Prescribing information

 

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Xolair was the first biologic to receive a licence for the treatment of patients with severe allergic asthma (SAA).1,2  

Use the interactive widget below to discover the journey of Xolair from 2005 through to the present day, which has seen over 1.3 million patient treatment years of exposure in the real world.†2 Along the way, click on the ‘Did you know’ links to find out some short facts about Xolair that you may not know.

 

Indication:23
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.

Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.23

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.24
Exposure in patients with SAA and in patients with chronic spontaneous urticaria.2
Please refer to the SMC website for the full SMC guidelines for Xolair.

FEV, forced expiratory volume; GETE, global evaluation of treatment effectiveness; IgE, immunoglobulin E; INC, intranasal corticosteroids; NICE, National Institute for Health and Care Excellence; PEF, peak expiratory flow; RCT, randomised controlled trial; SMC, Scottish Medicines Consortium; SAA, severe allergic asthma.

 

References:

  1. European Medicines Agency Xolair Scientific Discussion. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/xolair-epar.... (Accessed: October 2021).
  2. Bousquet J et al. J Allergy Clin Immunol Pract 2021;9(7):2702–2714.
  3. Humbert M et al. Allergy 2005;60(3):309–316.
  4. Pharmafield (2006). Innovation rewarded at Prix Galien 2006. Available at: https://pharmafield.co.uk/in_depth/innovation-rewarded-at-prix-galien-2006/. (Accessed October 2021).
  5. Scottish Medicines Consortium (2007). Omalizumab 150mg powder and solvent for injection (Xolair®). Available at: https://www.scottishmedicines.org.uk/media/2079/259_06_omalizumab_xolair.... (Accessed October 2021).
  6. NICE (2007). Omalizumab for severe persistent allergic asthma. Available at: https://www.respiratoryfutures.org.uk/media/1028/ta133-guidance.pdf. (Accessed October 2021).
  7. Brusselle G et al. Respir Med 2009;103(11):1633–1642.
  8. EMEA (2009). Committee for medicinal products for human use post-authorisation summary of positive opinion for XOLAIR. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summ.... (Accessed October 2021).
  9. Kulus M et al. Curr Med Res Opin 2010;26(6):1285–1293.
  10. SMC (2010). Omalizumab 150 mg powder and solvent for solution for injection (Xolair®) (No: 611/10). Available at: https://www.scottishmedicines.org.uk/media/2078/omalizumabxolair_abbrevi.... (Accessed: October 2021).
  11. Bousquet J, et al. Allergy 2011;66(5):671–678.
  12. Hanania NA et al. Ann Intern Med 2011;154(9):573–582.
  13. Tzortzaki E et al. Pulm Pharmacol Ther 2012;25:77–82.
  14. Deschildre A et al. Eur Respir J 2013;42:1224–1233.
  15. Barnes N et al. J Asthma 2013;50(5):529–536.
  16. NICE (2013). Omalizumab for treating severe persistent allergic asthma. Technology appraisal guidance 278. Available at: https://www.nice.org.uk/guidance/ta278/resources/omalizumab-for-treating... (Accessed October 2021).
  17. Long A et al. J Allergy Clin Immunol 2014;134:560–567.
  18. Niven RM et al. BMJ Open 2016;6:e011857.
  19. Humbert M et al. Eur Respir J 2018;51:1702523.
  20. Novartis (2018). Novartis receives European Commission approval for self-administration of Xolair® across all indications. Available at: https://www.novartis.com/news/media-releases/novartis-receives-european-.... (Accessed October 2021).
  21. Namazy JA et al. Allergy Clin Immunol 2020;145:528–536.
  22. Novartis (2020). Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps. Available at: https://www.novartis.com/news/media-releases/novartis-receives-ec-approv.... (Accessed October 2021).
  23. Xolair® (omalizumab) Summary of Product Characteristics.
  24. Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.   
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UK | October 2021 | 161074
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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