title: 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.
authors.affiliation: National Jewish Medical and Research Center, Denver, Colorado 80206, USA. gelfande@njc.org
authors.forename: Erwin W
authors.initials: EW
authors.lastname: Gelfand
authors.forename: Kim
authors.initials: K
authors.lastname: Hanna
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002210:Caprylates / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method
chemical_list: D002210:Caprylates; D016756:Immunoglobulins, Intravenous