ADR that result in revision of patient information
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| The United Kingdom: BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation |
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The Medicines and Healthcare products Regulatory Agency (MHRA) advised that patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
BCR-ABL tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib, and ponatinib) are used in the treatment of chronic myeloid leukaemia or Philadelphia chromosome positive acute lymphoblastic leukaemia.
An EU-wide review has shown that cases of HBV reactivation can occur in patients who are chronic carriers of the virus after they have received a BCR-ABL tyrosine kinase inhibitor. Some cases resulted in acute liver failure or fulminant hepatitis, leading to liver transplantation or death. The review assessed cases from clinical studies and cases of suspected adverse drug reactions reported by healthcare professionals and in the literature.
Case reports suggest that HBV reactivation may occur at any time during treatment with a BCR-ABL tyrosine kinase inhibitor. Some patients had a history of hepatitis B, whereas for others the serological status at baseline was unknown. On HBV reactivation, an increase in viral load or positive serology was diagnosed. The risk of HBV reactivation is considered a class effect of BCR-ABL tyrosine kinase inhibitors; however, the mechanism and frequency of virus reactivation during exposure are currently unknown.
The MHRA advised healthcare professionals of the following:
• Test patients for infection with hepatitis B virus (HBV) before starting treatment with BCR-ABL tyrosine kinase inhibitors
• Consult experts in liver disease and in the treatment of HBV before starting treatment with BCR-ABL tyrosine kinase inhibitors in patients with positive HBV serology (including those with active disease) and for patients who test positive for HBV during treatment
• Patients who are carriers of HBV who require treatment with BCR-ABL tyrosine kinase inhibitors should be closely monitored for signs and symptoms of active HBV infection throughout treatment and for several months after stopping
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/bcr-abl-tyrosine-kinase-inhibitors-risk-of-hepatitis-b-reactivation
In Hong Kong, there are 16 registered pharmaceutical products which belong to the class of BCR-ABL tyrosine kinase inhibitors, including 9 containing imatinib, 2 containing nilotinib and 5 containing dasatinib; while there is no registered product containing bosutinib and ponatinib. All these products are prescription only medicines. Related news was previously issued by Singapore HSA and Health Canada, and was posted on the Drug Office website on 31 March 2016 and 5 May 2016 respectively. Letters to inform local healthcare professionals were also issued on both days. So far, the Department of Health (DH) has received four adverse drug reaction cases in connection with BCR-ABL tyrosine kinase inhibitors, of which three involved imatinib and one involved dasatinib. Amongst the cases, there is one case of suspected drug-induced liver injury after taking imatinib. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee). The above MHRA announcement will also be forwarded to the Committee for consideration. DH will remain vigilant on any safety updates from other overseas drug regulatory authorities.
Ends/ Wednesday, May 11, 2016
Issued at HKT 15:00
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