Other safety alerts
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| Canada: EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of prophylaxis or treatment failure due to antiviral resistance |
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Health Canada announces that Evusheld (tixagevimab and cilgavimab for injection) may not be effective against certain SARS-CoV-2 Omicron subvariants when used as a prophylaxis or treatment for COVID-19.
Healthcare professionals are advised to:
• Consider local epidemiology and individual exposure to circulating SARS-CoV-2 viral variants when making decisions regarding the use of Evusheld.
• Inform patients who receive Evusheld about the potential for a lack of effectiveness against certain SARS-CoV-2 viral variants. Instruct patients to seek medical advice if signs or symptoms of COVID-19 occur, persist or worsen.
• Refer to the Evusheld Canadian Product Monograph (CPM), in conjunction with the literature and local guidelines, for information regarding specific variants and antiviral resistance.
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, such as Evusheld. The CPM for Evusheld has been updated to include new information about the risk of prophylaxis or treatment failure due to antiviral resistance, including neutralization data on SARS-CoV-2 Omicron subvariants.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/evusheld-tixagevimab-and-cilgavimab-injection-risk-prophylaxis-or-treatment-failure
In Hong Kong, Evusheld Solution For Injection 150mg/1.5mL + 150mg/1.5mL (HK- 67457) is a pharmaceutical product registered by Astrazeneca Hong Kong Ltd. The product is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Evusheld. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Oct 27, 2022
Issued at HKT 16:00
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