Allergic reactions: As with any protein, local or systemic allergic reactions, including anaphylaxis, may occur when taking omalizumab. Therefore medications for the treatment of anaphylactic reactions should 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. Anaphylactic reactions were rare in clinical trials (see ADVERSE REACTIONS).
In post-marketing experience, anaphylaxis and anaphylactoid reactions have been reported following the first or subsequent administrations of Xolair. Most of these reactions occurred within 2 hours.
As with all recombinant DNA derived humanized monoclonal antibodies patients may in rare cases develop antibodies to omalizumab (see ADVERSE REACTIONS).
Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have rarely been seen in patients treated with humanized monoclonal antibodies including omalizumab. The onset has typically been 1 to 5 days after administration of the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgia, 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.
Parasitic infections: IgE may be involved in the immunological response to some infections. In patients at chronic high risk of helminth infection, a placebo-controlled trial in allergic asthma 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 program, 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 traveling to areas where helminthic infections are endemic. If patients do not respond to the recommended anti-helminth treatment, discontinuation of Xolair should be considered.
General: Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions.
Xolair has not been adequately studied in atopic dermatitis, allergic rhinitis or food allergy.
Xolair therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or those with pre-existing renal or hepatic impairment. Caution should be exercised when administering Xolair in these patient populations.
Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy in allergic asthma or nasal polyps is not recommended. Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Advice to handler: For subcutaneous administration only. Do not administer by the intravenous or intramuscular route.