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

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Description

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:

  • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or;
  • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

 

New Contraindications

Lemtrada® is additionally contraindicated in:

  • Patients with severe active infection until complete resolution.
  • Patients with uncontrolled hypertension.
  • Patients with a history of arterial dissection of the cervicocephalic arteries.
  • Patients with a history of stroke.
  • Patients with a history of angina pectoris or myocardial infarction.
  • Patients with known coagulopathy, on antiplatelet or on anticoagulant therapy.
  • Patients with other concomitant autoimmune disease (other than multiple sclerosis).

 

Risk minimisation measures:

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

  • Initiation and administration of Lemtrada®.
  • Infusion instructions to reduce serious reactions temporally associated with Lemtrada®
  • Post-infusion monitoring advice.

 

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.

 

 

DISCLAIMER

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.

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 17 September 2021, 11:54:03.
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