METHODS: Pregnant women with HAE from the United States and Europe who received rhC1-INH were followed to full term and were assessed for adverse events (AEs) that occurred during pregnancy and neonatal outcomes.
RESULTS: Eight pregnant women (age, 21-33 years) with HAE treated with rhC1-INH were identified. Seven women were treated with rhC1-INH (2100 IU−4200 IU) for 1 (n=1), 2 (n=2), 6 (n=1), 8 (n=1), 9 (n=1), or 40 (n=1) HAE attacks; 10 laryngeal attacks occurred in 2 patients. One woman received 2 administrations of rhC1-INH 50 IU/kg as prophylaxis during a clinical trial. rhC1-INH was effective in all attacks with no additional rescue medications needed. There were no AEs considered related to rhC1-INH treatment during the pregnancy period. Of 4 women with birth delivery data, 3 had a vaginal delivery and 1 a cesarean without complications. All 8 women gave birth at full term to healthy babies. No fetal distress or congenital abnormalities were reported.
CONCLUSIONS: Treatment with rhC1-INH for HAE attacks in pregnant women was generally safe and well tolerated. Delivery at full term with the births of healthy babies occurred without complications.