Relevant criteria for selecting an intravenous immunoglobulin preparation for clinical use.

Over the past several decades, the use of intravenous human normal immunoglobulin (IVIg) products in a diverse range of immunodeficiency, inflammatory and infectious disorders has increased significantly. Newer manufacturing processes have increased the yield of intact IVIg molecules and have also improved the tolerability and safety of these products, including reducing the transmission risk of blood-borne diseases. While there are no appreciable differences between the numerous commercially available IVIg products in terms of efficacy, different manufacturing processes and the final composition of IVIg products have resulted in different safety and tolerability profiles. The tolerability profile of different IVIg products may be idiosyncratic for individual patients and may not be predictable, based on product characteristics. Consequently, patients receiving an IVIg product should be carefully monitored at initial exposure, and switching of products should be avoided. To achieve the best outcomes in patients requiring IVIg therapy, treatment should be tailored to the patient's needs. The risk/benefit profile of an IVIg in relation to patient risk factors and the underlying immune deficiency, or autoimmune or inflammatory disorder should be considered when deciding on the most appropriate therapy.