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Product Highlight - Bilaxten ODT
16 Mar 2022
A second generation H1 antihistamine formulation with children* in mind1
• Indicated for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight ≥20 kg1
• Convenient and simple once-a-day, one tablet dosing1
• Has similar efficacy in children as with Bilastine 20 mg in adults1,3*^
• An effect similar to placebo on sleepiness and sedation in children4
• Melt in the mouth convenience in a red grape flavour1
*As demonstrated in an ontogenic PK modelling study by Vozmediano et al (2017). The study used a semi-mechanistic approach to predict Bilastine PK in children assuming the same pharmacodynamics as described in adults. The model was used to stimulate the time evolution of plasma levels and wheal and flare effects after several doses and design an adaptive PK trial in children that was then confirmed using data from the first recruits by comparing observations with model predictions.
^According to guidelines, the proven efficacy in adults and adolescents can be extrapolated to children, having demonstrated that the systemic exposure with 10 mg bilastine in children 6 to 11 years with a body weight of at least 20 kg is equivalent to the exposure in adults with 20 mg bilastine.
References:
1. BILAXTEN 10 mg orodispersible tablet SmPC (Nov 2020).
2. Church MK, Tiongo-Recto M, Ridolo E, Novak Z. Bilastine: a lifetime companion for the treatment of allergies, Current Medical Research and Opinion, DOI:10.1080/03007995.2019.1681134.
3. Vozmediano V, Sologuren A, Lukas JC, et al. Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design. Pharm Res. 2017;34(12):2720-2734.
4. Novák Z, Yáñez A, Kiss I, et al. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases. Pediatr Allergy Immunol. 2016;27(5):493-8.
For healthcare professionals only
MY/BIX/08/2021/003
• Indicated for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight ≥20 kg1
• Convenient and simple once-a-day, one tablet dosing1
• Has similar efficacy in children as with Bilastine 20 mg in adults1,3*^
• An effect similar to placebo on sleepiness and sedation in children4
• Melt in the mouth convenience in a red grape flavour1
*As demonstrated in an ontogenic PK modelling study by Vozmediano et al (2017). The study used a semi-mechanistic approach to predict Bilastine PK in children assuming the same pharmacodynamics as described in adults. The model was used to stimulate the time evolution of plasma levels and wheal and flare effects after several doses and design an adaptive PK trial in children that was then confirmed using data from the first recruits by comparing observations with model predictions.
^According to guidelines, the proven efficacy in adults and adolescents can be extrapolated to children, having demonstrated that the systemic exposure with 10 mg bilastine in children 6 to 11 years with a body weight of at least 20 kg is equivalent to the exposure in adults with 20 mg bilastine.
References:
1. BILAXTEN 10 mg orodispersible tablet SmPC (Nov 2020).
2. Church MK, Tiongo-Recto M, Ridolo E, Novak Z. Bilastine: a lifetime companion for the treatment of allergies, Current Medical Research and Opinion, DOI:10.1080/03007995.2019.1681134.
3. Vozmediano V, Sologuren A, Lukas JC, et al. Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design. Pharm Res. 2017;34(12):2720-2734.
4. Novák Z, Yáñez A, Kiss I, et al. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases. Pediatr Allergy Immunol. 2016;27(5):493-8.
For healthcare professionals only
MY/BIX/08/2021/003