Bilastine is a second-generation antihistamine employed for treating allergic rhinoconjunctivitis and urticaria in adults and children aged ≥6 years. The present study extracted the pharmacokinetic data for children aged 6 to 11 years from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received bilastine 10 mg/day orally. It compared the maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) data with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). It also extracted the safety data for children aged 6 to 11 years from a phase III randomized controlled trial in which children (aged 2-11 years) with allergic rhinoconjunctivitis or chronic urticaria received once-daily bilastine 10 mg or placebo for 12 weeks. 

The study observed:

• Similar exposure and C_max values for children (6-11 years) and adults, with median pediatric/adult ratios for AUC_0-24 and C_max as 0.93 and 0.91, respectively.
• No significant difference in the incidence of treatment-emergent adverse in children (6-11 years) who received bilastine 10 mg or placebo.

This pharmacokinetic and safety analysis, conducted in children aged 6 to 11 years, supports the suitability of the pediatric dose of bilastine 10 mg and confirms the comparable safety profiles between bilastine and placebo.

Source: Rodríguez M, Vozmediano V, García-Bea A, et al. Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria. Eur J Pediatr. 2020;179(5):801-5.