Lemtrada (alemtuzumab): Revised indications, additional contraindications and risk minimisation measures

A Dear Healthcare Professional Letter has been issued by Sanofi-aventis Singapore Pte Ltd to inform healthcare professionals of the revised indications, additional contraindications and risk minimisation measures for the use of Lemtrada® (alemtuzumab). These changes follow new safety information identified from the post-marketing use of Lemtrada and a recent assessment of its benefit-risk profile. The new safety information include reports of myocardial ischaemia, myocardial infarction, haemophagocytic lymphohistiocytosis (HLH), autoimmune hepatitis, acquired haemophilia A, Epstein-Barr virus (EBV) reactivation, haemorrhagic stroke, dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage and thrombocytopenia. Following a review of the benefit-risk profile of Lemtrada, additional risk minimisation measures will be introduced with respect to 1) the initiation and administration of Lemtrada; 2) infusion instructions to reduce serious reactions temporally associated with Lemtrada infusion; and 3) post-infusion monitoring advice. Updates to the Singapore Lemtrada® package insert to include the above events as well as the risk minimisation measures are provided in the letter. Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

15 Jul 2020

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.