Prescribing information

 

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

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If clinically needed, the use of Xolair may be considered during pregnancy.
 
  • A moderate amount of data on pregnant women (between 300 and 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

 

 
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

 

 
  • 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

 

Indication: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.1

Reference

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
XSU20-C012 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]