Overview

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:

  • 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;
  • have frequent symptoms during the day or waking up during the night;
  • 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.

In patients aged 12 years or over, Xolair must only be used if the lung function is less than 80% of normal.

Xolair is also used to treat:

  • 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;
  • 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.

Xolair contains the active substance omalizumab.

Xolair can only be obtained with a prescription and treatment should be started by a doctor who has experience of treating the condition for which it is to be used.

It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection. The powder and solvent form must be given by a doctor. The prefilled syringe may be used by the patient or caregiver following training and provided that the patient is not at high risk of a severe allergic reaction to the medicine.

The dose of Xolair and how often it is given depends on the condition being treated. For allergic asthma and chronic rhinosinusitis with nasal polyps, the dose is calculated on the basis of the patient's weight and levels of IgE in the blood.

For more information about using Xolair, see the package leaflet or contact your doctor or pharmacist.

The active substance in Xolair, omalizumab, is a monoclonal antibody, a type of protein, designed to attach to IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen. By attaching to IgE, omalizumab ‘mops up’ the free IgE in the blood. This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction. This helps to reduce the symptoms of allergy, such as asthma attacks. IgE is also involved in the inflammatory process, and reducing the amount of IgE shrinks nasal polyps and improves symptoms.

Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab may reduce inflammation and improve symptoms.

Allergic asthma

Xolair was studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one involving 482 patients with severe allergic asthma that was not controlled by conventional treatments. In all the studies, Xolair was compared with placebo (a dummy treatment), when added to the patients’ existing treatment. Xolair reduced the number of asthma attacks by around half. Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 asthma attacks per year in the Xolair group and around 1 per year in the placebo group. In addition, fewer of the patients receiving Xolair had asthma attacks than those receiving placebo. Patients treated with Xolair also reported greater improvement in quality of life (assessed using standard questionnaires) and used less fluticasone (a corticosteroid). The effects of Xolair were greater in patients with severe asthma.

In the study with patients with severe allergic asthma, there was no difference in the number of asthma attacks between Xolair and placebo, but Xolair led to a similar reduction in the number of asthma attacks as in previous studies.

In a study in 627 children with allergic asthma aged between 6 and 12 years, the number of asthma attacks was lower in those receiving Xolair. Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there were an average of 0.4 asthma attacks over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.

Chronic spontaneous urticaria

Xolair was investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment. In all the studies, Xolair was compared with placebo, when added to the patients’ existing treatment. The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity). After 12 weeks of treatment, Xolair 300 mg reduced itching by 4.5 to 5.8 points more than placebo. The effects were maintained after 6 months of treatment.

Chronic rhinosinusitis with nasal polyps

Two main studies involving a total of 265 patients showed a benefit from Xolair in chronic rhinosinusitis with nasal polyps not controlled well enough by corticosteroids given into the nose. All patients continued to receive treatment with mometasone (a corticosteroid) applied to the nose combined with either Xolair or placebo. The nasal polyp score (which can range from 0 to 8) improved by 0.99 points after 24 weeks in patients treated with Xolair compared with 0.13 points in patients receiving placebo. The nasal congestion score (which can range from 0 to 3) improved by 0.80 points in patients treated with Xolair compared with 0.28 points in patients receiving placebo.

The most common side effects with Xolair (which may affect up to 1 in 10 people) are headache and injection site reactions such as pain, swelling, redness and itching.

The most common side effects in children aged 6 to 12 years with allergic asthma include fever (very common) and upper abdominal (belly) pain.

In patients with chronic spontaneous urticaria the most common side effects also include joint pain, sinusitis and upper respiratory tract infections (nose and throat infections) while those in patients with chronic rhinosinusitis with nasal polyps also include upper abdominal pain, dizziness and joint pain.

For the full list of side effects and restrictions with Xolair, see the package leaflet.

The European Medicines Agency decided that Xolair’s benefits are greater than its risks and it can be authorised for use in the EU.

The Agency concluded that, overall, results from studies in allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps showed that Xolair was effective in reducing symptoms of the conditions, but the Agency noted that data on use beyond 6 months are limited for chronic spontaneous urticaria. The side effects of Xolair are manageable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xolair have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Xolair are continuously monitored. Side effects reported with Xolair are carefully evaluated and any necessary action taken to protect patients.

Xolair received a marketing authorisation valid throughout the EU on 25 October 2005.

Xolair : EPAR - Medicine overview

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Xolair : EPAR - Risk-management-plan summary

Product information

Xolair : EPAR - Product Information

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Latest procedure affecting product information: IAIN/0124/G

19/12/2023

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Xolair : EPAR - All authorised presentations

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Product details

Name of medicine
Xolair
Active substance
omalizumab
International non-proprietary name (INN) or common name
omalizumab
Therapeutic area (MeSH)
  • Asthma
  • Urticaria
Anatomical therapeutic chemical (ATC) code
R03DX05

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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.

Authorisation details

EMA product number
EMEA/H/C/000606
Marketing authorisation holder
Novartis Europharm Limited

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Opinion adopted
27/07/2005
Marketing authorisation issued
25/10/2005
Revision
49

Assessment history

Xolair : EPAR - Procedural steps taken and scientific information after authorisation

Xolair-H-C-000606-P46-074 : EPAR - Assessment report

Xolair-H-C-606-X-0115: EPAR - Assessment report - Extension

Xolair-H-C-606-P46-073 : EPAR - Assessment Report

Xolair-H-C-606-II-0101 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Xolair (II-101)

Xolair-H-C-606-P46-064 : EPAR - Assessment Report

Xolair-H-C-606-P46-063 : EPAR - Assessment Report

Xolair-H-C-606-P46-062 : EPAR - Assessment Report

Xolair-H-C-606-P46-069 : EPAR - Assessment Report

Xolair-H-C-606-P46-066 : EPAR - Assessment Report

Xolair-H-C-606-P46-061 : EPAR - Assessment Report

Xolair-H-C-606-P46-060 : EPAR - Assessment Report

Xolair-H-C-606-P46-059 : EPAR - Assessment Report

Xolair-H-C-606-P46-058 : EPAR - Assessment Report

Xolair-H-C-606-P46-057 : EPAR - Assessment Report

Xolair-H-C-606-P46-056 : EPAR - Assessment Report

Xolair-H-C-606-P46-0055 : EPAR - Assessment Report

Xolair-H-C-PSUSA-00002214-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Xolair-H-C-606-P46-054 : EPAR - Assessment Report

Keppra-H-C-606-P46-0051 : EPAR - Assessment Report

Xolair-H-C-606-P46-0047 : EPAR - Assessment report

Xolair-H-C-606-P46-0048 : EPAR - Assessment report

Xolair-H-C-606-P46-0049 : EPAR - Assessment report

Xolair-H-C-606-P46-0046 : EPAR - Assessment Report

Xolair-H-C-606-P46-0045 : EPAR - Assessment Report

Xolair-H-C-606-P46-0044 : EPAR - Assessment Report

Xolair-H-C-606-P46-039.2 : EPAR - Assessment Report

Xolair-H-C-606-II-0048 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Xolair

CHMP post-authorisation summary of positive opinion for Xolair on 25 June 2009

Xolair-H-C-606-II-0018 : EPAR - Assessment Report - Variation

Xolair : EPAR - Procedural steps taken before authorisation

Xolair : EPAR - Scientific Discussion

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