Journal
VOX SANGUINIS
Volume 84, Issue 3, Pages 202-210Publisher
WILEY
DOI: 10.1046/j.1423-0410.2003.00286.x
Keywords
gamma globulin; immunoglobulin; IVIG; pharmacokinetics; primary immunodeficiency
Categories
Ask authors/readers for more resources
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(TM), 10%), formulated with glycine, with the licensed solvent-detergent (SD)-treated intravenous immunoglobulin IGIV-SD, 10% (Gamimune(R)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 (t(1/2)) of 35 and 34 days, respectively. IGIV-C, 5%, was bioequivalent to IGIV-C, 10%, with t(1/2) 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%.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available