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

Mark Ballow; M. Berger; F. A. Bonilla; R. H. Buckley; C. H. Cunningham-Rundles; P. Fireman; M. Kaliner; H. D. Ochs; S. Skoda-Smith; M. T. Sweetser; H. Taki; C. Lathia

doi:10.1046/j.1423-0410.2003.00286.x

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

Mark Ballow
, M. Berger
, F. A. Bonilla
, R. H. Buckley
, C. H. Cunningham-Rundles
, P. Fireman
, M. Kaliner
, H. D. Ochs
, S. Skoda-Smith
, M. T. Sweetser
, H. Taki
, C. Lathia

Pediatrics

Case Western Reserve University
Boston Children's Hospital
Duke University
Icahn School of Medicine at Mount Sinai
University of Pittsburgh
Institute for Asthma and Allergy
University of Washington
University of Florida
Fort Wayne Medical Institute
Bayer AG

Research output: Contribution to journal › Article › peer-review

49 Scopus citations

Abstract

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

Original language	English
Pages (from-to)	202-210
Number of pages	9
Journal	Vox Sanguinis
Volume	84
Issue number	3
DOIs	https://doi.org/10.1046/j.1423-0410.2003.00286.x
State	Published - Apr 2003

Keywords

Gamma globulin
Immunoglobulin
IVIG
Pharmacokinetics
Primary immunodeficiency

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10.1046/j.1423-0410.2003.00286.x

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Ballow, M., Berger, M., Bonilla, F. A., Buckley, R. H., Cunningham-Rundles, C. H., Fireman, P., Kaliner, M., Ochs, H. D., Skoda-Smith, S., Sweetser, M. T., Taki, H., & Lathia, C. (2003). Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex™, 10%). Vox Sanguinis, 84(3), 202-210. https://doi.org/10.1046/j.1423-0410.2003.00286.x

@article{cdee79b366bb49689f0c4c391078492a,

title = "Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10\% (Gamunex{\texttrademark}, 10\%)",

abstract = "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{\texttrademark}, 10\%), formulated with glycine, with the licensed solvent-detergent (SD)-treated intravenous immunoglobulin IGIV-SD, 10\% (Gamimune",

keywords = "Gamma globulin, Immunoglobulin, IVIG, Pharmacokinetics, Primary immunodeficiency",

author = "Mark Ballow and M. Berger and Bonilla, \{F. A.\} and Buckley, \{R. H.\} and Cunningham-Rundles, \{C. H.\} and P. Fireman and M. Kaliner and Ochs, \{H. D.\} and S. Skoda-Smith and Sweetser, \{M. T.\} and H. Taki and C. Lathia",

year = "2003",

month = apr,

doi = "10.1046/j.1423-0410.2003.00286.x",

language = "English",

volume = "84",

pages = "202--210",

journal = "Vox Sanguinis",

issn = "0042-9007",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "3",

}

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 2003, 'Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex™, 10%)', Vox Sanguinis, vol. 84, no. 3, pp. 202-210. https://doi.org/10.1046/j.1423-0410.2003.00286.x

TY - JOUR

T1 - Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex™, 10%)

AU - Ballow, Mark

AU - Berger, M.

AU - Bonilla, F. A.

AU - Buckley, R. H.

AU - Cunningham-Rundles, C. H.

AU - Fireman, P.

AU - Kaliner, M.

AU - Ochs, H. D.

AU - Skoda-Smith, S.

AU - Sweetser, M. T.

AU - Taki, H.

AU - Lathia, C.

PY - 2003/4

Y1 - 2003/4

N2 - 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

AB - 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

KW - Gamma globulin

KW - Immunoglobulin

KW - IVIG

KW - Pharmacokinetics

KW - Primary immunodeficiency

UR - https://www.scopus.com/pages/publications/0037398124

U2 - 10.1046/j.1423-0410.2003.00286.x

DO - 10.1046/j.1423-0410.2003.00286.x

M3 - Article

C2 - 12670369

AN - SCOPUS:0037398124

SN - 0042-9007

VL - 84

SP - 202

EP - 210

JO - Vox Sanguinis

JF - Vox Sanguinis

IS - 3

ER -

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

Abstract

Keywords

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