FVIII activity vs time profile for rFVIIIFc and rFVIII, 50 IU/kg intravenous injection. Data presented are observed FVIII activity (mean ± standard error) for each treatment group at nominal times. Dashed lines indicate 1 IU/dL (1%) and 3 IU/dL (3%) trough levels. Pharmacokinetic (PK) parameters were assessed after the first dose of rFVIII or rFVIIIFc for 28 evaluable subjects with data available for both rFVIIIFc and rFVIII. The terminal half-life of rFVIIIFc was significantly longer than that of rFVIII (geometric mean: 19.0 vs 12.4 hours, respectively; P < .001). Clearance (95% CI) was significantly lower for rFVIIIFc (2.0 [1.7-2.2] mL/h/kg) vs rFVIII (3.0 [2.7-3.4] mL/h/kg); P < .001. Dose-normalized area under the curve (95% CI) was 51.2 (45.0-58.4) and 32.9 (29.3-36.9) IU × h/dL per IU/kg for rFVIIIFc and rFVIII, respectively (P < .001). Times to 1 and 3 IU/dL above baseline (95% CI) were 4.9 (4.4-5.5) and 3.7 (3.3-4.1) days for rFVIIIFc vs 3.3 (3.0-3.7) and 2.5 (2.2-2.7) days for rFVIII, respectively (P < .001). h, hours.