Page 34 - HFA Dateline 2022 Special Edition

CURRENT PRODUCTS

Factor VIII

FDA INDICATIONS/
THERAPY NAME MANUFACTURER THERAPY TYPE SPECIFIC THERAPY TYPE HALF-LIFE APPROVAL TARGET NOTES

Xyntha Pfizer Recombinant clotting factor Coagulation Factor VIII 11.2 ± 5.0 hours1,2 2008 Factor VIII 1-Results from 30 previously treated
(recombinant) patients(PTPs) 12 to 60 years old, who
received a single infusion of 50 IU/kg
XYNTHA. 2-Compared to adults, the half-
life of XYNTHA is shorter in children and the
clearance (based on per kg body weight) is
approximate. Prescribing Information at www.
pfizermedicalinformation.com/en-us/patient

Xyntha Solofuse Pfizer Recombinant clotting factor Coagulation Factor VIII 11.2 ± 5.0 hours1,2 2008 Factor VIII 1-Results from 30 previously treated
(recombinant) patients(PTPs) 12 to 60 years old, who
received a single infusion of 50 IU/kg
XYNTHA. 2-Compared to adults, the half-
life of XYNTHA is shorter in children and the
clearance (based on per kg body weight) is
approximate. Prescribing Information at www.
pfizermedicalinformation.com/en-us/patient

Factor IX

FDA INDICATIONS/
THERAPY NAME MANUFACTURER THERAPY TYPE SPECIFIC THERAPY TYPE HALF-LIFE APPROVAL TARGET NOTES

Alphanine SD Grifols Plasma-derived clotting factor 1990 Factor IX

Alprolix Sanofi Recombinant clotting factor Antihemophilic factor (recombinant), 50 IU/KG: Adults - 86.52 Hrs (37.2%) 2014 Factor IX
Fc fusion protein Pediatric - 12 to 17 years: 80 hours (15%);
6 to 11 years: 72 hours (23%); 2 to 5 years:
68 hours (24%) 100 IU/KG: Adults - 97
Hrs (35%) Pediatric - 12 to 17 years: 94
hours (24%)

BeneFIX Pfizer Recombinant clotting factor Coagulation Factor IX (recombinant) 18.8 ± 5.4 hours (range 11 to 36 hours) 1,2 1997 Factor IX 1-Results from 37 previously treated adult
patients (>15 years old) after single intravenous
dose of 50 IU/kg BeneFIX given as a 10-minute
infusion. 2-The mean ± standard deviation t / 2
1
in 13 children aged ≥ 2 years to <12 years and 6
adolescents aged ≥1

Cyklokapron Pfizer Non-factor product Antifibrinolytic agent 2 hours 1 1986 Factor VIII; 1-terminal elimination phase 2-indicated in
(tranexamic Factor IX patients with hemophilia for short-term use (two
acid injection) to eight days) to reduce or prevent hemorrhage
and reduce the need for replacement therapy
during and following tooth extraction

34 DATELINE FEDERATION < www.hemophiliafed.org