On-demand dosing with ALPROLIX® can be used to control your patients' bleeding episodes1
Pediatric and adult/adolescent dosing targets for on-demand treatment and control of bleeding episodes1
Type of bleed
Target circulating factor IX
(IU/dL or %
of normal)
Dosing interval
Minor and moderatea
30-60
Repeat every 48 hours if there is further evidence of bleeding
Majorb
80-100
Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days.
Due to the long half-life of ALPROLIX, the dose may be reduced, and the frequency of dosing may be extended after Day 3 to every 48 hours or longer until bleeding stops and healing is achieved
aMinor and moderate bleed events. For example: uncomplicated hemarthroses, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucous membranes.
bMajor bleed events. For example: iliopsoas and deep muscle with neurovascular injury or substantial blood loss; pharyngeal; retropharyngeal; retroperitoneal; CNS.
Nearly half (47%) of the adults and adolescents
who were treated with ALPROLIX on-demand during
B-LONG (n=19)
switched to ALPROLIX prophylaxis during the
B-YOND extension trial2
Clinical trial information
B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 123 previously treated adult and adolescent patients aged ≥12 years with severe hemophilia B. The study included a fixed-interval (weekly) arm (n=63), a fixed-dose (interval-adjusted) arm (n=29), an episodic (on-demand) arm (n=27), and a surgical arm (n=12).1
B-YOND was an extension trial that studied the long-term safety and efficacy of ALPROLIX in 120 adult, adolescent, and pediatric patients previously treated in Kids B-LONG or B-LONG. The study included a fixed-interval arm (n=74), a fixed-dose arm (n=36), a modified prophylaxis arm (n=17), and an episodic (on-demand) arm (n=15).3
Peak activity level
ALPROLIX reaches peak activity in 10 minutes
—as quickly as BeneFIX® [coagulation factor IX (recombinant)]4,5*†
Studies have not been conducted to assess the safety or
efficacy of ALPROLIX compared with BeneFIX.
*A subset of 22 patients (the sequential pharmacokinetic subgroup) received consecutive single IV doses of 50 IU/kg BeneFIX and ALPROLIX at the beginning of the B-LONG study (baseline) for direct comparison. For both ALPROLIX and BeneFIX, peak activity was reached approximately 10 minutes after the start of the infusion.4,5
†Peak activity level does not mean bleeds are resolved within 10 minutes.4
With the widest range of vial strengths in hemophilia B,
ALPROLIX offers the potential to resolve bleeds with fewer
vials1,6-11