Tolerability of intravenous immunoglobulins: focus on adverse reactions

Therapy with immunoglobulins is a major advance in medical therapy, and has further evolved due to the availability of preparations that ensure biological efficacy and virtually eliminate the IgG aggregates that are responsible for severe adverse events. Adverse reactions associated with administration of immunoglobulins are classified as mild, moderate or severe depending on the clinical presentation, and include renal and neurological complications in addition to thromboembolic events. Herein, recent literature on the tolerability of IVIG is reviewed, and an overview of the experience in Italy with IVIGs is provided. The most significant experience in Italy on IVIGs is from a multicentre, prospective, longitudinal study carried out in 10 hospital clinics that are all members of the primary immunodeficiency network (IPINet). For this study, a single formulation of immunoglobulin was utilized (IgVENA Kedrion), which represents 75% of the national IVIG market. The total incidence of adverse reactions per patient/year was 0.0005%. All adverse reactions were mild in intensity (fever, headache), and in 66% of cases occurred within 24 hours after infusion. It is important to keep in mind that the risks associated with any pharmacological therapy depend not only on the drug itself, but are also related to individual patient characteristics. In this regard, in high-risk patients a low rate of infusion of non-hyperosmolar IVIG, together with adequate hydration, can help to avoid renal insufficiency, thromboembolic events and aseptic meningitis.