Alemtuzumab (Lemtrada®): Revised indication, additional contraindications and risk minimisation measures

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Alemtuzumab (Lemtrada®) is a disease modifying drug that is indicated in adults with highly active relapsing remitting multiple sclerosis (RRMS). New safety information has been identified from the post-marketing experience of Lemtrada®. These 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.

According to the recent benefit-risk profile review of Lemtrada® in multiple sclerosis, the approved indication has been revised, new contraindications have been added and several risk minimisation measures have been implemented, as summarised below:


Restricted Indication

In Malaysia, the indication for Lemtrada® has been restricted as a single disease modifying therapy in adults with highly active RRMS for the following patient groups:


New Contraindications

Lemtrada® is additionally contraindicated in:


Risk minimisation measures:

Additional risk minimisation measures have been implemented with regards to the:


The prescribing information of Lemtrada® has been updated to reflect the revised indication, additional contraindications and risk minimisation measures.

On 22nd September 2020, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Sanofi-Aventis (M) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.




This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.