Safety, efficacy, and pharmacokinetics of icatibant treatment in Japanese pediatric patients with hereditary angioedema: A phase 3, open‐label study

Abstract

AbstractWe evaluated the safety, efficacy, and pharmacokinetics of subcutaneous weight‐adjusted icatibant for the treatment of acute hereditary angioedema attacks in Japanese pediatric patients. Two patients (aged 10–13 and 6–9 years) received icatibant for a total of four attacks. Each attack was abdominal and/or cutaneous and was treated with a single icatibant injection. Mild or moderate injection‐site reactions were the only adverse events reported. Time to onset of symptom relief was 0.9–1.0 h. Icatibant was rapidly absorbed, with a pharmacokinetic profile consistent with previous studies. Simulated exposure levels were consistent with non‐Japanese pediatric patients. These results support the safety and efficacy of icatibant in Japanese pediatric patients.