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Anaphylaxis Warnings for Xolair

Posted on April 29, 2008

FDA has asked Genentech, the manufacturer of Xolair (omalizumab) to add a new boxed warning to the drug's labeling. This warning will emphasize that the product can cause anaphylaxis, sometimes with delayed onset.

Xolair, administered subcutaneously, is used to treat allergen-induced asthma in certain patients whose symptoms are not adequately controlled with inhaled steroids.

The strengthened warning includes the possibility that patients can develop anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose, and that anaphylaxis may be delayed up to 24 hours after the dose is given. Healthcare personnel should observe patients for at least two hours after an injection and be ready to manage anaphylaxis if it occurs.

Patients being treated with Xolair should be told about the signs and symptoms of anaphylaxis, how delayed anaphylaxis can occur, and how to treat it if it does occur. A Medication Guide with this information will be given to patients each time the drug is dispensed.

Additional Information:

FDA MedWatch Safety Alert. Xolair (omalizumab). February 21, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair

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