Infusion-related reactions with human polyclonal immunoglobulins: Analysis from the French National Pharmacovigilance Database

Authors: Bobet, A; Bravo, J; Aubin-Beale, E; Bertin, B; Barus, R; Montastruc, F

Affiliations: Hop Univ Toulouse, Fac Med, Ctr Pharmacovigilance & Pharmacoepidemiol, Dept Pharmacol Medicale & Clin, F-31000 Toulouse, France; Hop Univ Nancy, Ctr Pharmacovigilance, F-54000 Nancy, France; Hop Univ Lyon, Ctr Pharmacovigilance, F-69000 Lyon, France.

Publication: Therapie ; 2025; 80. 553–560

ABSTRACT: 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.