Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review

Expert Opinion on Drug Safety
Alain Didier, Brigitte Bons

Abstract

The 5-grass pollen tablet (Oralair®, Stallergenes, Antony, France) is a once-daily preseasonal and coseasonal sublingual immunotherapy (SLIT) that is effective in controlling the symptoms of allergic rhinoconjunctivitis and in reducing the need for symptomatic medication. The body of safety data gathered from the 5-grass pollen tablet clinical development program, post-approval studies, and more than 6 years of real-life experience demonstrates the safety and tolerability profile of the 5-grass pollen tablet across all age groups. Adverse events (AEs) are generally mild or moderate in severity, and rarely lead to treatment discontinuation. AEs also tend to decline in frequency and severity over time and with repeated treatment. The most frequent treatment-emergent AEs are local-site oropharyngeal reactions (e.g., oral pruritus, throat irritation, tongue pruritus, mouth edema, ear pruritus), which are consistent with the sublingual route of administration. The first dose of the 5-grass pollen tablet should be administered under the supervision of an experienced physician, to allow for optimal monitoring and timely management of AEs, should they occur. The 5-grass pollen tablet can be administered at home after the first dose, an...Continue Reading

References

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Citations

Sep 12, 2015·Expert Review of Clinical Immunology·Giorgio CiprandiAmelia Licari
Dec 25, 2015·Clinical and Translational Allergy·Pascal DemolyTarik Yalaoui
Nov 26, 2015·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Liesbeth RasRanny van Weissenbruch
Oct 29, 2015·Immunotherapy·Cristoforo IncorvaiaErminia Ridolo
Apr 9, 2016·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Désirée Larenas-Linnemann
Apr 17, 2016·The Journal of Allergy and Clinical Immunology·Linda S CoxPhilippe Devillier
May 25, 2016·Expert Review of Clinical Immunology·Giovanni PassalacquaPascal Demoly
Nov 7, 2016·The Journal of Allergy and Clinical Immunology. in Practice·Tolly G EpsteinSten Dreborg
Nov 8, 2016·The Journal of Allergy and Clinical Immunology·Claus Bachert, Elien Gevaert
May 22, 2020·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·Montserrat Alvaro-LozanoMarta Vazquez-Ortiz
Sep 28, 2018·Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology·Patrick BlinMathieu Molimard
Aug 14, 2019·Expert Review of Clinical Immunology·Giorgio Walter CanonicaLaurent Mascarell
May 19, 2020·The Journal of Allergy and Clinical Immunology. in Practice·Moisés A CalderonHendrik Nolte
May 25, 2021·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Susan WasermanErnie Avilla

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