Xolair Update- 2008
Friday, January 18, 2008 at 02:25PM Last year the FDA (Food and Drug Administration) made recommendations to the makers of Xolair (Omalizumab) regarding risks of anaphylaxis (severe allergic reaction). Warning labels have been formed by Novartis and Genentech in response to the FDA bulletin.
In short:
1) Patients on Xolair injection therapy should be aware that there is a risk of having a severe allergic reaction.
2) The FDA recommends an initial waiting period of 2 hours. How long you should wait after the initial shots depends on the advisory of the physician in charge.
3) Xolair injections should only be given in settings where anaphylaxis may be treated with appropriate medications and by staff skilled in recognizing and treating anaphylaxis.
4) Clinical trials revealed that anaphylaxis may occur more than 24 hours after injection, and after any injection. For this reason it is recommended that all patients on Xolair have a means of self injecting epinephrine (Epi-Pen or Twinject).
5) There was a 0.1% incidence of anaphylaxis observed in approximately 40,000 patients on Xolair across the nation. This relates to about a one in one thousand chance of having a potentially severe allergic reaction. There were no deaths reported in the analysis.
Bottom Line:
Xolair therapy continues to be a welcomed addition to the treatment options for people 12 years or older with moderate to severe asthma, that are not adequately controlled on low to medium dose inhaled steroids. Candidates for Xolair therapy must be allergic to at least one perennial allergen and have a certain level of IgE antibody in their blood.
Experience has shown that Xolair may significantly reduce asthma symptoms, asthma attacks and the need for high dose inhaled and oral steroids.
A more comprehensive review of Xolair and links to other sites may be found on an earlier posting (Xolair: for some patients with difficult to control asthma- June 10th, 2007)
