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DosingRecommended dose modificationsDose Administration

Heritage

BeneFIX® was the first rFIX product licensed for patients with hemophilia B11 and it represents more than 20 years of commitment to innovation and improvement of outcomes for your patients.1,12*
 

 Milestones in Hemophilia Care  Experience  

Committed to the hemophilia B community for more than 20 years13,*

  

Complex Protein Production

   

   

Established cell line shown to be free of foreign agents and capable of producing large amounts of rFIX in an albumin-free medium.14,15

   

Advanced Purification

   

   

   

Customized purification processes designed with viral safety in mind.14,15

  

Quality Validation

  

   

Over 150 quality control examinations are performed on each batch of BeneFIX® to help ensure a consistent purification process.16

  

BeneFIX® was the first rFIX product licensed for the treatment of Hemophilia B.10,17
  • BeneFIX® demonstrates a favourable safety profile in the treatment of hemophilia B.17

The use of BeneFIX® in hemophilia B is supported by clinical trials and more than 20 years of clinical experience.10,13,17-20

  • Demonstrates efficacy in PTPs and PUPs18,19
  • Shows hemostatic efficacy in paediatric patients when used prophylactically17 
  • Achieves good efficacy through adequate dosing and monitoring10 
  • Has an inhibitor profile comparable to other FIX treatments10,18,19
  *BeneFIX® was first approved for use by the EMA in 1997.13

       

AF-CC, albumin-free cell culture; EHL, Extended half-life; FIX, factor IX; FVIII, factor VIII; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PTPs, previously treated patients; PUPs, previously untreated patients; rFIX, recombinant factor IX.


References: Local product document, Nonacog alfa (recombinant coagulation factor IX), BeneFIX® : LPDBEN062022.Kelley B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2010;16(5):717-725. Key NS, Negrier C. Coagulation factor concentrates: past, present, and future. Lancet. 2007;370(9585):439-448.Lusher JM. 50 years in hematology. ASH. Accessed May 2, 2022. https://www.ema.europa.eu/en/documents/product-information/refacto-af-epar-product-information_en.pdf.ReFacto AF. Summary of product characteristics. Pfizer. Accessed May 2, 2022. https://www.ema.europa.eu/en/documents/product-information/refacto-af-epar-product-information_en.pdf.Wyeth receives FDA approval for new BeneFIX features that provide hemophilia B patients a simpler and more convenient preparation process for recombinant factor IX. BioSpace. Accessed May 2, 2022. https://www.biospace.com/article/releases/wyeth-receives-fda-approval-for-new-benefix-features-that-provide-hemophilia-b-patients-a-simpler-and-more-convenient-preparation-process-for-recombin.Colvin BT, Astermark J, Fischer K, et al. European principles of haemophilia care. Haemophilia. 2008;14(2):361-374.Mannucci PM. Hemophilia therapy: the future has begun. Haematologica. 2020;105(3):545-553. Lillicrap D. Bispecific antibody therapy in haemophilia. N Engl J Med. 2017;377(9):884-885.Lambert T, Recht M, Valentino LA, et al. Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B. Haemophilia. 2007;13(3):233-243.Evidence-based clinical practice guidelines for the use of recombinant and plasma-derived FVIII and FIX products. Australian Health Ministers’ Advisory Council. Accessed May 2, 2022. https://www.blood.gov.au/system/files/documents/fviii-fix-guidelines.pdfLivnat T, Martinowitz U, Zivelin A, Seligsohn U. Effects of factor VIII inhibitor bypassing activity (FEIBA), recombinant factor VIIa or both on thrombin generation in normal and haemophilia A plasma. Haemophilia. 2008;14(4):782-786.CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. February 11, 1997. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. Accessed May 2,2022. https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htmAdamson S, Charlebois T, O'Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35(2 Suppl 2):22-27.Harrison S, Adamson S, Bonam D, et al. The manufacturing process for recombinant factor IX. Semin Hematol. 1998;35(2 Suppl 2):4-10. Edwards J, Kirby N. Recombinant coagulation factor IX (BeneFIX). In: Walsh G, Murphy B, eds. Biopharmaceuticals, an Industrial Perspective. Kluwer Academic Publishers; 1999:73-108.Monahan PE, Liesner R, Sullivan ST, Ramirez ME, Kelly P, Roth DA. Safety and efficacy of investigator-prescribed BeneFIX prophylaxis in children less than 6 years of age with severe haemophilia B. Haemophilia. 2010;16(3):460-468. Shapiro AD, Di Paola J, Cohen A, et al. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood. 2005;105(2):518-525.Roth DA, Kessler CM, Pasi KJ, et al. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood. 2001;98(13):3600-3606. Ragni MV, Pasi KJ, White GC, et al. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8(2):91-97.  

PP-BEN-IND-0038 June 2023

About


Dosing

BeneFIX® provides dosing options based on individual needs

Learn more


Efficacy and Safety

Proven efficacy and protection across dosing regimen

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Real-world Data

See how BeneFIX® performs in real-life settings.

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