Two Post-Marketing Reports of Progressive Multifocal Leukoencephalopathy (PML) in Patients with Systemic Lupus Erythematosus (SLE) treated with Benlysta® (belimumab)

GlaxoSmithKline (GSK) would like to notify healthcare professionals of important new safety information associated with Benlysta®. Two post-marketing cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving Benlysta®, mycophenolate mofetil and steroids for the treatment of Systemic Lupus Erythematosus (SLE), of which one case was fatal. Healthcare providers are advised to consider a diagnosis of PML in any patient, treated with Benlysta®, presenting with new onset or deteriorating neurological signs and symptoms. The patient should be referred to a neurologist or other appropriate specialist for evaluation and if PML is confirmed, consideration should be given to stopping immunosuppressant therapy, including Benlysta®. GSK is updating the labelling for Benlysta®, given the risk of PML in SLE patients and the importance of making the correct diagnosis and appropriate medical intervention quickly. The benefit-risk profile of Benlysta® remains unchanged and GSK will continue to evaluate the potential for a causal association of PML with Benlysta®. Please refer to the letter for more information. 

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.