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Omalizumab (marketed as Xolair) Information
 FDA ALERT [2/2007, updated 7/2007]: This Alert highlights important revisions to the full prescribing information for Xolair. The updated full prescribing information for Xolair (July 2007) includes a new Boxed WARNING, updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS--Postmarketing Spontaneous Reports. A New Medication Guide [PDF] about the risk of anaphylaxis following administration of Xolair is to be distributed with each dose of Xolair. These revisions address the risk of anaphylaxis following treatment with Xolair. The implications of this new labeling for healthcare professionals who administer Xolair are summarized below. Xolair is approved to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available. Healthcare Professional Information
Other Information
Report Adverse Events to MedWatch
Date created: February 21, 2007; updated July 5, 2007 |
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