For adult and adolescent patients, ALPROLIX® prophylaxis offers joint and bleed protection* today with tomorrow in mind
Median joint annualized
spontaneous bleed rate (AsBR) of
- Median joint AsBR of zero with fixed-dose (interval-adjusted) prophylaxis (interquartile range [IQR]: 0.00-1.70)4
- Median joint AsBR of 1.0 with fixed-interval (weekly) prophylaxis (IQR: 0.00-2.10)4
of patients achieved resolution of
target joints✝︎ by switching to ALPROLIX5
- Target joints were resolved for
37/37 patients who had target joints
at the baseline of the B-LONG trial
A target joint is defined as a major joint with ≥3 bleeding episodes in a consecutive 3-month period. The International Society on Thrombosis and Haemostasis subcommittee defines target joint resolution as ≤2 spontaneous bleeds in the target joint over 12 months. Patients had ≥12 months of consecutive follow-up and did not undergo joint surgery within 12 months of the start of follow-up.5,6
Median joint annualized bleed rate (ABR) with ALPROLIX prophylaxis2
- Median joint ABR of 0.36 with fixed-dose (interval-adjusted) prophylaxis (IQR: 0.00-3.24)
- Median joint ABR of 1.11 with fixed-interval (weekly) prophylaxis (IQR: 0.00-4.01)
Median AsBR of ≤1 with ALPROLIX prophylaxis4
- Median AsBR of 0.9 with fixed-dose (interval-adjusted) prophylaxis (IQR: 0.00-2.30)
- Median AsBR of 1.0 with fixed-interval (weekly) prophylaxis (IQR: 0.00-2.20)
84% of adult and adolescent patients experienced pain relief and/or improvement in bleeding with just 1 infusion2
Median overall ABR with ALPROLIX prophylaxis2
- Median overall ABR of 1.38 with fixed-dose (interval-adjusted) prophylaxis (IQR: 0.00-3.43)
- Median overall ABR of 2.95 with fixed-interval (weekly) prophylaxis (IQR: 1.01-4.35)
On-demand treatment with ALPROLIX2
- Median overall ABR of 17.69 (IQR: 10.77-23.24)
- Median AsBR of 11.78 (IQR: 2.62-19.78)
Clinical trial information
B‑LONG studied 123 previously treated adult and adolescent males for a total of 77 weeks. Patients were enrolled in a fixed‑interval (weekly) prophylaxis arm (n=63), a fixed‑dose (interval‑adjusted) arm (n=29), an on‑demand arm (n=27), or a perioperative arm (n=12).2
B‑YOND included 23 pediatric and 93 adult and adolescent patients who previously completed Kids B‑LONG or B‑LONG. The treatment arms included fixed‑interval (weekly) prophylaxis, fixed‑dose (interval‑adjusted) prophylaxis, modified prophylaxis, and on‑demand (episodic) treatment.3See more clinical trial details
Important Safety Information
CONTRAINDICATIONS: ALPROLIX® is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.
WARNINGS AND PRECAUTIONS: Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with factor replacement therapies, and have been reported with ALPROLIX. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.
Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX, including in previously untreated patients. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor IX levels have been achieved and maintained.
The use of Factor IX products has been associated with the development of thromboembolic complications.
Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. The safety and efficacy of using ALPROLIX for immune tolerance induction have not been established.
ADVERSE REACTIONS: Common adverse reactions (incidence ≥1%) observed in clinical trials were headache, oral paresthesia, and obstructive uropathy.
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes
Please see Full Prescribing Information.
References: 1. Fischer K, Kulkarni R, Nolan B, et al. Recombinant factor IX Fc fusion protein in children with haemophilia B (Kids B-LONG): results from a multicentre, non-randomised phase 3 study. Lancet Haematol. 2017;4:e75-e82. 2. ALPROLIX® [package insert]. Waltham, MA: Bioverativ®, a Sanofi Company; 2018. 3. 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;117:508-518. 4. 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. 5. Data on file. Bioverativ Therapeutics Inc., an affiliate of Sanofi. 6. Blanchette VS, Key NS, Ljung LR, Manco-Johnson MJ, van den Berg HM, Srivastava A. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12:1935-1939. 7. Iorio A, Fischer K, Blanchette V, et al. Tailoring treatment of haemophilia B: accounting for the distribution and clearance of standard and extended half-life FIX concentrates. Thromb Haemost. 2017;117(6):1023-1030. 8. Diao L, Li S, Ludden T, Gobburu J, Nestorov I, Jiang H. Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B. Clin Pharmacokinet. 2014;53:467-477. 9. Björkman S. Population pharmacokinetics of recombinant factor IX: implications for dose tailoring. Haemophilia. 2013;19:753‐757. 10. IDELVION® [package insert]. Marburg, Germany: CSL Behring GmbH; 2017. 11. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2017. 12. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc; 2017. 13. Ixinity® [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2016. 14. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2016. 15. Profilnine® [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2013. 16. Rixubis® [package insert]. Westlake Village, CA: Baxalta US Inc; 2016. 17. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017. 18. 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(suppl):1-14. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1305074/suppl_file/nejmoa1305074_appendix.pdf. Accessed May 2, 2018. 19. Powell J, Shapiro A, Ragni M, et al. Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates. Br J Haematol. 2015;168:113-123. 20. Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313:670-673. 21. Shapiro A. Development of long-acting recombinant FVIII and FIX Fc fusion proteins for the management of hemophilia. Expert Opin Biol Ther. 2013;13(9):1287-1297. 22. National Hemophilia Foundation. Digital Hemophilia Treatment Center Monitoring Linked to Significant Reduction in Bleeding Rates. https://www.hemophilia.org/Newsroom/Medical-News/Digital-Hemophilia-Treatment-Center-Monitoring-Linked-to-Significant-Reduction-in-Bleeding-Rates. Accessed June 7, 2018.