EMA restrict use of multiple sclerosis medicine Lemtrada
Lemtrada, for Multiple sclerosis from Genzyme Therapeutics
- 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
- 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.
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.
Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.
Sharable Article Link : https://keepmeinformed.eu/Article?articleGuid=03a1d0e1-672f-43e8-8ce8-49d810547a1c