Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).

Published

Journal Article

BACKGROUND AND OBJECTIVES: A new intravenous immunoglobulin (IGIV) process has been developed that integrates efficient inactivation of enveloped virus, using caprylate, with immunoglobulin G (IgG) purification and caprylate removal by column chromatography. Two clinical studies were conducted to compare the pharmacokinetics of the new product, IGIV-C, 10% (Gamunex, 10%), formulated with glycine, with the licensed solvent-detergent (SD)-treated intravenous immunoglobulin IGIV-SD, 10% (Gamimune N, 10%), formulated with glycine, and IGIV-C, 5%, formulated with 10% maltose. MATERIALS AND METHODS: Both studies were randomized, multicentre crossover trials of 18 and 20 (respectively) adult patients with primary humoral immune deficiency in which patients received one IGIV product for three consecutive periods (3-4 weeks) before crossing over to the other product. Pharmacokinetic parameters were determined after the third infusion of each product. RESULTS: IGIV-C, 10% was bioequivalent to IGIV-SD, 10%, with half-lives (t1/2) of 35 and 34 days, respectively. IGIV-C, 5%, was bioequivalent to IGIV-C, 10%, with t1/2 of 35 and 36 days, respectively. The products had comparable safety profiles. CONCLUSIONS: The pharmacokinetic profiles observed in these trials indicate that IGIV-C, 10% may replace, and be administered in a manner similar to, IGIV-SD, 10%.

Full Text

Duke Authors

Cited Authors

  • Ballow, M; Berger, M; Bonilla, FA; Buckley, RH; Cunningham-Rundles, CH; Fireman, P; Kaliner, M; Ochs, HD; Skoda-Smith, S; Sweetser, MT; Taki, H; Lathia, C

Published Date

  • April 2003

Published In

Volume / Issue

  • 84 / 3

Start / End Page

  • 202 - 210

PubMed ID

  • 12670369

Pubmed Central ID

  • 12670369

International Standard Serial Number (ISSN)

  • 0042-9007

Digital Object Identifier (DOI)

  • 10.1046/j.1423-0410.2003.00286.x

Language

  • eng

Conference Location

  • England