Other safety alerts
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| Singapore: Glivec® (imatinib) - Need to screen patients for hepatitis B virus (HBV) infection before treatment due to risk of HBV reactivation |
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The Health Sciences Authority (HSA) announced that Novartis would like to inform healthcare professionals of the risk of hepatitis B (HBV) reactivation associated with the use of Glivec® (imatinib) 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 of the following:
• Patients should be tested 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 package inserts for Glivec® products in Singapore have been updated with the new information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../glivec-imatinib-needtoscreenpatientsforhepatitisbvirushbvinfecti.html
In Hong Kong, Glivec Cap 100mg (HK-49431) is a registered pharmaceutical product, and is a prescription only medicine which is registered by Novartis Pharmaceuticals (HK) Limited (Novartis). So far, the Department of Health (DH) has received two adverse drug reaction cases in connection with the product, but neither of them was related to HBV reactivation. On 10 March 2016, Novartis notified DH that the company was going to issue letters to inform local healthcare professionals. In view of the HSA announcement, DH will issue letters to inform local healthcare professionals, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, March 31, 2016
Issued at HKT 17:00
Novartis confirmed with DH that letters to inform healthcare professionals of the above matter has been issued by the company on 14 April 2016.
Content last updated: Wednesday, April 20, 2016 |
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