Journal of Clinical Immunology

, Volume 31, Issue 3, pp 323–331

Efficacy, Safety, and Pharmacokinetics of a 10% Liquid Immune Globulin Preparation (GAMMAGARD LIQUID, 10%) Administered Subcutaneously in Subjects with Primary Immunodeficiency Disease

  • Richard L. Wasserman
  • Isaac Melamed
  • Lisa Kobrynski
  • Steven D. Strausbaugh
  • Mark R. Stein
  • Marlies Sharkhawy
  • Werner Engl
  • Heinz Leibl
  • Luba Sobolevsky
  • David Gelmont
  • Richard I. Schiff
  • William J. Grossman
Article

DOI: 10.1007/s10875-011-9512-z

Cite this article as:
Wasserman, R.L., Melamed, I., Kobrynski, L. et al. J Clin Immunol (2011) 31: 323. doi:10.1007/s10875-011-9512-z

Abstract

A multi-center, prospective, open-label study was conducted in primary immunodeficiency disease patients to determine the tolerability and pharmacokinetics of a 10% liquid IgG preparation administered subcutaneously. Forty-nine subjects (3–77 years old) were enrolled. Pharmacokinetic equivalence of subcutaneous treatment was achieved at a median dose of 137% of the intravenous dose, with a mean trough IgG level of 1,202 mg/dL at the end of the assessment period. The overall infection rate during subcutaneous treatment was 4.1 per subject-year. Three acute serious bacterial infections were reported, resulting in a rate of 0.067 per subject-year. A low overall rate of temporally associated adverse events (8%), and a very low rate of infusion site adverse events (2.8%), was seen at volumes up to 30 mL/site and rates ≤30 mL/h/site. Thus, subcutaneous replacement therapy with a 10% IgG preparation proved effective, safe and well-tolerated in our study population of subjects with primary immunodeficiency disease.

Keywords

Subcutaneous immunoglobulinprimary immunodeficiency diseasepharmacokinetic comparisonefficacytolerability

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Richard L. Wasserman
    • 1
  • Isaac Melamed
    • 2
  • Lisa Kobrynski
    • 3
  • Steven D. Strausbaugh
    • 4
  • Mark R. Stein
    • 5
  • Marlies Sharkhawy
    • 6
  • Werner Engl
    • 6
  • Heinz Leibl
    • 6
  • Luba Sobolevsky
    • 7
  • David Gelmont
    • 7
  • Richard I. Schiff
    • 8
  • William J. Grossman
    • 8
  1. 1.Pediatrics Allergy/Immunology Assoc., PADallasUSA
  2. 2.1st Allergy & Clinical Research CenterCentennialUSA
  3. 3.Emory Children’s CenterAtlantaUSA
  4. 4.University Hospitals of ClevelandClevelandUSA
  5. 5.Allergy Associates of the Palm BeachesNorth Palm BeachUSA
  6. 6.Baxter Innovations GmbHViennaAustria
  7. 7.Baxter Healthcare CorporationWestlake VillageUSA
  8. 8.Baxter Healthcare CorporationWestlake VillageUSA