Health Canada announces that new safety information from post-market use of LEMTRADA (alemtuzumab) has been reported and includes fatal cases, cardiovascular adverse events that have occurred shortly after LEMTRADA infusions, and immune-mediated adverse reactions. The LEMTRADA Canadian Product Monograph has been updated to include a revised indication for use and safety information.
LEMTRADA is indicated for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with highly active disease defined by clinical and imaging features, despite an adequate course of treatment with at least two other disease modifying treatments (DMTs), or where any other DMT is contraindicated or otherwise unsuitable. Previously, LEMTRADA was indicated for the management of adult patients with RRMS, with highly active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.
This revised indication was implemented in light of new safety information identified from post-market use with LEMTRADA, including life-threatening and fatal cases reported in patients with RRMS receiving LEMTRADA. This includes reports of autoimmune hepatitis and haemophagocytic lymphohistiocytosis, as well as temporally associated serious cardiovascular reactions.
Patients receiving LEMTRADA should immediately speak with their healthcare professional if they experience any of the following conditions and associated symptoms:
- Liver inflammation: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
- An inflammatory condition known as hemophagocytic lymphohistiocytosis: fever, swollen glands, bruising and skin rash
- Heart problems: trouble breathing and chest pain
- Stroke or tears in the arteries of the head and neck: drooping of parts of the face, weakness on one side of the body, difficulty with speech, sudden severe headache, and neck pain
- Bleeding in lungs: trouble breathing and coughing blood
Healthcare professionals are advised to:
- Evaluate serum transaminases (ALT and AST) and total bilirubin levels before starting treatment and periodically for 48 months after the last LEMTRADA dose.
- Interrupt or stop treatment with LEMTRADA and promptly measure ALT, AST and total bilirubin in patients who develop clinical signs of hepatic dysfunction, including unexplained liver enzyme elevations or symptoms of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
- Immediately evaluate patients who develop disease manifestations of pathologic immune activation and consider a diagnosis of haemophagocytic lymphohistiocytosis.
- Monitor vital signs, including blood pressure, before and during LEMTRADA infusion. If clinically significant changes in vital functions are observed, discontinue the infusion, continue monitoring patient’s vital signs, including ECG, and consider appropriate interventions.
- Inform patients about the signs and symptoms of these temporally associated serious cardiovascular reactions, and advise them to seek immediate medical attention if any of these symptoms occur following infusion.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71299a-eng.php
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 autoimmune hepatitis, 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 28 Jun 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/Wednesday, Oct 16, 2019
Issued at HKT 16:00
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