<p>Xolair is used to improve the control of severe persistent asthma caused by an allergy. It is used as an add-on to asthma treatment in patients from 6 years of age when an antibody called immunoglobulin E (IgE) causes the asthma. Xolair must only be used in patients who:</p><ul><li>have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;</li><li>have frequent symptoms during the day or waking up during the night;</li><li>have had many severe asthma attacks (that require rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.</li></ul><p>In patients aged 12 years or over, Xolair must only be used if the lung function is less than 80% of normal.</p><p>Xolair is also used to treat:</p><ul><li>chronic (long-term) spontaneous urticaria (itchy rash). It is used as an add-on to existing treatment in patients aged 12 years or over in whom treatment with an antihistamine does not work well enough;</li><li>severe chronic rhinosinusitis with nasal polyps (inflamed lining of the nose and sinuses with swellings in the nose) in adults. It is used with a corticosteroid given into the nose when the corticosteroid alone does not work well enough.</li></ul><p>Xolair contains the active substance omalizumab.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p><strong>Allergic asthma</strong></p><p>Xolair is indicated in adults, adolescents and children (6 to <12 years of age).</p><p>Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.</p><p><em>Adults and adolescents (12 years of age and older)</em></p><p>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 <em>in vitro</em> 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.</p><p><em>Children (6 to <12 years of age)</em></p><p>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 <em>in vitro</em> 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.</p><p><strong>Chronic rhinosinusitis with nasal polyps (CRSwNP)</strong></p><p>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.</p><p><strong>Chronic spontaneous urticaria (CSU)</strong></p><p>Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.</p></div>
Therapeutic Area (MeSH)
ATC Code
R03DX05
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for obstructive airway diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| omalizumab | N/A | omalizumab |
EMA Name
Xolair
Medicine Name
Xolair
Aliases
N/ANo risk management plan link.
