Safety: Warnings and precautions

Special warning and precautions
for use2

  • Anaphylactic reactions and other allergic reactions: Frequency rare. Most of these reactions occurred within 2 hours after the first and subsequent injections of Xolair® but some started beyond 2 hours and even beyond 24 hours after the injection. Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair®. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
  • Serum sickness and serum sickness-like reactions: Frequency rare. The onset has typically been 1‑5 days after administration of the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.
  • In patients at chronic high risk of helminth infection, a placebo-controlled trial in allergic patients showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered. The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients. However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic. If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair® should be considered.
  • The removable needle cap of the pre-filled syringe contains a derivative of natural rubber latex. Although, no natural rubber latex has to date been detected in the removable needle cap, its use in latex-sensitive individuals has not been studied and thus a potential for hypersensitivity reactions cannot be completely ruled out.

Model is a hypothetical patient profile, for illustrative purposes only

*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

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

Xolair® is also available as a lyophilized formulation

References: 1. Maurer M, et al. N Engl J Med 2013;368:924-935. 2. Xolair® Summary of Product Characteristics 2016. 3. Maurer M et al. Allergy 2011;66:317-330. 4. Weller K, et al. J Eur Acad Dermatol Venereol 2013;27:43-50

NP4 code: GLDEIM/IGE025E/0181

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