^aRebinyn^® achieved and maintained higher factor levels than recombinant Factor 9 based upon a phase 1 study comparing 25, 50, and 100 IU/kg single doses of Rebinyn^® to a 50 IU/kg single dose of standard half-life recombinant Factor 9 in 7 adults and a 50 IU/kg dose of plasma-derived Factor 9 in 8 adults. For Rebinyn^®, estimated average Factor 9 activity is adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR₃₀) and half-life were higher and longer with Rebinyn^® than recombinant Factor 9 (IR₃₀ 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs 19 hours). The clinical relevance of these pharmacokinetic differences is unknown. Incremental recovery is the increase in plasma concentration per IU/kg of factor administered. Half-life is the time it takes for the level of factor in the blood to fall by half (50%).

^bWFH offers guidelines that inform shared decision-making between patients, caregivers, and healthcare providers based on data from existing peer-reviewed findings.

^cData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking repeated doses of Rebinyn^® 40 IU/kg once weekly. Factor 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).

^dBased on the mean steady-state post-dose peak levels and pre-dose trough levels 168 hours after administered Rebinyn^® 40 IU/kg once weekly in previously treated patients (20 adult and 9 adolescent patients). 

^eHalf-life: Time required for Factor 9 to decline to half its value.

^fBased on analysis using a 1-stage assay in patients (n=6) aged 18 and older, the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing; in patients (n=3) aged 13 to 17, the half-life at steady state was 103 hours. Following single-dose administration (40 IU/kg) in the same patient population, the half-life was 83 hours (adults) and 89 hours (adolescents).