Direct healthcare professional communication on the need to screen patients for hepatitis B virus before treatment due to risk of hepatitis B reactivation with BCR-ABL tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib, ponatinib)
11.04.2016
Novartis Hrvatska d.o.o., Amicus Croatia d.o.o., Alpha-Medical d.o.o., Pliva Hrvatska d.o.o., Alvogen d.o.o., Belupo, lijekovi i kozmetika d.d. and Krka - farma d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals of the need to screen patients for hepatitis B virus before treatment due to risk of hepatitis B reactivation with BCR-ABL tyrosine kinase inhibitors.
Summary
- Cases of reactivation of hepatitis B virus (HBV) have occurred in patients who are chronic carriers of HBV after they received BCR-ABL tyrosine kinase inhibitors (TKIs). Some cases of HBV reactivation resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
- Patients should be tested for HBV infection before initiating treatment with BCR-ABL TKIs.
- Experts in liver disease and in the treatment of HBV should be consulted before treatment in patients with positive HBV serology (including those with active disease) is initiated and for patients who test positive for HBV infection during treatment.
- Patients who are carriers of HBV requiring treatment with BCR-ABL TKIs should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Further information
This group of medicinal products affects cell functions in cancer cells in several malignant diseases by inhibiting BCR-ABL tyrosine kinase.
It is considered that HBV reactivation is a class-effect of BCR-ABL tyrosine kinase inhibitors, although the mechanism and the frequency of HBV reactivation during exposure to the medicinal product are currently unknown.
As recommended by the National Competent Authorities and the European Medicines Agency (EMA), the summary of product characteristics (SmPC) and the package leaflet of all BCR-ABL TKIs will be updated to reflect the new safety information.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
