Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6–11 years were extracted post hoc from a study in which children (2–11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (C(max)) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6–11 years were extracted post hoc from a phase III randomized controlled trial of children (2–11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and C(max) values were similar for children (6–11 years) and adults: median pediatric/adult ratios for AUC(0–24) and C(max) were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6–11 years) receiving bilastine 10 mg or placebo. Conclusion: Pharmacokinetic and safety analyses in children aged 6–11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar.