其 他 安 全 警 示
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| Association of Actemra (tocilizumab) with anaphylaxis |
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Roche Hong Kong Ltd has informed Department of Health about an overseas report of a post-marketing case of fatal anaphylaxis in a patient with rheumatoid arthritis. Actemra is an intravenous drug mainly used in combination with methotrexate for the treatment of moderate and severe active rheumatoid arthiritis. A 67-year old woman died of the anaphylactic event after the fifth infusion of Actrema. This is the first reported case of fatal anaphylaxis in a patient treated with Actrema. Clinically significant hypersensitivity reactions associated with Actrema and requiring treatment discontinuation have been reported in 0.3% of all patients receiving tocilizumab in clinical trials.
In Hong Kong, a “Dear Healthcare Professional” letter has been sent to healthcare professionals to remind them to exercise extra caution when prescribing and supplying this drug to their patients. If an anaphylactic or other serious hypersensitivity reaction occurs following administration of Actemra, administration of Actemra should be stopped immediately. Appropriate medical management should be initiated, and Actemra should be permanently discontinued.
Ends/Thursday, August 26, 2010
Issued at HKT 12:00
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