Intravenous immunoglobulin G use and pharmacovigilance in a tertiary care children’s hospital

Abstract

Introduction. Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is consideredasafetherapy,theincidenceofadverse reactionsreportedinthebibliographyrangesfrom 1%to81%.Theobjectiveofthisstudywastoassess IVIG use and describe related adverse events in a tertiary care children’s hospital. Population and methods. This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children’s hospitalintheAutonomousCityofBuenosAires were assessed. The analysis unit was each IVIG infusion,andthemainvariablewasthepresence of adverse reactions. Results. A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedicationwasindicated;diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal. Conclusions. The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients.