Table 4 Extended half-life products for treating haemophilia A (FVIII products) Method of TGA status Prophylaxis regimen Product Company half-life recommended in PI (trade/generic name) extension ARTG listings: 278729, 40-50 IU/kg/2 x weekly Baxalta / PEGylation 278728, 278727, 273517 (starting dose 55 IU/kg/2 x BAX-855 (Adynovate) Shire (20kDa) weekly in patients <12 years of age, maximum 70 IU/kg) BAY 81-8973 Bayer Formulated ARTG listings: 236280, Patients >12 years old: 20 – (Kovaltry) Australia with 246793, 246794, 246795, 40 IU/kg 2 or 3 times per Protein 246796 week (HSP) 70 Patients ≤12 years old: 25 – 50 IU/kg 2 or 4 x per week or every other day - BAY 94-9027 Targeted Not TGA registered. Bayer (Damoctocog alfa PEGylation Australia pegol) (60kDa) CSL 627 (Afstyla) CSL Single-chain ARTG listings: 271638, Patients ≥12 years old: 20 – Behring and increased 271637, 271636, 271635, 50 IU/kg/2 or 3 x per week vWF binding 271634, 271633, 270335 Patients <12 years old: 30 – 50 IU/kg/2 or 3 x per week. More frequent or higher doses may be required Not TGA registered. - N8-GP (Turoctocog Novo Alfa Pegol) Nordisk (40kDa) ARTG listings: 210525, 50 IU/kg every 3-5 days or 210524, 210523, 210522, 65 IU/kg/week Bioverativ 210521, 210520, 210519 rFVIII-Fc (Eloctate) Fc Fusion More frequent doses up to Australia 80 IU/kg may be required in children <12 years of age ARTG: Australian Register of Therapeutic Goods; IU = International Units; PI = Product Information; TGA = Therapeutic Goods Administration
Table 4 Extended half-life products for treating haemophilia A (FVIII products) Product (trade/generic name) Company Method of half-life extension TGA status Prophylaxis regimen recommended in PI BAX-855 (Adynovate) Baxalta / Shire PEGylation (20kDa) ARTG listings: 278729, 278728, 278727, 273517 40-50 IU/kg/2 x weekly (starting dose 55 IU/kg/2 x weekly in patients <12 years of age, maximum 70 IU/kg) BAY 81-8973 (Kovaltry) Bayer Australia Formulated with Protein (HSP) 70 ARTG listings: 236280, 246793, 246794, 246795, 246796 Patients >12 years old: 20 – 40 IU/kg 2 or 3 times per week Patients ≤12 years old: 25 – 50 IU/kg 2 or 4 x per week or every other day BAY 94-9027 (Damoctocog alfa pegol) Bayer Australia Targeted PEGylation (60kDa) Not TGA registered. - CSL 627 (Afstyla) CSL Behring Single-chain and increased vWF binding ARTG listings: 271638, 271637, 271636, 271635, 271634, 271633, 270335 Patients ≥12 years old: 20 – 50 IU/kg/2 or 3 x per week Patients <12 years old: 30 – 50 IU/kg/2 or 3 x per week. More frequent or higher doses may be required N8-GP (Turoctocog Alfa Pegol) Novo Nordisk (40kDa) Not TGA registered. - rFVIII-Fc (Eloctate) Bioverativ Australia Fc Fusion ARTG listings: 210525, 210524, 210523, 210522, 210521, 210520, 210519 50 IU/kg every 3-5 days or 65 IU/kg/week More frequent doses up to 80 IU/kg may be required in children <12 years of age ARTG: Australian Register of Therapeutic Goods; IU = International Units; PI = Product Information; TGA = Therapeutic Goods Administration