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EMA restrict use of multiple sclerosis medicine Lemtrada

Lemtrada, for Multiple sclerosis from Genzyme Therapeutics

The European Medicines Agency (EMA) has started a review of Genzyme's multiple sclerosis medicine alemtuzumab, brand name Lemtrada, following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Information for Patients
New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.

You should get medical help immediately if you experience symptoms of:
  • acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
  • bleeding in lungs: such as trouble breathing and coughing up blood
  • stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
  • liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
  • an inflammatory condition known as haemophagocytic lymphohistiocytosis: with symptoms of fever, swollen glands, bruising and skin rash

If you have any of these symptoms, contact your doctor who will examine you and may consider stopping Lemtrada and switching you to an alternative treatment.

An in-depth review of Lemtrada is ongoing and further information will be provided as soon as it is available.

While the review is ongoing, Lemtrada will only be prescribed to new patients if other medicines have not worked or are not suitable.

Speak with your doctor if you have questions or concerns about your treatment.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Further information
  • Doctors are being informed in writing of temporary restrictions on the prescription of Lemtrada pending the conclusion of an ongoing review of the medicine and inclusion of new safety warnings in the product information of Lemtrada.
  • New treatment should only be initiated in adults with relapsing-remitting multiple sclerosis that is highly active despite a full and adequate course of treatment with at least two other disease modifying therapies, or in adults with highly active relapsing-remitting multiple sclerosis where all other disease-modifying therapies are contraindicated or otherwise unsuitable
  • For patients being treated with Lemtrada, vital signs should be monitored before and during the intravenous infusion. If clinically significant changes are observed, discontinuation of infusion and additional monitoring, including ECG, should be considered
  • Liver function tests should be carried out before and during treatment. If patients develop signs of liver damage, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice or dark urine). Lemtrada should only be re-administered following careful consideration.
  • Patients who develop signs of pathological immune activation should be evaluated immediately, and a diagnosis of haemophagocytic lymphohistiocytosis considered. Symptoms of immune activation may occur up to 4 years after the start of treatment.
  • Further information will be provided once the review of Lemtrada is concluded.

About Lemtrada (source EMA)
Lemtrada is a medicine used to treat adults with relapsing-remitting multiple sclerosis, a disease of the nerves in which inflammation destroys 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 first made available in the EU in 2013. It is manufactured by Genzyme Therapeutics.

Sources
European Medicines Agency website page for Lemtrada
Accessed 16/04/19
Links available in full article

Link to EMA information on Lemtrada restriction

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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