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Stronger Warning Proposed for Xolair

The FDA announced in February 2007 that it has requested Genentech, Inc. add a boxed warning to the product label for Xolair (omalizumab), which is used to treat asthma related to allergies.

The boxed warning emphasizes that Xolair may cause anaphylaxis, a reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. Anaphylaxis was discussed in the initial product labeling for Xolair, which was approved in 2003. Due to the nature of continued reports in the post-marketing experience, including their life-threatening potential, frequency, and the possibility for the delayed onset of anaphylaxis, the FDA has now requested that Genentech, Inc., add a boxed warning and provide a medication guide for patients to strengthen the warning for anaphylaxis.

• Patients may develop anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose.
• Anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given.
• Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection.
• Following administration of Xolair, patients should carry and know how to initiate emergency self-treatment for anaphylaxis.

For more information, go to www.fda.gov/cder/drug/infopage/omalizumab/default.htm

Date Posted: April 17, 2007

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