Characteristics of EHL CFCs
Brand (nonproprietary name) . | Technology . | Licensed for prophylaxis use . | Manufacturer-recommended starting dose for prophylaxis use* . | Recommended assay for monitoring . |
---|---|---|---|---|
Factor VIII products | ||||
Eloctate®/Elocta® (efmoroctocog alfa) | B-domain deleted FVIII fused to Fc portion of IgG1 | US & EU: all ages | Adults: 50 IU/kg every 4 days; children <6 years: 50 IU/kg twice weekly | One stage or chromogenic |
Adynovate®/Adynovi® (rurioctocog alfa pegol) | Full-length recombinant FVIII with 20 kDa PEG | US: all; EU: ≥12 years | Adolescents/adults: 40-50 IU/kg 2 times weekly; children <12 years: 55 IU/kg 2 times weekly | One stage or chromogenic |
Jivi® (damoctocog alfa pegol) | B-domain deleted FVIII with 60 kDa PEG | US & EU: ≥12 years | 30–40 IU/kg twice weekly | Chromogenic or one stage with validated reagents† |
Esperoct® (turoctocog alfa pegol) | B-domain truncated FVIII with 40 kDa PEG | US: all; EU: ≥12 years | Adolescents/adults: 50 IU/kg every 4 days; children <12 years: 65 IU/kg twice weekly | Chromogenic or one stage with validated reagents† |
Afstyla® (lonoctocog alfa) | Single-chain recombinant FVIII | US & EU: all ages | Adults: 20-50 IU/kg 2-3 times weekly; children <12 years: 30-50 IU/kg 2-3 times weekly | Chromogenic assay |
Factor IX products | ||||
Alprolix® (efrenonacog alfa) | Recombinant FIX fused to Fc portion of IgG1 | US & EU: all ages | Adolescents/adults: 50 IU/kg weekly or 100 IU/kg every 10 days; children <12 years: 60 IU/kg weekly | Chromogenic or one stage with validated reagents† |
Idelvion® (albutrepenonacog alfa) | Recombinant FIX fused to albumin | US & EU: all ages | Adolescents/adults: 25-40 IU/kg weekly; children <12 years: 40-55 IU/kg weekly | One stage with validated reagents† |
Rebinyn®/Refixia® (nonacog beta pegol) | Recombinant FIX with 40 kDa PEG | EU: ≥12 years | 40 IU/kg weekly | Chromogenic or one stage with validated reagents† |
Brand (nonproprietary name) . | Technology . | Licensed for prophylaxis use . | Manufacturer-recommended starting dose for prophylaxis use* . | Recommended assay for monitoring . |
---|---|---|---|---|
Factor VIII products | ||||
Eloctate®/Elocta® (efmoroctocog alfa) | B-domain deleted FVIII fused to Fc portion of IgG1 | US & EU: all ages | Adults: 50 IU/kg every 4 days; children <6 years: 50 IU/kg twice weekly | One stage or chromogenic |
Adynovate®/Adynovi® (rurioctocog alfa pegol) | Full-length recombinant FVIII with 20 kDa PEG | US: all; EU: ≥12 years | Adolescents/adults: 40-50 IU/kg 2 times weekly; children <12 years: 55 IU/kg 2 times weekly | One stage or chromogenic |
Jivi® (damoctocog alfa pegol) | B-domain deleted FVIII with 60 kDa PEG | US & EU: ≥12 years | 30–40 IU/kg twice weekly | Chromogenic or one stage with validated reagents† |
Esperoct® (turoctocog alfa pegol) | B-domain truncated FVIII with 40 kDa PEG | US: all; EU: ≥12 years | Adolescents/adults: 50 IU/kg every 4 days; children <12 years: 65 IU/kg twice weekly | Chromogenic or one stage with validated reagents† |
Afstyla® (lonoctocog alfa) | Single-chain recombinant FVIII | US & EU: all ages | Adults: 20-50 IU/kg 2-3 times weekly; children <12 years: 30-50 IU/kg 2-3 times weekly | Chromogenic assay |
Factor IX products | ||||
Alprolix® (efrenonacog alfa) | Recombinant FIX fused to Fc portion of IgG1 | US & EU: all ages | Adolescents/adults: 50 IU/kg weekly or 100 IU/kg every 10 days; children <12 years: 60 IU/kg weekly | Chromogenic or one stage with validated reagents† |
Idelvion® (albutrepenonacog alfa) | Recombinant FIX fused to albumin | US & EU: all ages | Adolescents/adults: 25-40 IU/kg weekly; children <12 years: 40-55 IU/kg weekly | One stage with validated reagents† |
Rebinyn®/Refixia® (nonacog beta pegol) | Recombinant FIX with 40 kDa PEG | EU: ≥12 years | 40 IU/kg weekly | Chromogenic or one stage with validated reagents† |