Drug Safety Update - Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions

Patients offered alemtuzumab should be alerted to the early risks of CV events and thrombocytopenia around the time of infusion and to the delayed risk of immune-mediated reactions. Healthcare professionals should inform patients what to do if they develop any symptoms.

SPS commentary:

The alert highlights a revised indication for alemtuzumab, additional contraindications, and strengthened monitoring requirements before, during and after treatment.


Medicines and Healthcare products Regulatory Agency