The Medical Letter on Drugs and Therapeutics
In Brief: Anaphylaxis with Omalizumab (Xolair)
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Med Lett Drugs Ther. 2007 Jul 16;49(1265):59
 Select a term to see related articles  2007   Anaphylaxis   Anaphyylaxis with omalizumab (xolair)   asthma   hypersensitivity reactions   In brief   issue 1265   July 26   monoclonal IgE antibody   omalizumab   page 60   volume 49   Xolair 

The FDA has received new reports of serious and life-threatening hypersensitivity reactions to omalizumab (Xolair – Genentech), a monoclonal anti-IgE antibody injected subcutaneously for treatment of asthma (Med Lett Drugs Ther 2003; 45:67), and has added a black-box warning to the package insert.

Postmarketing reports submitted to the FDA included 124 reports of anaphylaxis among an estimated 57,300 patients (0.2%) who might have been treated with the drug between June 2003 and December 2006. Anaphylaxis occurred after the first dose of Xolair in 39% of cases, after a 2nd dose in 19%, after a 3rd dose in 10% and after subsequent doses in the rest; one case occurred after 39 doses (19 months of continuous therapy) when treatment was restarted after a 3-month gap. Most cases (59%) occurred within 2 hours of the injection, but 32% occurred later, up to 4 days after the injection. No deaths have been reported (

Use of omalizumab should be limited to patients with severe asthma that is not adequately controlled by other drugs and has a clear allergic component. Patients should be observed for 2 hours after injection in a setting where anaphylaxis can be diagnosed and treated promptly and should carry an epinephrine autoinjector (EpiPen; Twinject) for a few days following an injection.

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