Swissmedic, Swiss agency for the authorisation and supervision of therapeutic products (medicinal products and medical devices), announced on 17 August 2016 that the marketing authorisation holders of tyrosine kinase inhibitors (TKIs) targeting the BCR-ABL bosutinib (Bosulif®), dasatinib (Sprycel®), imatinib (Gleevec®, Glivec® GIST, Imatinib Sandoz, Imatinib Teva®, Imatinib Zentiva®), nilotinib (Tasigna®), and ponatinib (Iclusig®) communicated about potential risk of hepatitis B virus (HBV) reactivation after treatment with these drugs.
In patients who are chronic HBV carriers, cases of HBV reactivation have occurred after receiving the TKIs targeting the BCR-ABL. Some cases of HBV reactivation induced acute liver failure or fulminant hepatitis, which led to a liver transplant or death.
Patients should be tested for the presence of HBV infection before initiating treatment with TKI targeting the BCR-ABL.
Experts in the field of liver disease and with experience in the treatment of HBV infection should be consulted prior to initiating therapy with TKIs targeting the BCR-ABL in patients with positive serology for HBV, including those patients with active disease, and in patients with a positive test for HBV infection during the treatment.
The HBV carriers who require treatment with TKIs targeting the BCR-ABL TKIs should be closely monitored for any signs or symptoms of active HBV infection throughout the treatment and several months after discontinuation of treatment.
The marketing authorisation holders of these BCR ABL TKIs are Ariad Pharmaceuticals (Europe) Sàrl, Bristol-Myers Squibb SA, Novartis Pharma Switzerland AG, Pfizer AG, Helvepharm AG, Sandoz Pharmaceuticals AG and Teva Pharma AG.