Clinical Experience with a New Solvent Detergent-Treated Intravenous Immunoglobulin Free of Hypotensive Effects

Objective: To see if modifications to the processing of intravenous immunoglobulin to include a virus inactivation stage alter immunoglobulin G (IgG) resulting in hypotension in patients. Methods: Clinical trials were done involving extensive patient monitoring during infusion: in vitro-testing for markers of hypotension, and in vivo-an animal model which closely simulates clinical use. Results: No hypotensive response was seen in the animal model or clinical trial. Conclusions: The production process used does not damage IgG or create vaso-active kinins as the preparation was free of hypotensive effects.