Other safety alerts
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| European Union: Lemtrada for multiple sclerosis: measures to minimise risk of serious side effects |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis. The recommendations reflect PRAC’s review of reports concerning rare but serious effects, including deaths, from immune-mediated conditions (caused by the body’s defence system not working properly) and serious heart, circulation and bleeding disorders, including stroke. Immune-mediated conditions can occur many months after treatment while serious disorders of the heart, circulation and bleeding may develop within days of receiving Lemtrada.
The PRAC has recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage. Also, Lemtrada must no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.
New measures have been recommended for identifying and promptly dealing with adverse effects that might occur after treatment with Lemtrada. It should be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.
The PRAC has also recommended updating the physician’s guide and the patient information pack with advice to minimise the risk of serious heart, circulation and bleeding disorders that may occur shortly after the infusion (drip) as well as autoimmune conditions that could occur many months after the last Lemtrada treatment.
The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/documents/../lemtrada-article-20-procedure-lemtrada-multiple-sclerosis-measures-minimise-risk-serious-side_en.pdf
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 16 Oct 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/Friday, Nov 1, 2019
Issued at HKT 15:00
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