with rituximab. During treatment, these patients should be monitored and managed to prevent reactivation of the virus
- Please report suspected adverse reactions occurring with rituximab on a Yellow Card (www.mhra.gov.uk/yellowcard)
See letter for healthcare professionals sent November 2013
Summary of Product Characteristics
Article citation: Drug Safety Update volume 7 issue 5, December 2013: A1.
Published 11 December 2014