Data in 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

• 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

• 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.