Safety and Tolerability of Increased Rate of Infusion of Intravenous Immunoglobulin G, 10% in Antibody-Deficient Patients

Abstract

The incidence and severity of infusion-related adverse events (AEs) after infusions of IGIV-C, 10%, (Gamunex) at 0.14 mL/kg/min versus 0.08 mL/kg/min (standard rate) were compared. Patients with confirmed PID received two infusions 3-4 weeks apart with IGIV-C, 10% 400-600 mg/kg. Patients received their first infusion at 0.08 or 0.14 mL/kg/min and their second infusion 3-4 weeks later at the alternate rate, at an established step-wise rate increase. Ninety-seven of 100 patients remained valid for safety assessment. There were three infusion-related reactions at the standard rate and five at the increased rate. The incidence of all reported AEs was similar for both rates. Despite the time required for step-wise increases in infusion rate, the increased rate resulted in a shortened overall infusion time. Increasing the rate of infusion of IGIV-C, 10% by 75% up to 0.14 mL/kg/min (840 mg/kg/h) was well tolerated, suggesting safe administration of IGIV-C, 10% at this rate.