Dear Healthcare Professional Letter on the need for carrying out hepatitis B screening in all patients before treatment with Arzerra (ofatumumab)
13.01.2014
GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter with new recommendations related to the screening of patients for hepatitis B antigen before the ofatumumab treatment.
Summary:
- After reported cases of infection and reactivated hepatitis B virus (HBV) in patients treated with anti-CD20 monoclonal antibodies, from now on it is recommended to screen all patients for HBV infection before the ofatumumab treatment.
- Patients with an active hepatitis virus B infection should not be treated with ofatumumab.
- In patients with positive serology of HBV ( but not with active disease), a hepatologist specialist should be consulted to monitor and start an HBV antiviral treatment.
- In patients who develop an HBV reactivation during the ofatumumab treatment, the use of ofatumumab and any other concomitant chemotherapy should be immediately discontinued and appropriate treatment for HBV started.
Additional information
A recent review of anti-CD20 monoclonal antibody treatment has shown that in patients treated with medicines classified as CD20-dyrected cytolytic antibodies, including ofatumumab, HBV reactivation and infection occurred, which in some cases resulted in fulminant hepatitis, hepatic failure and death.
Cases of HBV infection and virus reactivation have been reported in patients with a positive surface antigen (HBsAg) as well as in those with positive hepatitis b "core” antibody (anti-HBc) that were HBsAg negative. The reactivation occurred in patients where HBV infection was apparently cured (that is HBsAg negative, anti-HBc positive and positive antibodies for hepatitis B surface antigen).
Due to the above, it is recommended to screen all patients for HBV (and not only those with a risk of HBV infection), before starting the ofatumumab treatment in all indications. In patients with a proven previous HBV infection, a hepatologist specialist should be consulted in order to monitor and start the HBV antiviral treatment. The Summary of Products Characteristics fr Arzerra has been changed to include these new recommendations.
Here you may view the Dear Healthcare Professional Letter.
HALMED has not received any adverse reaction report to Arzerra associated with an infection or reactivation of the hepatitis B virus. HALMED will continue to monitor the safe use of Arzerra and inform the public promptly about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
