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

Content Provider	Springer Nature Link
Author	Wasserman, Richard L. Melamed, Isaac Kobrynski, Lisa Strausbaugh, Steven D. Stein, Mark R. Sharkhawy, Marlies Engl, Werner Leibl, Heinz Sobolevsky, Luba Gelmont, David Schiff, Richard I. Grossman, William J.
Copyright Year	2011
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.
Starting Page	323
Ending Page	331
Page Count	9
File Format	PDF
ISSN	02719142
Journal	Journal of Clinical Immunology
Volume Number	31
Issue Number	3
e-ISSN	15732592
Language	English
Publisher	Springer US
Publisher Date	2011-03-22
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Subcutaneous immunoglobulin immunodeficiency disease pharmacokinetic comparison efficacy tolerability Internal Medicine Immunology Infectious Diseases Medical Microbiology
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Immunology

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