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Table 6 Pharmacokinetic parameters for the IGSC 20 % and IGIV 10 % treatments

From: Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Treatment Perioda (IP) Period 1 (IGIV 10 %) Period 2 (IGSC 20 %, 145 % of IGIV 10 %) Period 4 (IGSC 20 %, individualized)
Dosing interval 3 weeks (n = 16) 4 weeks (n = 38) 1 week (n = 18) 1 week (n = 60)
Parameter [unit] Geom. mean 95 % CI Geom. mean 95 % CI Geom. mean 95 % CI Geom. mean 95 % CI
AUC (g/days/l) 352.05 319.74–387.63 410.40 381.24–441.79 108.33 97.60–120.24 115.21 109.23–121.52
AUC / (Dose/Weight) [(g/days/l)/(g/kg)] 606.99 495.29–743.87 796.30 715.36–886.40 472.50 411.07–543.10 536.05 495.58–579.82
Clearanceb [ml/kg/days] 1.65 1.34–2.02 1.26 1.13–1.40 2.12 1.84–2.43 1.87 1.72–2.02
Cmax (g/l) 27.09 24.30–30.19 24.85 23.18–26.64 17.31 15.11–19.82 19.31 18.13–20.57
Tmax (h) 6.94 3.96–12.17 5.84 3.62–9.40 54.19 36.28–80.92 78.68 65.37–94.70
Cmin (g/l) 12.03 10.64–13.60 10.37 9.50–11.33 13.85 12.61–15.21 14.00 13.14–14.91
  1. 95 %CI 95 % confidence interval
  2. aPeriod 1 and period 2 data includes patients aged 12 years and older; period 4 data includes patients aged 2 years and older.
  3. bApparent clearance for SC administration