Safety and Tolerability of Bilastine 10 mg in Children with Allergic Diseases


eMediNexus    23 December 2022

It is necessary to characterize the pharmacokinetics and safety of medicines for pediatric use according to regulations. Studies have demonstrated that a 10-mg dose of bilastine in children aged 2 to <12 years provides an equivalent systemic exposure as 20 mg in adults. The present study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria.


It randomized the children to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks and assessed treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ) for establishing the safety.


The study found:


  • Noninferiority between bilastine 10 mg and placebo based on a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks′ treatment (31.5% vs. 32.5%).
  • No clinically relevant differences between bilastine 10 mg and placebo from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores.
  • Occurrence of mild or moderate intensity TEAEs.
  • Study termination by two patients in the bilastine 10 mg and 1 patient in the placebo group due to TEAEs.


This study shows similar safety and tolerability profile of bilastine 10 mg to a placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria.


Source: Novák Z, Yáñez A, Kiss I, et al; “Bilastine Paediatric Safety Study Group”. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases. Pediatr Allergy Immunol. 2016;27(5):493-8. 

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