Use of Bilastine in Pediatrics − Pathway to Improving Concentration and Performance of Young Allergy Sufferers

Indications of Bilastine in Pediatrics

According to the current SPC, bilastine (Xados 10 mg orodispersible tablets) can be indicated in the Czech Republic for children aged 6 years and older with a body weight of at least 20 kg, in case of:

• allergic rhinoconjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis);
• urticaria.

Dosage and Method of Administration in Children

• In children aged 6−11 years (with a body weight of at least 20 kg), bilastine is administered at a dose of 10 mg once daily.
• The tablets should be taken 1 hour before or 2 hours after a meal.
• Bilastine should not be taken concurrently with fruit juices, especially grapefruit juice (if consumed, bilastine should be taken at least 2 hours apart from fruit juices).
• The duration of treatment depends on the type, duration, and course of the symptoms, and it can be intermittent or continuous, depending on the frequency of allergen exposure.

Skin Relief for Up to 24 Hours

Bilastine is a representative of second-generation antihistamines with selective action on peripheral H₁ receptors. It shows almost no affinity for central muscarinic receptors. Its administration results in the inhibition of skin reactions induced by histamine (redness, swelling) for up to 24 hours. 

Preferences and Recommendations of European Professional Societies for the Treatment of Pediatric Patients

Based on the resolution of EAACI/GA²LEN/EDF/WAO (European Academy of Allergology and Clinical Immunology, Global Asthma and Allergy European Network, European Dermatology Forum, World Allergy Organization), an update of the guidelines for urticaria therapy was issued in January 2018. According to this recommendation, modern second-generation antihistamines are clearly preferred over first-generation antihistamines, which have a significant sedative effect, in the treatment of urticaria in children. 

Second-generation antihistamines with proven efficacy and safety in the pediatric population, according to these guidelines, include primarily bilastine, cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine, and rupatadine.

Despite modern second-generation antihistamines being recognized by European professional societies as first-line drugs in the pediatric population, first-generation antihistamines are still often prescribed to children in clinical practice. The reason is the assumption that there is more experience with these drugs, which mistakenly suggests a better safety profile. Their most significant disadvantage impacting the quality of life of children is the mentioned sedative effect. 

Fewer Negative Effects on the CNS = Better School Performance

The favorable safety profile of bilastine is supported by studies conducted in both adults and children. For example, it was found that administering bilastine has no negative impact on driving motor vehicles. In a multicenter randomized double-blind study published in 2016, conducted on a sample of more than 500 children aged 2−12 years, the favorable safety profile and tolerability of bilastine at a dose of 10 mg over 12 weeks in children with allergic rhinoconjunctivitis or chronic urticaria were confirmed. Given that maintaining a quality sleep pattern and thus sustaining attention and performance in school is crucial in the treatment of children's allergic diseases, bilastine should always be considered as a suitable choice. 

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Sources:
1. Papadopoulos N. G., Zuberbier Z. The safety and tolerability profile of bilastine for chronic urticaria in children. Clin Transl Allergy 2019 Oct 23; 9: 55, doi: 10.1186/s13601-019-0294-3.
2. 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): 493−498, doi: 10.1111/pai.12555.
3. Braunová J., Račanský M. Modern antihistamines in the treatment of allergy − current trends in symptomatic therapy of allergic diseases. Clinical Pharmacology and Pharmacy 2015; 29 (3): 100−104.
4. Zuberbier T., Aberer W., Asero R. et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy 2018; 73 (7): 1393−1414, doi: 10.1111/all.13397.
5. SPC Xados. Available at: www.sukl.cz/modules/medication/download.php?file=SPC139481.pdf&type=spc&as=xados-spc