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Title: Temsirolimus Associated With Hypersensitivity/Infusion Reactions, Warns Health Canada
URL: http://www.pslgroup.com/dg/228196.htm
Doctor's Guide
August 12, 2008

ONTARIO -- August 11, 2008 -- Health Canada is advising healthcare professionals regarding new safety information concerning the timing of, and monitoring for, hypersensitivity/infusion reactions associated with the administration of temsirolimus (Torisel).

As of April 3, 2008, 46 medically confirmed reports (30 spontaneous reports) of hypersensitivity/infusion reactions of variable severity, including 6 life-threatening and 1 fatal reaction, have been reported worldwide.

Other related adverse events including but not limited to flushing, chest pain, dyspnea, hypotension, apnea, and loss of consciousness in association with the intravenous administration of temsirolimus 25 mg have been reported.

Of 39 reports in which dose-time was reported, the majority (25) occurred with the first dose, often within the first few minutes of the infusion, although hypersensitivity reactions have also been reported associated with subsequent infusions.

A temsirolimus infusion should be interrupted in all patients with severe infusion reaction and appropriate medical care administered. A benefit-risk assessment should be done prior to the continuation of temsirolimus therapy in patients with severe or life-threatening reactions. Emergency supportive care should be readily available.

It is recommended that patients be premedicated with a selective H1-receptor antagonist before the start of intravenous temsirolimus infusion.

Temsiroimus should be used with caution in patients with known hypersensitivity to an antihistamine or in those who cannot receive an antihistamine for other medical reasons.

The Warnings and Precautions section of temsirolimus has been updated in consultation with Health Canada with respect to this safety information.

Any suspected adverse reaction can also be reported to: Canada Vigilance Program, Marketed Health Products Directorate, HEALTH CANADA, Address Locator: 0701C
Ottawa, Ontario, K1A 0K9 Tel: 613-957-0337 or Fax: 613-957-0335.


SOURCE: Health Canada

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