Lemtrada

• Serious but rare side effects have been reported with Lemtrada, including disorders of the heart, blood vessels and problems of the immune system which may affect blood and organs such as the lungs and liver.
• Your doctor will review your treatment to check if treatment with Lemtrada remains appropriate.
• You will be watched closely in hospital when you receive Lemtrada and for a short period afterwards, but some side effects can develop days or months later. You must get medical help immediately if:
  • you have any chest pain or breathing difficulty while Lemtrada is being given to you or in the next few days (signs of heart problem);
  • you cough up blood or have breathing difficulty (signs of bleeding in the lungs);
  • you have drooping of the face, severe headache, neck pain, weakness on one side or difficulty speaking (signs of stroke or damage to blood vessels in your brain);
  • your skin or eyes turn yellow, or you have dark urine, pain in your belly or you bleed or bruise easily (signs of liver damage);
  • you have fever, swollen glands, bruising or rash (signs of a dangerous immune disorder called haemophagocytic lymphohistiocytosis).
• Carefully read the updated Lemtrada patient guide and patient alert card because they contain important information and reminders about what to watch out for.
• Speak with your doctor or pharmacist if you have any questions or concerns about your treatment.

• Rare but serious effects that can occur within 1 to 3 days of Lemtrada infusion include myocardial ischaemia, myocardial infarction, cerebral haemorrhage, cervicocephalic arterial dissection, pulmonary alveolar haemorrhage and thrombocytopenia.
• Autoimmune side effects occurring within 48 months or longer after the last dose of Lemtrada include autoimmune hepatitis and haemophilia A as well as immune thrombocytopenic purpura, thyroid disorders and, rarely, nephropathies. Haemophagocytic lymphohistiocytosis, a syndrome of immune activation characterised by fever, hepatomegaly and cytopenia, has also been reported.
• Serious infections as well as reactivation of Epstein-Barr virus can also occur.
• Lemtrada should now only be used as a single disease-modifying therapy in adults with relapsing remitting multiple sclerosis with:
  • highly active disease despite a full and adequate course of treatment with at least one disease-modifying therapy or
  • rapidly evolving severe disease 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 compared to a recent MRI.
• In addition to current contraindications, Lemtrada is now also contraindicated in:
  • severe active infections until complete resolution
  • uncontrolled hypertension
  • history of angina pectoris, myocardial infarction, stroke or dissection of the cervicocephalic arteries
  • coagulopathy, on antiplatelet or on anti-coagulant therapy
  • concomitant autoimmune diseases other than multiple sclerosis
• Patients should receive Lemtrada only in a hospital with ready access to intensive care and with specialists and equipment for diagnosing and managing cardiac and cerebrovascular reactions and cytokine release syndrome, as well as autoimmune disorders and infections.
• The summary of product characteristics includes updated information on monitoring for side effects, including instructions on evaluations before, during and after Lemtrada infusion.
• The guide for healthcare professionals will also be updated.
• The patient should be provided with the Lemtrada patient guide and patient alert card and be advised to seek medical help immediately if any signs of serious side effects occur.

Lemtrada is a medicine used to treat adults with relapsing-remitting multiple sclerosis, a disease of the nerves in which the body’s immune system acts incorrectly to destroy the protective sheath surrounding the nerve cells. Relapsing-remitting means that the patient has attacks (relapses) in between periods with few or no symptoms (remissions). The medicine is used for patients with active disease. It is given by infusion (drip) into a vein.

The active substance in Lemtrada, alemtuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called CD52 found on white blood cells of the immune system (the body’s defences). By attaching to CD52, alemtuzumab causes the white blood cells to die and be replaced, thereby reducing damaging activity of the immune system.
 
Lemtrada was authorised in the EU in 2013. More information about the medicine is available on the EMA website: Lemtrada.

The review of Lemtrada was initiated on 10 April 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. While the review was ongoing, the PRAC had issued temporary recommendations restricting the use of the medicine.

The PRAC issued its final recommendations on 31 October to replace the temporary measures. The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 16 January 2020, which is applicable in all EU Member States.