Dosing and administration: Observation

Patients should be observed following administration of Xolair®

CSU

In more than 700 Xolair®-treated patients enrolled in the phase III trials there were no cases of Xolair®-related anaphylaxis.1-3

Asthma

In patients with severe allergic asthma, anaphylaxis was rare (≥1/10,000 to <1/1,000) in previous clinical trials. Onset was usually within 2 hours of the first or subsequent injections, but may occur later. Patients should be informed that such reactions are possible.4

Model is a hypothetical patient profile, for illustrative purposes only

Xolair® 300mg vs. baseline at 12 weeks; p<0.001 vs placebo.

*Data from ASTERIA II; two other phase III studies (ASTERIA I and GLACIAL) were also conducted to assess efficacy and safety of Xolair® in inadequately controlled CSU patients

References: 1. Maurer M, et al. N Engl J Med 2013; 368(10):924-935. 2. Kaplan A, et al. J Allergy Clin Immunol 2013; 132(1):101-9. 3. Saini SS, et al. J Invest Dermatol 2014 [Epub ahead of print]. 4. Xolair® Summary of Product Characteristics 2016

NP4 code: GLDEIM/IGE025E/0181

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