The 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. In the same EXPECT study, 154 infants who had been exposed to Xolair through breast-feeding did not indicate adverse effects on the breast-fed infant. SPC advises that given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breast-fed newborns/infants are therefore anticipated. SPC also advises that 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.