ELOCTATE
THE FIRST AND ONLY rFVIII
WITH A PROLONGED HALF-LIFE
5 DAYS WITH
FACTOR LEVELS ABOVE 1%
Mean Plasma FVIII Activity (IU/dL)
MEAN FACTOR ACTIVITY PROFILE
MEAN FACTOR
ACTIVITY
PROFILE
AFTER
A SINGLE
AFTER
A SINGLE
DOSE
(50
IU/kg)†DOSE (50 IU/kg)*
100
50
MEAN TERMINAL HALF-LIFE
AFTER A SINGLE 5O IU/kg
DOSE IN ADULTS*†
10
5
19.7
HOURS
(17.4, 22.0)
ABOVE
1
0
20
40
60
80
Time (Hours)
100
120
Mean terminal half-life after a single 50 IU/kg
dose in pediatric and adolescent patients*†‡
• 16.4 (14.1, 18.6) hours in subjects 12 to 17 (n=11)
• 14.6 (11.5, 17.7) hours in subjects 6 to 11 (n=27)
• 12.0 (9.55, 14.4) hours in subjects 2 to 5 (n=10)
1%
*The pharmacokinetics of ELOCTATE were evaluated following a single dose of
50 IU/kg in the Phase 3 study of 28 adults and 11 adolescent, previously treated
patients (ages 12 to 17 years), and in an open-label, multicenter study of 37
pediatric, previously treated patients (ages 2 to 5 years and 6 to 11 years).
†
Presented in arithmetic mean (95% CI).
‡
Compared to adults and adolescents, clearance was higher in children 2 to 5
years of age, indicating a need for dose adjustme