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 a flexible factor IX treatment that can keep your on-demand patients protected, regardless of how their needs change over time2

Patients with hemophilia B may adjust their management approach over time to fit their needs21

Nearly half of the patients treated with ALPROLIX on demand during B-LONG (n=19) switched to ALPROLIX prophylaxis during the B-YOND extension trial3

ALPROLIX is the #1 prescribed EHL factor IX product for on-demand treatment5*

Adult and pediatric dosing for on-demand treatment and control of bleeding episodes2
Type of bleedMinor and moderateaMajorb
Target circulating factor IX (IU/dL or % of normal)30-6080-100
Dosing interval (hours)Repeat every 48 hours if there is further evidence of bleedingConsider a repeat dose after 6 to 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

For your on-demand patients, ALPROLIX offers effective bleed control2

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90% of bleeding episodes (n=575/636) were resolved with just 1 infusion

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8 in 10 patients reported abrupt or definite pain relief and/or improvement in signs of bleeding with just 1 infusion

In B-LONG, the median overall ABR for adults and adolescents treating on demand was 17.69 (10.77-23.24)

84% of patients reported "excellent" or "good" response to the first injection. "Excellent" response was defined as abrupt pain relief and/or improvement in signs of bleeding. "Good" response was defined as definite pain relief and/or improvement in signs of bleeding but possibly requiring another injection in 1-2 days.

See the

ABR=annualized bleed rate; EHL=extended half-life.

*Based on data from hemophilia treatment centers as of June 2019.


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.


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.