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) | (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.
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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
Indication
References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B. Thromb Haemost. 2017;117(3):508-518. 3. Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: results from the B-YOND extension study. Haemophilia. 2020;26(6):e262-e271. 4. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 5. Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323. 6. Idelvion® [package insert]. Marburg, Germany: CSL Behring GmbH; 2021. 7. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2022. 8. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc.; 2021. 9. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; 2021. 10. Ixinity® [package insert]. Seattle, WA: Aptevo BioTherapeutics LLC; 2022. 11. Rixubis® [package insert]. Lexington, MA: Baxalta US Inc.; 2020.
