Ofatumumab: screen for hepatitis B virus before treatment
- Medicines and Healthcare products Regulatory Agency
- 15 January 2014
- Therapeutic area:
- Cancer, GI, hepatology and pancreatic disorders, and Haematology
Patients with active infection with this virus should not be treated with ofatumumab.
Article date: January 2014
Ofatumumab (Arzerra) is indicated for the treatment of chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab. Ofatumumab is a monocolonal antibody that acts against CD20.
A recent review of CD20 monoclonal antibodies (ofatumumab and rituximab) has identified cases of hepatitis B virus infection and reactivation in patients treated with these drugs, including ofatumumab. We recently issued advice regarding this risk for rituximab.
These cases included fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who were positive for hepatitis surface antigen, and in those who were negative for this surface antigen but positive for hepatitis B core antibody. Reactivation has occurred in patients who seemed to have resolved hepatitis B infection.
Advice for healthcare professionals:
- All patients should be screened for hepatitis B virus infection before starting treatment with ofatumumab
- Patients with active hepatitis B infection should not be treated with ofatumumab
- Patients with positive hepatitis B serology (but no active disease) should be referred to a specialist in liver disease for consultation about monitoring and initiation of antiviral treatment for hepatitis B before starting treatment with ofatumumab
- If reactivation of hepatitis B virus occurs, ofatumumab and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted
- Please report suspected adverse reactions occurring with ofatumumab on a Yellow Card (www.mhra.gov.uk/yellowcard)
See letter for healthcare professionals sent in December 2013
Article citation: Drug Safety Update volume 7 issue 6, January 2014: A2.
Published: 15 January 2014