Other safety alerts
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| The United Kingdom: Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that while an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.
An urgent EU-wide review of the safety of alemtuzumab for multiple sclerosis has begun following reports of immune-mediated reactions and serious cardiovascular events, particularly within 3 days of dosing. There have been some life-threatening and fatal cases. While the review is ongoing, the use of alemtuzumab for multiple sclerosis has been restricted and new monitoring requirements introduced. MHRA will update healthcare professionals once final recommendations are available.
Advice for healthcare professionals:
Restricted indication for new patients
• alemtuzumab for multiple sclerosis should only be started in adults with either:
o relapsing-remitting multiple sclerosis that is highly active despite an adequate course of treatment with at least 2 other disease-modifying therapies
o highly active relapsing-remitting multiple sclerosis if all other disease-modifying therapies are contraindicated or otherwise unsuitable
• patients already on alemtuzumab for multiple sclerosis may continue treatment if it is beneficial and they have discussed the additional monitoring requirements and new risks with their prescriber
New monitoring requirements and precautions for use
• monitor vital signs, including blood pressure, before and periodically during alemtuzumab infusion – consider stopping the infusion and conducting additional monitoring, including electrocardiography (ECG), if any clinically significant changes in vital signs occur
• monitor liver function tests before and during treatment with alemtuzumab for multiple sclerosis
• consider discontinuing treatment in patients who develop hepatic injury or serious immune-mediated reactions
• evaluate immediately any patients who develop early manifestations of pathologic immune activation, and consider a diagnosis of haemophagocytic lymphohistiocytosis (see below)
Advice to give to patients
• alert patients to the symptoms of:
o pulmonary haemorrhage, myocardial infarction, stroke, and arterial dissection within days of infusion – patients should seek urgent medical attention if they develop any symptoms of these disorders (see below), which may occur within a few days of treatment
o hepatic injury – patients should seek urgent medical help if they develop any symptoms of liver injury including abdominal pain, jaundice, dark urine, and unexplained nausea or vomiting
o haemophagocytic lymphohistiocytosis – patients should seek immediate medical attention if they develop unexplained fever, lymphadenopathy, bruising or rash, including if these symptoms occur several years after treatment
• patients should speak to their doctor if they have any questions about alemtuzumab for multiple sclerosis
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/lemtrada-alemtuzumab-and-serious-cardiovascular-and-immune-mediated-adverse-reactions-new-restrictions-to-use-and-strengthened-monitoring-requirements
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 2 cases of adverse drug reaction for alemtuzumab, with one case related to immune functions.
Related news on warning about rare but serious risks of stroke and blood vessel wall tears associated with Lemtrada (alemtuzumab) was released by the US Food and Drug Administration (FDA) and was posted on the Drug Office website on 30 November 2018. Letters to inform healthcare professionals for the warnings were issued on the same day; and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Related news on restricted use and strengthened monitoring requirements introduced for Lemtrada (alemtuzumab) was previously released by the EMA and was posted on the Drug Office website on 13 April 2019. Letters to inform healthcare professionals were issued on 15 April 2019. Since EMA’s review is on-going, DH will remain vigilant on the conclusion of the EMA review and any safety updates on alemtuzumab issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, May 18, 2019
Issued at HKT 17:00
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