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- W2015504328 abstract "RATIONALE: To compare total IgG area under the curve (AUC) following IV and SC administration, with the aim to show pharmacokinetics (PK) equivalence of a new 10% IGSC product. METHODS: A multi-center, prospective, open label study evaluated pharmacokinetics, efficacy, and safety ofIGSC 10% given IV and SC to subjects with PIDD. The dose of IGSC was adjusted during the study to obtain AUCSC that was comparable to the AUCIV. Bioavailability was evaluated as IgG-AUC for subjects ≥ 12 years old and as IgG trough levels for subjects age 2 to < 12 years old. IgG trough level assessments were used to individualize dosing. RESULTS: A dose adjustment factor of 137% was determined to obtain equivalent AUCIV and AUCSC. The target serum IgG trough level on weekly IGSC treatment was 1.28 times (range: 1.13 - 1.43) the last IGIV trough level. Median IgG trough levels at the end of the study were 1250 mg/dL. CONCLUSION: IGSC therapy at a dosing factor of 1.37 resulted in equivalent bioavailability to IV administration. This adjustment factor was similar to that found in a study with a 16% SC product, but was lower than the adjustment factor found in a study with a 20% SC product (1.52). The trough levels achieved were above the suggested protective range." @default.
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- W2015504328 date "2011-02-01" @default.
- W2015504328 modified "2023-10-14" @default.
- W2015504328 title "Pharmacokinetic Analysis (PK) of Immune Globulin Subcutaneous (Human), 10% (IGSC) Administered Intravenously or Subcutaneously in Subjects with Primary Immunodeficiency Diseases (PIDD)" @default.
- W2015504328 doi "https://doi.org/10.1016/j.jaci.2010.12.077" @default.
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