- Medicines and Healthcare products Regulatory Agency
- 10 May 2016
- Therapeutic area:
- Cancer, Haematology, and Immunosuppression and transplantation
Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
Advice for healthcare professionals:
- 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
- Suspected adverse drug reactions to BCR-ABL tyrosine kinase inhibitors should be reported to us on a Yellow Card
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. Full details of authorised indications are given in individual Summaries of Product Characteristics.1
Cases of HBV reactivation
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.
Letter sent to healthcare professionals 11 April 2016
EU Pharmacovigilance Risk Assessment Committee (PRAC) recommendations on updates to product information for BCR-ABL tyrosine kinase inhibitors
Article citation: Drug Safety Update vol 9 issue 10, May 2016: 1.
Published: 10 May 2016