Paul-Ehrlich-Institut

Lem­tra­da (Alem­tuzum­ab)– PRAC Rec­om­mends Mea­sures to Min­imise Risk of Se­ri­ous Side Ef­fects

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS). The recommendations are based on the results of a recent safety review in which the reports of rare but serious, sometimes fatal adverse events were reviewed.

Adverse reactions reported include immune-mediated diseases as well as severe cardiovascular and stroke events that may occur during or within a few days after the infusion of Lemtrada. In contrast, immune-mediated diseases have latency after infusion with Lemtrada.

Therefore, the PRAC has recommended restricting the use of Lemtrada to

  • adult patients with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or
  • patients in which the disease is worsening rapidly,

    • defined by two or more relapses of disability progression in one year, and with on or more gadolinium-enriching lesions in the MRI of the brain
    • or with a significant increase in T2 lesions compared to recent MRI.

In addition, Lemtrada must no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.

The PRAC has recommended new measures for identifying and promptly dealing with adverse effects that might occur after treatment with Lemtrada. It should be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.

Also, the PRAC has recommended updating the physician’s guide and the patient information pack with advice to minimise the risk of serious heart, circulation and bleeding disorders that may occur shortly after the infusion (drip) as well as autoimmune conditions that could occur many months after the last Lemtrada treatment.

The new recommendations replace the temporary measures issued in April 2019 while the PRAC’s review was under way.

Updated: 01.11.2019