Safety of Immunoglobulin G (Gammaraas®) in Patients Treated at a High-Complexity Clinic: A Descriptive Study
DOI:
https://doi.org/10.30827/ars.v66i3.32021Keywords:
Adverse effects; intravenous immunoglobulins; pharmacovigilance; therapeutic uses; retrospective studiesAbstract
Introduction: Recent years have seen an increase in the use of intravenous immunoglobulin (IVIG) for treating primary and secondary immunodeficiencies, as well as immune modulation. Despite being generally safe, IVIG can cause mild to severe adverse events. This study aimed to describe safety aspects of Gammaraas® 5 % in high-complexity clinic patients between 2020 and 2022.
Method: A retrospective observational study conducted at a high-complexity clinic between 2000 and 2022, involving patients treated with intravenous immunoglobulin G. Medical records were analyzed to collect demographic information, indication, medication dosage, and adverse events. Data were presented as absolute and relative frequencies for qualitative variables and measures of central tendency for quantitative variables. The ethical guidelines of the Helsinki Declaration were followed, and the study was approved by the institutional ethics committee.
Results: During the study period, 49 patients received the intravenous immunoglobulin G under the study. Males predominated with 27 (55.1 %), equally distributed between adults and pediatrics, with a median age of 17.2 years (IQR: 3.7-48.2), who received 98 infusions. Five patients (10.2 %) experienced adverse reactions, most of them classified as mild.The main indications were: idiopathic thrombocytopenic purpura, inflammatory myopathy, Guillain-Barre syndrome and “Kawasaki” lymphonodular mucocutaneous syndrome. Two patients experienced severe reactions wich were finally classified as not related to intravenous immunoglobulin G.
Conclusions: The intravenous administration of Gammaraas® 5 % was safe in 90 % of cases. The documented reactions were mild, which is consistent with the literature.
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