EMA restricts use of MS drug alemtuzumab

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is currently conducting a review of the safety of the multiple sclerosis (MS) medicine alemtuzumab (Lemtrada). The EMA has restricted the use of the drug as a temporary measure, pending the conclusion of an ongoing review of the medicine.

Alemtuzumab is a monoclonal antibody against CD52 that works by reducing circulating levels of T and B lymphocytes. It was authorised for use in adults with relapsing-remitting MS with active disease defined by clinical or imaging features in 2013.

The review follows reported cases of immune-mediated conditions, including autoimmune hepatitis and haemophagocytic lymphohistiocytosis; heart and blood vessel problems (including bleeding in the lungs, heart attack, stroke and cervicocephalic arterial dissection) occurring within one to three days of administration; and severe neutropenia. PRAC has recommended an update of alemtuzumab’s product information to inform patients and healthcare professionals of these cases.

The EMA states that alemtuzumab should only be started in adults with relapsing-remitting MS that is highly active despite an adequate course of treatment with at least two disease-modifying therapies, or when other disease-modifying therapies are contraindicated or unsuitable.

In patients being treated with alemtuzumab, vital signs should be monitored before and during intravenous infusion, and if clinically significant changes are observed, stopping the infusion and additional monitoring (including ECG) should be considered. In addition, liver function tests should be carried out before and during treatment. If the patient develops signs of liver damage, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction, the drug should only be re-administered after careful consideration.

Patients who develop signs of pathological immune activation (which may occur up to four years after the start of treatment) should be evaluated immediately and a diagnosis of haemophagocytic lymphohistiocytosis considered.


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