Skip to main content
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] logo
mobile_Layer-Comp-12

For your patients with hemophilia B, trusted bleed protection* every step of the way1,2


10 year

Switch to ALPROLIX, the first FDA-approved EHL, approved since 20141,3

ALPROLIX has more than 10 years of experience with hemophilia B patients across ages and settings1-3

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, and 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.
See Important Safety Information below.

Trusted protection*

Bleed protection* across all age groups1,2

Extended dosing

Help reduce patient treatment burden1,4†

Real-world experience

Observed results in switches from SHLs4,5

Demonstrated safety

Across ages and settings1

Learn more about copay assistance‡

*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1
ALPROLIX prophylaxis provides comparable or reduced number of injections vs SHLs, which may help reduce treatment burden for patients.1,4
Terms and conditions apply.
EHL=extended half-life; SHL=standard half-life.

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.

INDICATION:

IMPORTANT SAFETY INFORMATION

References: 1. ALPROLIX. Package insert. Bioverativ Therapeutics Inc; 2023. 2. 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. 3. Graf L. Extended half-life factor VIII and factor IX preparations. Transfus Med Hemother. 2018;45(2):86-91. 4. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 5. Shapiro A, Chaudhury A, Wang M, et al. Real-world data demonstrate improved bleed control and extended dosing intervals for patients with haemophilia B after switching to recombinant factor IX Fc fusion protein (rFIXFc) for up to 5 years. Haemophilia. 2020;26(6):975-983.

© 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-2021399-v8.0-10/2025 Last updated: October 2025