The European Medicines Agency (EMA) recommends not to start new treatments with LEMTRADA®. Treatment of new patients with LEMTRADA® (alemtuzumab) can only be initiated in adult patients with highly active relapsing-remitting multiple sclerosis (RRMS), despite complete and adequate treatment with at least two other disease-modifying therapies (DMT), or in adult patients with highly active RRMS for whom any other DMT is contraindicated or unsuitable.
Since the introduction of LEMTRADA® (alemtuzumab), new safety concerns have been reported related to the use of the drug in the treatment of multiple sclerosis. These concern serious cases (including fatal cases) of cardiovascular reactions, in close temporal association with LEMTRADA® infusions, and immune-mediated diseases (autoimmune hepatitis and hemophagocytic lymphohistiocytosis).
Further information on these cases is available in the Direct Healthcare Professional Communication (DHPC) sent by the company that markets LEMTRADA® (alemtuzumab).
Following these reports, the European Medicines Agency (EMA) initiated a reassessment of the benefits and risks of LEMTRADA® (alemtuzumab) on 11 April 2019.
Until the re-evaluation is finalised, the use of LEMTRADA® (alemtuzumab) is restricted. Only adult patients with highly active relapsing-remitting multiple sclerosis (RRMS), despite complete and adequate treatment with at least two other disease-modifying therapies (DMTs), or adult patients with highly active RRMS for whom any other DMT is contraindicated or unsuitable, may receive new treatment with LEMTRADA® (alemtuzumab). Furthermore, following measures have been agreed on:
- Vital signs of patients receiving alemtuzumab therapy, including blood pressure, should be monitored before and periodically during an alemtuzumab intravenous drip. If clinically significant changes in vital functions are observed, discontinuation of the intravenous drip and additional monitoring, including ECG, should be considered.
- Liver function should be assessed before and during treatment.
- In case of symptoms of liver damage or other severe immune-mediated reactions, treatment can only be re-administered after a thorough analysis of the patient’s state of health.
- Patients should be advised to consult a physician immediately if they develop symptoms within a few days of the intravenous drip or if they develop symptoms of liver damage.
Patients currently treated with LEMTRADA® and for whom treatment is beneficial, may continue treatment after consulting their prescribing physician.