1. Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease.
- Author
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Wasserman RL, Melamed I, Kobrynski L, Strausbaugh SD, Stein MR, Sharkhawy M, Engl W, Leibl H, Sobolevsky L, Gelmont D, Schiff RI, and Grossman WJ
- Subjects
- Adolescent, Adult, Agammaglobulinemia complications, Agammaglobulinemia immunology, Agammaglobulinemia microbiology, Agammaglobulinemia pathology, Aged, Bacteria growth & development, Bacterial Infections complications, Bacterial Infections immunology, Bacterial Infections microbiology, Bacterial Infections pathology, Child, Child, Preschool, Common Variable Immunodeficiency complications, Common Variable Immunodeficiency immunology, Common Variable Immunodeficiency microbiology, Common Variable Immunodeficiency pathology, Drug-Related Side Effects and Adverse Reactions, Female, Genetic Diseases, X-Linked complications, Genetic Diseases, X-Linked immunology, Genetic Diseases, X-Linked microbiology, Genetic Diseases, X-Linked pathology, Humans, Immunoglobulin G adverse effects, Immunoglobulin G immunology, Injections, Intravenous, Injections, Subcutaneous, Kinetics, Male, Middle Aged, Prospective Studies, Solutions, Treatment Outcome, United States, Agammaglobulinemia drug therapy, Bacterial Infections drug therapy, Common Variable Immunodeficiency drug therapy, Genetic Diseases, X-Linked drug therapy, Immunoglobulin G administration & dosage
- 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.
- Published
- 2011
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