Table 1.
Pharmacokinetic profile of single intravenous lonoctocog alfa doses of 50 IU/kg in previously treated patients with severe haemophilia A
| Parameter (units) | Adults [12, 13] 18 to ≤65 years (n = 81) |
Adolescents [12, 13] 12 to <18 years (n = 10) |
Children [8] | |
|---|---|---|---|---|
| 6 to <12 years (n = 19) | 0 to <6 years (n = 20) | |||
| AUC∞ (IU·h/dL) | 1960 | 1540 | 1170 | 1080 |
| CL (mL/h/kg) | 2.90 | 3.80 | 4.63 | 5.07 |
| Cmax (IU/dL) | 106.0 | 89.70 | 83.50 | 80.20 |
| IR (IU/dL per IU/kg) | 2.00 | 1.69 | 1.66 | 1.60 |
| MRT (h) | 20.40 | 20.00 | 12.30 | 12.40 |
| t1/2 (h) | 14.20 | 14.30 | 10.20 | 10.40 |
| Vss (mL/kg) | 55.2 | 68.50 | 67.10 | 71.00 |
FVIII activity assessed using a chromogenic substrate assay; all values are means
AUC ∞ area under the FVIII activity-time curve extrapolated to infinity, CL clearance, C max maximum concentration, FVIII factor VIII, IR incremental recovery, MRT mean residence time, t 1/2 elimination half-life, Vss volume of distribution at steady state