Revised SPC: Glivec (imatinib) film-coated tablets

SPC now warns that reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors. Patients should be tested for hepatitis B before initiating treatment with nilotinib.

The May Drug Safety Update from MHRA provides following advice:

• 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.