Xolair Solution for Injection Pre-Filled Syringe

Each pre-filled syringe contains 300 mg of omalizumab* in 2 ml solution.

*Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology.

Xolair (Omalizumab) 300mg Solution for Injection in Pre-Filled Syringe 1 x 2ml is indicated for:

Allergic asthma:

Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

Adults and adolescents (12 years of age and older):

Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to <12 years of age):

Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Chronic rhinosinusitis with nasal polyps (CRSwNP):

Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control.

Available on request.

Available on request.