ABR=annualized bleed rate.
d50 IU/kg every 4 days. Regimen can be individually tailored to less or more frequent dosing based on bleeding episodes.12
eIn a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in PTPs aged ≥12 years with severe hemophilia A. Single-dose PK studies were performed in 42 adults after receiving Esperoct® 50 IU/kg; 175 PTPs received routine prophylaxis (50 IU/kg Q4D) for 76 weeks and 12 adults elected to be treated on demand during the main phase. Treatment-requiring bleeds were reported by patients through diaries. Mean trough levels for adults (age ≥18 years) were 3.0 IU/dL and for adolescents (12 to less than 18 years) were 2.7 IU/dL.12,13