WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B. View full indications and usage.

ALPROLIX® is the only factor IX product to offer a natural pathway for half-life extension with Fc Fusion technology

ALPROLIX is comprised of rFIX covalently linked to the Fc region of IgG12

Factor IX is covalently linked to the Fc domain of IgG1
  • The natural recycling pathway of IgG1 allows ALPROLIX to stay in circulation longer. IgG1 is a protein with anti-inflammatory properties8
  • ALPROLIX binds to the neonatal Fc receptor, which distributes throughout the body and diverts ALPROLIX to delay degradation and extend half-life2
  • ALPROLIX degrades naturally into amino acids and does not accumulate in the body2,9

ALPROLIX reaches its peak activity level
 as quickly as BeneFIX—within
 10 minutes of infusion5*

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 study (baseline) for direct comparison. For both ALPROLIX and BeneFIX, peak activity was reached approximately 10 minutes after the start of the infusion.

Experience Fc Fusion technology in action

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.

INDICATIONS:

ALPROLIX® is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

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(2):e75-e82. 2. ALPROLIX [package insert]. Waltham, MA: Bioverativ; 2019. 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(3):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. Waltham, MA; Bioverativ Therapeutics Inc. 6. Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12(11):1935-1939. 7. Shapiro AD, Pasi KJ, Ozelo MC, et al. Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B. Res Pract Thromb Haemost. 2018;3(1):109-113. 8. Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313(5787):670-673. 9. 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. 10. 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. 11. 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(5):467-477. 12. Björkman S. Population pharmacokinetics of recombinant factor IX: implications for dose tailoring. Haemophilia. 2013;19(5):753‐757. 13. IDELVION® [package insert]. Marburg, Germany: CSL Behring GmbH; 2019. 14. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals LLC; 2018. 15. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc; 2019. 16. Ixinity® [package insert]. Seattle, WA: Aptevo BioTherapeutics LLC; 2018. 17. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2018. 18. Profilnine® [package insert]. Los Angeles, CA: Grifols Biologicals LLC; 2018. 19. Rixubis® [package insert]. Lexington, MA: Baxalta US Inc; 2018. 20. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017. 21. Baumann K, Hernandez G, Witkop, M, et al. Impact of mild to severe hemophilia on engagement in recreational activities by US men, women, and children with hemophilia B: The Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study. Eur J Haematol. 2017;98:25-34.