Pharmacokinetics and Safety of Bilastine 10 mg in Children Aged 6–11 Years

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 (C_max) 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 C_max) 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.