TABLE 9.
Pharmacokinetic Parameters of Privigen® in Subjects With PI
| 3-Week Dosing Interval (n=3) | 4-Week Dosing Interval (n=22) | |||
|---|---|---|---|---|
| Mean (SD) | Median (Range) | Mean (SD) | Median (Range) | |
| Cmax (peak, mg/dL) | 2,550 (400) | 2,340 (2,290–3,010) | 2,260 (530) | 2,340 (1,040–3,460) |
| Cmin (trough, mg/dL) | 1,230 (230) | 1,200 (1,020–1,470) | 1,000 (200) | 1,000 (580–1,360) |
| t1/2 (days) | 27.6 (5.9) | 27.8 (21.6–33.4) | 45.4 (18.5) | 37.3 (20.6–96.6) |
| AUC0–t (day × mg/dL)* | 32,820 (6,260) | 29,860 (28,580–40,010) | 36,390 (5,950) | 36,670 (19,680–44,340) |
| AUC0–∞ (day × mg/dL)* | 79,315 (20,170) | 78,748 (59,435–99,762) | 104,627 (33,581) | 98,521 (64,803–178,600) |
| Clearance (mL/day/kg) | 1.3 (0.1) | 1.3 (1.1–1.4) | 1.3 (0.3) | 1.3 (0.9–2.1) |
| Mean residence time (days)* | 38.6 (8.1) | 39.5 (30.1–46.2) | 65.2 (24.7) | 59.0 (33.2–129.6) |
| Volume of distribution at steady state (mL/kg)* | 50 (13) | 44 (40–65) | 84 (35) | 87 (40–207) |
Cmax = maximum (peak) serum concentration; Cmin = minimum (trough) serum concentration; t½ = elimination half-life; AUC0-t = area under the curve from 0 hour to last sampling time; AUC0-∞ = area under the curve from 0 hour to infinite time.
*
Calculated by log-linear trapezoidal rule.