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About Factor IX
Adult & Adolescent Efficacy
Dosing
Safety
Mechanism of Extension
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Mechanism of Extension

ALPROLIX is the only factor IX product to utilize half-life extension with Fc Fusion technology1-3

  • ALPROLIX is composed of rFIX covalently linked to the Fc region of IgG11,4
    • IgG1 is a naturally occurring protein with anti-inflammatory properties1,4
    • The natural recycling pathway of IgG1 allows ALPROLIX to stay in the body for an extended period of time, delaying degradation and extending half life1
    • ALPROLIX does not accumulate in the body5

ALPROLIX is the only EHL to mimic the pathway of natural factor IX, going to where it is needed2,6

 

ALPROLIX mirrors the pathway of natural FIX by leaving the bloodstream and distributing in the extravascular space1,2

pathway structure

ALPROLIX uses Fc Fusion to extend the period of time it remains in the body vs BeneFIX®1,6

 

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ALPROLIX reaches peak activity in 10 minutes—as quickly as BeneFIX [coagulation factor IX (recombinant)]6*†

2.4X

ALPROLIX stays in circulation more than twice as long as BeneFIX6

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The half life of ALPROLIX was 82 hours vs 34 hours for BeneFIX6

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.6,7
† Peak activity level does not mean bleeds are resolved within 10 minutes.6
EHL=extended half-life; FIX=factor IX; IgG1=immunoglobulin G1; rFIX=recombinant factor IX.

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INDICATION:

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.

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. 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:

The most common adverse reactions (incidence ≥1%) in previously untreated patients were injection site erythema, hypersensitivity, and Factor IX inhibition. The most common adverse reactions (incidence ≥1%) in previously treated patients were headache, oral paresthesia, and obstructive uropathy.

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INDICATION:

IMPORTANT SAFETY INFORMATION

References: 1. ALPROLIX. Package insert. Bioverativ Therapeutics Inc; 2023. 2. Iorio A, Fischer K, Blanchette V, Rangarajan S, Young G, Morfini M; Pharmacokinetic (PK) Expert Working Group of the International Prophylaxis Study Group (the IPSG). 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. 3. 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. 4. Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313(5787):670-673. 5. 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. 6. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 7. Powell JS, Pasi KJ, Ragni MV, et al; B-LONG Investigators. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.

©2025 Sanofi. All rights reserved. ALPROLIX, Sanofi, and HemAssist are trademarks or registered trademarks of Sanofi or an affiliate. All the other trademarks above are the property of their respective owners, who have no affiliation or relationship with Sanofi. MAT-US-2021402-v9.0-11/2025 Last updated: November 2025

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