Prescribing information

 

Key safety data for Xolair in SAA.

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Confidence

 

Xolair has been on the market for 15 years in the EU1

1.3 million patient years of experience globally2

An established safety profile including data in pregnancy regardless1

 

Think confidence

 

Xolair has a well-characterised safety profile1–4

  • Safety has been evaluated in >16,000 patients receiving Xolair as part of a clinical trial programme2
  • Similar incidence of adverse events to placebo in the clinical trials3,4
  • Most reactions were mild or moderate in severity1
Bubble containing the words 'Did you know… Xolair has been launched in Europe for 15 years and has >1.3 million patient-years of market experience?1
 

 

List of adverse events reported with Xolair

Adverse events recorded in clinical studies in the total safety population treated with Xolair for allergic asthma1

 

Table showing adverse events reported with Xolair in adults and paediatric patients (children aged 6 to <12 years)
Table showing adverse events reported with Xolair in adults and paediatric patients (children aged 6 to <12 years)
 

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.5

Actual figure: 16,397.

 

Indication1: Xolair should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. In 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. In 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.

FEV1, forced expiratory volume in 1 second; IgE, immunoglobulin E; SAA, severe allergic asthma.

References

  1. Xolair® (omalizumab) Summary of Product Characteristics.
  2. Novartis data on file. Periodic Safety Update Report (PSUR) 2019.
  3. Kulus M et al. Curr Med Res Opin 2010;26(6):1285–1293.
  4. Humbert M et al. Allergy 2005;60(3):309–316.
  5.  Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.
XSA20-C016 July 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]