Bilastine in allergic rhinoconjunctivitis and urticaria: a practical approach to treatment decisions based on queries received by the medical information department

Bilastine in allergic rhinoconjunctivitis and urticaria: a practical approach to treatment decisions based on queries received by the medical information department

Article Page

Abstract 

Background: Bilastine is a safe and effective commonly prescribed non-sedating H1-antihistamine approved for symptomatic treatment in patients with allergic disorders such as rhinoconjunctivitis and urticaria. It was evaluated in many patients throughout the clinical development required for its approval, but clinical trials generally exclude many patients who will benefit in everyday clinical practice (especially those with coexisting diseases and/or being treated with concomitant drugs). Following its introduction into clinical practice, the Medical Information Specialists at Faes Farma have received many practical queries regarding the optimal use of bilastine in different circumstances.

Data sources and methods: Queries received by the Medical Information Department and the responses provided to senders of these queries.

Results: The most frequent questions received by the Medical Information Department included the potential for drug-drug interactions with bilastine and commonly used agents such as anticoagulants (including the novel oral anticoagulants), antiretrovirals, antituberculosis regimens, corticosteroids, digoxin, oral contraceptives, and proton pump inhibitors. Most of these medicines are not usually allowed in clinical trials, and so advice needs to be based upon the pharmacological profiles of the drugs involved and expert opinion. The pharmacokinetic profile of bilastine appears favourable since it undergoes negligible metabolism and is almost exclusively eliminated via renal excretion, and it neither induces nor inhibits the activity of several isoenzymes from the CYP 450 system. Consequently, bilastine does not interact with cytochrome metabolic pathways. Other queries involved specific patient groups such as subjects with renal impairment, women who are breastfeeding or who are trying to become pregnant, and patients with other concomitant diseases. Interestingly, several questions related to topics that are well covered in the Summary of Product Characteristics (SmPC), which suggests that this resource is not being well used.

Conclusions: Overall, this analysis highlights gaps in our knowledge regarding the optimal use of bilastine. Expert opinion based upon an understanding of the science can help in the decision-making, but more research is needed to provide evidence-based answers in certain circumstances.

Keywords: antihistamines, bilastine, drug information, drug interactions, medical information services, pregnancy, renal disease.

Abbreviations: AME, Aviation Medical Examiner; AR, allergic rhinitis; ATCSs, air traffic control specialists; BCRP, breast-cancer resistance protein; BPH, benign prostatic hypertrophy; CCU, cold contact urticaria; CRRT, continuous renal replacement therapy; EMA, European Medicines Agency; ERA, Environmental Risk Assessment; FAA, Federal Aviation Administration; GPs, general practitioners; MAT, multi-attribute task; MDR1, multidrug resistance protein 1; OAT, organic anion transporter; OCT2, organic cation transporter2; P-gp, p-glycoprotein; PET, positron emission tomography; SDLP, standard deviation of lateral position; SmPC, summary of product characteristics; TEAEs, treatment-emergent adverse events; WADA, World Anti-doping Agency

Citation: Leceta A, Sologuren A, Valiente R, Campo C, Labeaga L. Bilastine in allergic rhinoconjunctivitis and urticaria: a practical approach to treatment decisions based on queries received by the medical information department. Drugs in Context 2017; 6: 212500. DOI: 10.7573/dic.212500.

Disclosure and potential conflicts of interest: All authors are employees of Faes Farma SA, 48940-Leioa, Bizkaia, Spain. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: http://www.drugsincontext.com/wp-content/uploads/2017/02/dic.212500-COI.pdf.

Contributions: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors contributed equally to the study design, the collection, analysis and interpretation of data and the writing of the manuscript.

Acknowledgements: We thank Steve Clissold, PhD, Content Ed Net, for editorial assistance in the preparation of this manuscript; funding for editorial assistance was provided by Faes Farma S.A.

Funding declaration: This research was supported by FAES FARMA SA.

Copyright: Copyright © 2017 Leceta A, Sologuren A, Valiente R, Campo C, Labeaga L. Distributed under the terms of the Creative Commons License Deed CC BY NC ND 3.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2017 Leceta A, Sologuren A, Valiente R, Campo C, Labeaga L. https://doi.org/10.7573/dic.212500. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 3.0.

Article URL: http://www.drugsincontext.com/bilastine-in-allergic-rhinoconjunctivitis-and-urticaria-a-practical-approach-to-treatment-decisions-based-on-queries-received-by-the-medical-information-department

Correspondence: Amalia Leceta, Medical Department, Faes Farma SA, 48940-Leioa, Bizkaia, Spain. aleceta@faes.es

Provenance: Submitted, two set of peer review comments, Editor-in-Chief evaluation and acceptance

Submitted: 20 December 2016; Peer review evaluation: 23 December 2016; Publication date: 3 February 2017

Drugs in Context is published by BioExcel Publishing Ltd. Registered office: 14 Weller Street, London, SE1 1QU, UK

BioExcel Publishing Limited is registered in England Number 10038393. VAT GB 252772009

For all manuscript and submissions enquiries, contact Dr Gordon Mallarkey, Editor-in-Chief gordon.mallarkey@bioexcelpublishing.com

For all permissions, rights and reprints, contact Peter Clarke peter.clarke@bioexcelpublishing.com

Download free full text PDF