Glivec® (imatinib) & Tasigna® (nilotinib): Risk of Hepatitis B reactivation


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Date: 25 April 2016



A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of the risk of HBV reactivation in patients who are chronic carriers of this virus after receiving a BCR-ABL tyrosine kinase inhibitor (TKI), such as imatinib and nilotinib. Patients should be tested for hepatitis B infection before initiating treatment with imatinib or nilotinib. Patients currently on imatinib or nilotinib should also have baseline testing for hepatitis B infection. Experts in liver disease and in the treatment of hepatitis B should be consulted in patients with positive hepatitis B serology (including those with active disease). Carriers of HBV who require treatment with imatinib or nilotinib should be closely monitored for signs and symptoms of active hepatitis B infection throughout therapy and for several months following termination of therapy. Please refer to the DHPC issued by Novartis Corporation (M) Sdn. Bhd. for further information.