Alemtuzumab (Lemtrada): Risks of immune-mediated reactions and serious cardiovascular adverse events occurring in close temporal association with Lemtrada infusions

A Dear Healthcare Professional Letter has been issued by Sanofi-aventis to inform healthcare professionals of new safety information on the risks of immune-mediated reactions (e.g. autoimmune hepatitis and haemophagocytic lymphohistiocytosis) and serious cardiovascular adverse events (e.g. myocardial ischemia, stroke and cervicocephalic arterial dissection) occurring in close temporal association with Lemtrada (alemtuzumab) infusions. In light of this emerging data, healthcare professionals are advised to follow the new risk minimisation measures before and during treatment with alemtuzumab. These new measures include the monitoring of vital signs before and periodically during alemtuzumab infusion and the evaluation of liver function prior to starting treatment and periodically thereafter, as per clinical judgment. Patients should be informed about the signs and symptoms of these adverse reactions and to seek medical attention should they occur. Sanofi-aventis will be working with HSA to incorporate the new safety information into the Singapore Lemtrada package insert. Please refer to the letter for details. Published: 24 Jun 2019

Dear Healthcare Professional Letters