Safety of subcutaneous immunotherapy with carbamylated allergoids based on data from a pharmacovigilance database.

ABSTRACT

Aims: Allergen immunotherapy aims to induce tolerance, which persists after its discontinuation, to targeted allergens. However, concern exists regarding the use of subcutaneous immunotherapy with whole extracts due to frequently reported events of anaphylactic reactions. Materials & methods: In this pharmacovigilance study, the authors assessed the safety of subcutaneous immunotherapy with the monomeric allergoid Lais-in using a database of adverse reactions documented in real-world postmarketing reports from 2010 to 2020. Results & conclusion: The results showed that more than 171,916 doses of Lais-in were administered from 2010 to 2020, resulting in five adverse drug reactions. Nonserious adverse events, including hives, eye irritation and skin reactions, were reported. These data indicate that monomeric allergoids prevent serious reactions to subcutaneous immunotherapy.