アブストラクト | OBJECTIVES: Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information. METHODS: This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023. RESULTS: During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycle for SC immunoglobulins. Following the onset of an infusion-related reaction, the infusion was most commonly discontinued (87.7%) or the infusion rate reduced (9.1%). In 64 cases, resolution of the reaction allowed the continuation of treatment with reduced infusion rates (65%), premedication (28%), or both (7%). Resumption of the infusion did not lead to recurrence in 60% of cases. For subsequent cycles, administration of the same formulation (n=100) resulted in recurrence in 40% of cases, while switching to a different formulation (n=16) was associated with recurrence in 75% of cases. CONCLUSION: Infusion-related reactions to immunoglobulins most frequently present as flu-like syndromes or cardiovascular disturbances, which are typically resolved by reducing the infusion rate or discontinuing the infusion. Resumption of the infusion is feasible following resolution, using a reduced rate or premedication. The findings suggest that switching to a different formulation of the same administration route does not confer a practical advantage. |
ジャーナル名 | Therapie |
Pubmed追加日 | 2025/2/10 |
投稿者 | Bobet, Aurelie; Bravo, Justine; Aubin-Beale, Eyrian; Bertin, Blandine; Montastruc, Francois; Barus, Romain |
組織名 | Departement de pharmacologie medicale et clinique, centre de pharmacovigilance et;de pharmacoepidemiologie, faculte de medecine, hopital universitaire de Toulouse,;31000 Toulouse, France.;Centre de pharmacovigilance, hopital universitaire de Nancy, 54000 Nancy, France.;Centre de pharmacovigilance, hopital universitaire de Lyon, 69000 Lyon, France.;31000 Toulouse, France. Electronic address: romain.barus@univ-tlse3.fr. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39924412/ |