Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

[Guest guest]

I understand that there is a study being performed in various parts of the USA including Scripps and Cleveland Clinic.

Three questions:

Any of our group involved in these clinical trialsAnybody being injected with XolairAnybody familiar with what Xolair doesThanks

Any of our g

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[Guest guest]

Yes. I have Samter's and have been receiving xolair injections for the past 6 months. They have really improve my asthma. I recently had my second sinus surgery and that seems to have settled in my eyes -- they are red and I have headaches across them; I still have drainage/coughing. But that seems like a small price to pay to be able to breathe! Regina ChartacJS@... wrote: I understand that there is a study

being performed in various parts of the USA including Scripps and Cleveland Clinic.Three questions: Any of our group involved in these clinical trials Anybody being injected with Xolair Anybody familiar with what Xolair doesThanks Any of our g More new features than ever. Check out the new AOL Mail!

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see below... FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA FDA News FOR IMMEDIATE RELEASEP07-25February 21, 2007 Media Inquiries: Rawlings, 301-827-6242Consumer Inquiries: 888-INFO-FDA FDA Proposes to Strengthen Label Warning for Xolair Today the Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair. The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching

and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis. Xolair was approved in 2003 to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen (pollen, grass or dust) and whose symptoms are inadequately controlled with inhaled steroids. In clinical trials, Xolair decreased the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of baseline inhaled corticosteroid dose. Anaphylaxis was reported following administration of Xolair in clinical trials and was therefore, discussed in the initial product labeling. The cases were reported at a frequency of approximately one in a thousand patients (0.1%). 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, FDA has now requested that Genentech, Inc., add the boxed warning and strengthen the existing warning. As the agency gains experience and collects data about a marketed product the determination may be made to strengthen the product label to ensure that consumers are aware of newly identified significant risks. The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, 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

also carry and know how to initiate emergency self-treatment for anaphylaxis. For further information and a copy of the health care professional sheet, go to http://www.fda.gov/cder/drug/infopage/omalizumab/default.htm. #### RSS Feed for FDA News Releases [what's this?] Get free weekly updates about FDA press releases, recalls, speeches, testimony and more. FDA Newsroom FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility FDA Website Management Staff

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