{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T14:14:42Z","timestamp":1715955282694},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2006,11,15]],"date-time":"2006-11-15T00:00:00Z","timestamp":1163548800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2007,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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\u20132 g\/kg body weight, which results in an extended infusion time, significantly impacting patients' day\u2010to\u2010day activities. Two crossover studies assessed the safety and tolerability of a novel IGIV preparation (IGIV\u2010C; Gamunex\u00ae, 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\u2010related adverse events was similar for all infusion rates. Headache was the most commonly reported infusion\u2010related adverse event. The incidence, combined for Studies 1 and 2, was 14.7% (<jats:italic>n<\/jats:italic> = 34), 18.2% (<jats:italic>n<\/jats:italic> = 22), and 19.4% (<jats:italic>n<\/jats:italic> = 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\u2010related, treatment\u2010emergent 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\u2010C infused at rates up to 0.14 mL\/kg\/min in patients with ITP is well tolerated. Am. J. 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