Temsirolimus (Torisel ) is an antineoplastic agent used to treat patients with advanced renal-cell carcinoma who have at least three of six prognostic risk factors. Infusion-related hypersensitivity reactions have occurred during the administration of Temsirolimus. The reactions include, but are not limited to, flushing, chest pain, dyspnoea, hypotension, apnoea, loss of consciousness, and anaphylaxis.

Up to April 3, 2008, the marketing authorisation holder for Torisel had received 46 spontaneous reports of infusion-related hypersensitivity reactions, one of which had a fatal outcome.

In a pivotal clinical trial1 in renal-cell cancer, 18 ( 9% ) of 208 of patients treated with Temsirolimus experienced allergic reactions of any severity.
In all clinical trials to date, about 1% of patients treated with Temsirolimus have experienced serious hypersensitivity or infusion reactions.

Most reactions have occurred with the first infusion, commonly within the first few minutes of the start of the infusion; however, reactions with subsequent infusions have also been reported.
In some cases, the reactions occurred despite patients having received antihistamine premedication.

Source: Drug Safety Update – MHRA, 2009

XagenaMedicine2009


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