Direct healthcare professional communication on the new important advice regarding viral reactivation with use of lenalidomide (Revlimid)
08.11.2016
Celgene Europe Limited, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the new important advice regarding viral reactivation with use of lenalidomide (Revlimid).
Summary
- Cases of viral reactivation have been reported following treatment with lenalidomide, particularly in patients previously infected with the herpes zoster or hepatitis B viruses (HBV).
- Some cases of HBV reactivation progressed to acute hepatic failure and resulted in death.
- Hepatitis B virus status should be established before initiating treatment with lenalidomide.
- Treatment for patients who test positive for HBV infection should be supervised by a physician with expertise in the treatment of hepatitis B.
- Previously infected patients should be closely monitored for signs and symptoms of viral reactivation, including active HBV infection, throughout therapy.
Further information
Revlimid is indicated for the treatment of certain adult patients with multiple myeloma, transfusion-dependent anaemia due to myelodysplastic syndromes as well as mantle cell lymphoma.
The communication provides healthcare professionals with more detailed information on the reported cases of viral reactivation, risk factors for reactivation and new recommendations regarding the risk of viral reactivation.
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.
