Pharmacokinetics and Safety of Bilastine 10 mg in Children Aged 6–11 Years
The second-generation antihistamine bilastine is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria from the age of 6 years. Recently, results from two post hoc analyses on the pharmacokinetics and safety of bilastine in children aged 6–11 years have been published.
Comparison of Bilastine Pharmacokinetics in Children (6–11 Years) and Adults
Pharmacokinetic data were obtained from a study conducted in children aged 2–11 years with allergic rhinoconjunctivitis or urticaria treated with oral bilastine at a dosage of 10 mg/day and from 7 studies in adults with a dosage of bilastine 20 mg/day. Samples were used from 24 children aged 6–11 years and from 126 adults.
The median area under the plasma concentration curve (AUC) was 1045 (standard deviation [SD] 381) ng×h/ml in children and 1121 (SD 387) ng×h/ml in adults (ratio 0.93). The median maximum plasma concentration (Cmax) was 212 (SD 123) ng/ml in children and 232.5 (SD 120) ng/ml in adults (ratio 0.91).
Safety of Bilastine in Children (6–11 Years) Compared to Placebo
For safety evaluation in children, data from a randomized controlled phase III study involving children aged 2–11 years with allergic rhinoconjunctivitis or urticaria who received oral bilastine 10 mg/day or placebo for 12 weeks were used. The population included 393 children with an average age of 8.5 years.
Treatment-related adverse events were reported in 5.4% of children with bilastine and 7.9% of children with placebo (p = 0.337). The total number of adverse events occurring during treatment was also comparable (67.8 vs. 67.5%; p = 0.952), as were serious adverse events (1.0 vs. 3.1%; p = 0.165) and adverse events leading to discontinuation of treatment (1.0 vs. 0.5%; p = 1.0). The most frequent adverse events were headache, allergic conjunctivitis, cough, nasopharyngitis, allergic rhinitis, pyrexia, and viral infection.
Conclusion
The presented analyses showed comparable pharmacokinetic parameters of bilastine (AUC and Cmax) in children aged 6–11 years at a dosage of 10 mg/day and in adults at a dosage of 20 mg/day. They also confirmed the safety of bilastine 10 mg comparable to placebo in the age group 6–11 years. These conclusions demonstrate that the pediatric dosage of bilastine 10 mg/day is suitable for the treatment of allergic rhinoconjunctivitis and urticaria in children in this age group.
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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: 801–805, doi: 10.1007/s00431-019-03559-6.
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