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

@article{Wasserman2011EfficacySA,
  title={Efficacy, Safety, and Pharmacokinetics of a 10% Liquid Immune Globulin Preparation (GAMMAGARD LIQUID, 10%) Administered Subcutaneously in Subjects with Primary Immunodeficiency Disease},
  author={Richard L. Wasserman and Isaac Melamed and Lisa J. Kobrynski and Steven D. Strausbaugh and Mark R. Stein and Marlies Sharkhawy and Werner Engl and Heinz Leibl and Luba Sobolevsky and David M Gelmont and Richard I. Schiff and William J. Grossman},
  journal={Journal of Clinical Immunology},
  year={2011},
  volume={31},
  pages={323-331}
}
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… CONTINUE READING

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