Tasigna® (nilotinib)- Need to screen patients for hepatitis B virus (HBV) infection before treatment due to risk of HBV reactivation

Novartis would like to inform healthcare professionals of the risk of hepatitis B (HBV) reactivation associated with the use of Tasigna^® (nilotinib) in patients who are chronic HBV carriers. Cases of reactivation of HBV can occur in patients who are chronic carriers of this virus after receiving BCR-ABL tyrosine kinase inhibitors (TKIs), such as imatinib. Case reports indicate that HBV reactivation may occur at any time during BCR-ABL TKIs treatment. Some of these cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome. Healthcare professionals are advised to test patients for HBV infection before initiating treatment with imatinib. Patients currently on imatinib should have baseline testing for HBV infection in order to identify chronic carriers of the virus. Experts in liver disease and in the treatment of HBV should be consulted before treatment is initiated in patients with positive HBV serology (including those with active disease) and for patients who test positive for HBV infection during treatment. Carriers of HBV who require treatment with imatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. The local package inserts for Tasigna^® products will be updated with the new information.

Published: 28 Mar 2016

Dear Healthcare Professional Letters