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

Publication ,  Journal Article
Ballow, M; Berger, M; Bonilla, FA; Buckley, RH; Cunningham-Rundles, CH; Fireman, P; Kaliner, M; Ochs, HD; Skoda-Smith, S; Sweetser, MT; Taki, H ...
Published in: Vox Sang
April 2003

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%.

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Published In

Vox Sang

DOI

ISSN

0042-9007

Publication Date

April 2003

Volume

84

Issue

3

Start / End Page

202 / 210

Location

England

Related Subject Headings

  • Treatment Outcome
  • Therapeutic Equivalency
  • Pharmacokinetics
  • Maltose
  • Male
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Humans
  • Half-Life
  • Glycine
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ballow, M., Berger, M., Bonilla, F. A., Buckley, R. H., Cunningham-Rundles, C. H., Fireman, P., … Lathia, C. (2003). Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). Vox Sang, 84(3), 202–210. https://doi.org/10.1046/j.1423-0410.2003.00286.x
Ballow, M., M. Berger, F. A. Bonilla, R. H. Buckley, C. H. Cunningham-Rundles, P. Fireman, M. Kaliner, et al. “Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).Vox Sang 84, no. 3 (April 2003): 202–10. https://doi.org/10.1046/j.1423-0410.2003.00286.x.
Ballow M, Berger M, Bonilla FA, Buckley RH, Cunningham-Rundles CH, Fireman P, et al. Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). Vox Sang. 2003 Apr;84(3):202–10.
Ballow, M., et al. “Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).Vox Sang, vol. 84, no. 3, Apr. 2003, pp. 202–10. Pubmed, doi:10.1046/j.1423-0410.2003.00286.x.
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. Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). Vox Sang. 2003 Apr;84(3):202–210.
Journal cover image

Published In

Vox Sang

DOI

ISSN

0042-9007

Publication Date

April 2003

Volume

84

Issue

3

Start / End Page

202 / 210

Location

England

Related Subject Headings

  • Treatment Outcome
  • Therapeutic Equivalency
  • Pharmacokinetics
  • Maltose
  • Male
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Humans
  • Half-Life
  • Glycine