Prescribing information

 

Key safety data for Xolair in SAA.

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Confidence

 

Preview of icon 1 with calendar showing that Xolair has been on the market in the EU since 2005

 

Xolair has been on the market in the EU since 20051

Preview of icon 2 with people standing around a globe showing that Xolair has more than 1.3 million patient years of experience globally.

 

1.3 million patient years of experience globally2

 

Preview of icon 3 with badge demonstraing that Xolair has an established safety profile including moderate amount of data in pregnancy.

 

An established safety profile including a moderate amount of data in pregnancy†1

 

Preview of icon 4 demonstrating that Xolair's shelf life has now extended to 18 months and can be kept for 48 hours at up to 25 degrees celsius.

 

Shelf life at 2–8°C now extended to 18 months, and can be kept for 48 hours at up to 25°C and returned to the refrigerator1

 

 

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
Preview of 'Did you know...' image stating that Xolair was launched in Europe in 2005 and has >1.3 million patient-years of market experience?2
 

 

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)
 

*In a pooled analysis across six studies in patients with severe allergic asthma, omalizumab (n=1,342) consistently improved quality of life, delivering significantly greater improvements in the asthma quality of life questionnaire (AQLQ) overall score compared with placebo/control (n= 1,206) [1.01 vs 0.61; p<0.001]; and in the proportion of patients in the pooled population recording a ≥0.5-point improvement in AQLQ overall score [66.3% omalizumab vs 52.4% placebo/control p<0.001].5
If clinically needed, the use of Xolair may be considered during pregnancy.
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. Chipps B, et al. Curr Med Res Opin 2006;22(11):2201–2208.
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UK | May 2022 | 210058
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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
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]