title: [Adverse events in 1395 infusions with different intravenous gammaglobulin products].
abstract: The processes of isolation and sterilization of intravenous gamma globulin (IVIG) affect the end product characteristics and, therefore, its tolerability. Different products have different incidences of adverse reactions. The aim of this study was to quantify the immediate adverse events (AE) caused by the different IVIG preparations. We analyzed 1 395 infusions in 28 patients, with a median of 32.5 per subject (range 2-214), using six different IVIG preparations, with an average dose 40.3 ± 8.3 g. One thousand and thirty-one infusions were analyzed retrospectively and 364 prospectively. Patients used a mean of 2.68 ± 1.8 different IVIGs, with a median of 2 (range 1-6) per person. The number of trademarks used was related to the number of infusions received, r = 0.73. AE presented in 24 (2.3%) of 1 031 infusions retrospectively analyzed, affecting 11 of 23 patients enrolled, with a mean of 2.18 ± 1.08 AE per subject. Of 24 patients and 364 infusions prospectively analyzed, AE were observed in 14 patients and in 32 (7.2%) procedures. Twenty-four (42.9%) of 56 AE were mild, 31 (55.5%) moderate and one (1.8%) severe. The infusion rate was 9.04 ± 6 g/h for those presenting AE vs. 10.6 ± 4.6 g/h for those who did not (p = 0.31, NS). The incidence, severity and proportion of patients with AE for each brand of IVIG were very different from each other. This information should be taken into account when selecting the IVIG to be used.
authors.affiliation: Unidad de Alergia, Asma e Inmunología Clínica, Hospital Británico de Buenos Aires.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Malbrán
authors.forename: Blas
authors.initials: B
authors.lastname: Larrauri
authors.forename: María Cecilia
authors.initials: MC
authors.lastname: Juri
authors.forename: Diego S
authors.initials: DS
authors.lastname: Fernández Romero
mesh_terms: D015331:Cohort Studies; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects*; D007155:Immunologic Factors / Q000009:adverse effects*; D007262:Infusions, Intravenous; D008297:Male; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D005719:gamma-Globulins / Q000009:adverse effects*
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D005719:gamma-Globulins
keywords: IVIG; adverse events; hypogammaglobulinemia