Page 10 - HFA_Dateline_2017_Q2_Fall_Special_Edition

Current Products | Factor VIII

VIII Recombinant Clotting Factor

Manufacturer Product Type Half Life FDA Approved

Bayer Kogenate FS Recombinant Clotting Factor 13 hours 1993

Bayer Kovaltry Recombinant Clotting Factor 0 to <6 yrs: 12 hours 2016
6 to <12 yrs: 12 hours
12 to 17 yrs: 14 hours
>18 yrs: 14 hours

Bioverativ Eloctate Recombinant Clotting Factor 19.7 hours (17.4, 22.0) in adults 2014
Pediatric: 12 to 17 years: 16.4 hours (14.1, 18.6)
6 to 11 years: 14.9 hours (12.0, 17.8)
1 to 5 years: 12.7 hours (11.2, 14.1)

CSL Behring Helixate FS* Recombinant Clotting Factor Adults: 13.7-14.6 hours (mean) 1993
CSL Behring Afstyla Recombinant Clotting Factor Children: 10.7 hours (mean)

After single dose of 50 IU/kg: 2016
Adults (>18 years): 14.2 hours (mean);
Adolescents (>12 to <18 years): 14.3 hours (mean);
Children: (0 to <6 yrs): 10.4 hours (mean);
(>6 to <12 years): 10.2 hours (mean)

Novo Nordisk Novoeight Recombinant Clotting Factor 2013
Octapharma Nuwiq Recombinant Clotting Factor
17.1 +/- 11.2hrs. (Adults); 13.1 +/- 2.6hrs. 2015
(6-<12 yrs.); 11.9 +/- 5.4hrs. (2-5 yrs.)

Pfizer Xyntha Recombinant Clotting Factor 11.2 ± 5.0 hoursa,b 2008

Pfizer Xyntha Solofuse Recombinant Clotting Factor 11.2 ± 5.0 hoursa,b 2008

Shire Recombinate Recombinant Clotting Factor 14.6 hrs 1992
Shire Advate Recombinant Clotting Factor 12.03 hrs 2003
Shire Adynovate Recombinant Clotting Factor 14.69 hours (patients over 18 years old) 1.3-1.5 2015
half-life extension compared to ADVATE

10 Dateline Federation | Special Issue Fall 2017