Table 3.
Pharmacokinetic Parameters of Berinert® in Adult Subjects with HAE by Non-compartmental Analysis (n=35)
| Parameters | Unadjusted for baseline | Adjusted for baseline |
|---|---|---|
| AUC(0-t) (hr x IU/mL)* | 27.5 ± 8.5 (15.7–44.7) | 12.8 ± 6.7 (3.9–34.7) |
| CL (mL/hr/kg) | 0.60 ± 0.17 (0.34–0.96) | 1.44 ± 0.67 (0.43–3.85) |
| Vss (mL/kg) | 18.6 ± 4.9 (11.1–27.6) | 35.4 ± 10.5 (14.1–56.1) |
| Half-life (hrs) | 21.9 ± 1.7 (16.5–24.4) | 18.4 ± 3.5 (7.4–22.8) |
| MRT (hrs) | 31.5 ± 2.4 (23.7–35.2) | 26.4 ± 5.0 (10.7–33.0) |
AUC=area under the curve; CL=clearance; MRT=mean residence time; Vss,=volume steady state
*
Based on a 15 unit/kg dose. Numbers in parentheses are the range.
Source: Berinert® Prescribing Information 2009.