Page 13 - HFA_Dateline_2019_Q1_Spring_SpecialEdition

FDA Approved Indications (FVIII,FIX,vWD, Inh, etc) Notes
2018 VIII (Age 12 and older) Extended half life
1993 VIII
2016 VIII

2014 VIII

2016 VIII

1993 VIII Supply will continue to be available through early 2019.
2013
For use in adults and children with hemophilia
A for:
• Control and prevention of bleeding
• Perioperative management
• Routine prophylaxis to prevent or reduce the
frequency of bleeding episodes.

Novoeight® is not indicated for the treatment of
von Willebrand disease.

2015 Indicated in adults and children with NUWIQ is a recombinant FVIII Produced in Human Cells
2008 hemophilia A for on-demand treatment and without Chemical Modication or Protein Fusion.
2008 control of bleeding episodes, perioperative
(surgical) management of bleeding and routine
prophylaxis to reduce the frequency of
bleeding episodes. *Not for vWD

VIII a-Results from 30 previously-treated patients 12 to 60 years
old, who received a single infusion of 50 IU/kg. b-Compared
to adults, the half-life is shorter in children and the clearance
(based on per kg body weight) is approximately 40% higher
in children.

VIII a-Results from 30 previously-treated patients 12 to 60
years old, who received a single infusion of 50 IU/kg XYNTHA.
b-Compared to adults, the half-life of XYNTHA is shorter in
children and the clearance (based on per kg body weight) is
approximately 40% higher in children.

Special Issue 2018-19 | Dateline Federation 13