Safety and tolerability of a novel chromatography‐based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura

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Abstract
Intravenous immunoglobulin (IGIV) therapy is generally considered to be a safe and effective treatment for idiopathic thrombocytopenic purpura (ITP). The usual initial treatment dose is 1–2 g/kg body weight, which results in an extended infusion time, significantly impacting patients' day‐to‐day activities. Two crossover studies assessed the safety and tolerability of a novel IGIV preparation (IGIV‐C; Gamunex®, 10%) when infused at rates ranging from 0.08 mL/kg/min (the standard maximum licensed rate) to 0.14 mL/kg/min in patients with ITP. The first study included 28 patients and 3 infusion rates; 0.08, 0.11, and 0.14 mL/kg/min. The second study included 8 patients and 2 infusion rates; 0.08 and 0.14 mL/kg/min were evaluated. The incidence of infusion‐related adverse events was similar for all infusion rates. Headache was the most commonly reported infusion‐related adverse event. The incidence, combined for Studies 1 and 2, was 14.7% (n = 34), 18.2% (n = 22), and 19.4% (n = 31) of patients, for each infusion rate of 0.08, 0.11, and 0.14 mL/kg/min, respectively. The majority were mild in severity. None of the other drug‐related, treatment‐emergent events were serious; most were mild, in spite of the higher rate of fluid loading over a shorter period of time for patients infused at 0.14 mL/kg/min. There were no clinically important changes in parameters that distinguished between infusion rates; there were no signs of hemolysis. The results suggest that IGIV‐C infused at rates up to 0.14 mL/kg/min in patients with ITP is well tolerated. Am. J. Hematol., 2007.