European Medicines Agency (EMA) is recommending restriction of the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects are also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well as stroke) and immune-related disorders (caused by the body’s defence system not working properly).
Lemtrada should now only be used to treat relapsing-remitting multiple sclerosis if the disease is highly active despite treatment with at least one disease-modifying therapy or if the disease is worsening rapidly. Lemtrada must also no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have autoimmune disorders other than multiple sclerosis.
The medicine should only be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.
EMA has also recommended updating the physician’s guide and the patient information pack with advice on minimising the risk of serious cardiovascular disorders, which may occur shortly after a Lemtrada infusion (drip), and immune-related conditions, which may occur many months and possibly years after the last treatment.
These recommendations were issued by EMA’s safety committee (PRAC) and have now been endorsed by EMA’s human medicines committee (CHMP). They will replace the temporary measures introduced in April 2019 while the review of Lemtrada was under way. The changes come into force when the European Commission issues its decision.
Information for patients
• 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.
Information for healthcare professionals
• 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/documents/../measures-minimise-risk-serious-side-effects-multiple-sclerosis-medicine-lemtrada_en.pdf
Local Situation in Hong Kong: In Hong Kong, Lemtrada Concentrate For Solution For Infusion 12mg/1.2ml (HK-64543) is a registered pharmaceutical product containing alemtuzumab. The product is registered by Sanofi-Aventis Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to alemtuzumab, but these cases are not related to immune-mediated conditions such as autoimmune hepatitis and haemophagocytic lymphohistiocytosis, or serious cardiovascular reactions.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 30 Nov 2018, with the latest update posted on 1 Nov 2019. Letters to inform local healthcare professionals were issued by the DH on 30 Nov 2018 and 15 Apr 2019.
In Sep 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of the product should include safety information about immune-mediated conditions and problems with the heart and blood vessels. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/ Saturday, November 16, 2019
Issued at HKT 12:00
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