Prescribing information

 

Information about the impact of Xolair on pregnancy, breast-feeding and fertility.

Heading. Pregnancy
 
If clinically needed, the use of Xolair may be considered during pregnancy.
  • A moderate amount of data on pregnant women (between 300–1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity
  • A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to Xolair showed the prevalence of major congenital anomalies was similar (8.1% vs 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients     
    • The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design
  • Care should be taken when prescribing in pregnancy as medicines can cross the placenta and may affect the foetus

 

Heading. Breast-feeding
 
If clinically needed, the use of Xolair may be considered in breast-feeding.
  • Immunoglobulins G are present in human milk and it is therefore expected that Xolair will be present in human milk. Available data in non-human primates have shown excretion of Xolair into milk
  • Data from the EXPECT study including 154 infants who had been exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects in the breast-fed infant     
    • The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design
  • Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breast-fed newborns/infants are anticipated

 

Heading. Breast-feeding
 
There are no human fertility data for Xolair
  • In specifically-designed non-clinical fertility studies in non-human primates, including mating studies, no impairment of male or female fertility was observed following repeated dosing with Xolair up to 75 mg/kg
  • No genotoxic effects were observed in a separate non-clinical genotoxicity study

 

 

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.2

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. 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 pharmacovigilance intake (PVI) tool at http://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]