Icatibant may be safe and effective for the treatment of acute hereditary angioedema (HAE) attacks in children, according to a study published in The Journal of Dermatology.

In this open-label, phase 3 study conducted in Japan, the researchers evaluated the safety, efficacy, and pharmacokinetics of icatibant in 2 pediatric patients aged 10 to 13 and 6 to 9 years. The patients experienced a total of 4 acute HAE attacks for the study duration and each time received a single dose of subcutaneous weight-adjusted icatibant within 12 hours of abdominal and/or cutaneous symptom onset.

The researchers investigated the following dosing regimen: 12 to 25 kg = 10 mg, 26 to 40 kg = 15 mg, 41 to 50 kg = 20 mg, 51 to 65 kg = 25 mg, and more than 65 kg = 30 mg.

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According to the study protocol, patients could receive up to 2 additional injections of icatibant if the achieved symptom relief was not sufficient, 6 hours apart, and within 48 hours of the initial dose. Moreover, the patients could receive subsequent icatibant treatment for up to 2 additional acute HAE attacks.

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According to the results, the patients reported relief from symptoms in 0.9 to 1.0 h upon icatibant administration. The medication was quickly absorbed and caused only mild or moderate injection-site adverse reactions.

“To date, several therapies to treat acute HAE attacks in pediatric patients have been developed; however, there are no approved pediatric treatments for acute HAE attacks in Japan,” Hide and colleagues noted.

The clinical symptoms of HAE usually present during childhood or adolescence, with attacks becoming more severe at puberty. Children often experience subcutaneous edema as the earliest symptom, followed by potentially fatal upper airway edema that can quickly progress to asphyxia.


Hide M, Wang Y, Dote N, Miyakawa K, Sugiura K, Ishida K. Safety, efficacy, and pharmacokinetics of icatibant treatment in Japanese pediatric patients with hereditary angioedema: a phase 3, open-label study. J Dermatol. Published online June 29, 2023. doi:10.1111/1346-8138.16883