Table 1.
Parameter | Intravenous IGIV-C (n = 32) | Subcutaneous IGIV-C (n = 26) |
---|---|---|
AUC0-τ, mg h/ml, mean | 7640 | 6858† |
Cmax, mg/ml, mean ± s.d. | 21·1 ± 3·9 | 12·2 ± 2·4 |
Ctrough, mg/ml, mean ± s.d. | 9·6 ± 2·1‡ | 11·4 ± 2·3§ |
Cave, mg/ml, mean ± s.d. | n.d. | 11·6 ± 2·4 |
tmax, h, mean ± s.d. | 2·9 ± 1·1 | 55·0 ± 48·6 |
t1/2, h, mean ± s.d. | 735·5 ± 138·5 | n.d.¶ |
Data are reported for the pharmacokinetic population, with the exception of Ctrough data (IgG population).
Adjusted steady-state AUC based on intravenous dosing schedule (every 3 versus 4 weeks).
Mean Ctrough for intravenous IGIV-C was calculated from data for two intravenous infusions.
Mean Ctrough for subcutaneous IGIV-C was calculated from data for weeks 13, 17, 18, 19 and 21 for 28 patients (all patients who received study medication and had Ctrough data).
Not determined because of relatively constant plasma concentrations over 7-day dosing interval. AUC0-τ, area under the concentration-versus-time curve over the dosing interval; Cave, mean steady-state IgG concentration; Cmax, maximum observed IgG concentration; Ctrough, trough (predose) plasma IgG concentration; IgG, immunoglobulin G; IGIV-C, immune globulin intravenous (human), 10% caprylate/chromatography purified; n.d., not determined; PIDD, primary immunodeficiency disease; s.d., standard deviation; t1/2, apparent elimination half-life; tmax, time to Cmax.