This site is intended only for healthcare professionals resident in India




Sign InLog Out
Our medicinesTherapy areasExplore ContentExplore contentEventsMaterialsVideosLet's connectLet's ConnectPfizer medical information



AboutAboutHeritageMechanism Of ActionPatient ProfilesStable SHL PatientsPatient on the MovePatients Currently Taking an EHLPatient Actively Involved in SportAboutPurification ProcessDosingRecommended Dosing SchedulesProphylaxisOn-demandAdministrationDose AdministrationEfficacy and SafetyEfficacy and SafetyClinical EfficacySafety ProfileMonitoringPatient Reported OutcomesReal-world dataSupport & ServicesSupport & ServicesPrescribing InformationExplore MaterialsExplore VideosLatest ArticlesExplore Events
DosingRecommended dose modificationsDose Administration


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.

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. AF. Summary of product characteristics. Pfizer. Accessed May 2, 2022. 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. 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. 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. 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



BeneFIX® provides dosing options based on individual needs

Learn more

Efficacy and Safety

Proven efficacy and protection across dosing regimen

Review efficacy profile

Real-world Data

See how BeneFIX® performs in real-life settings.

Review real-world data

PfizerPro AccountPfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign in or RegisterSign inRegisterAccountSign Out
These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.
Address: The Capital,  A Wing, 1802, 18th Floor, Plot No. C-70, ‘G’ Block, Bandra Kurla Complex, Bandra East, Mumbai – 400051, India.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.


Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.


Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst quisque sagittis purus sit amet volutpat. Lectus magna fringilla urna porttitor rhoncus. Venenatis urna cursus eget nunc scelerisque viverra. Id donec ultrices tincidunt arcu non sodales.

Sagittis aliquam malesuada bibendum arcu vitae elementum curabitur. Pellentesque elit ullamcorper dignissim cras tincidunt. Orci ac auctor augue mauris augue neque. Dui vivamus arcu felis bibendum ut tristique et egestas quis. Sed vulputate mi sit amet mauris commodo.

Nunc eget lorem dolor sed viverra ipsum. Sed ullamcorper morbi tincidunt ornare.

Copyright © 2023 Pfizer Limited, India. All rights reserved. Applicable for Pfizer Products, Product Microsites and Therapy Areas section of the website:
  • All content published herein is intended and strictly only for informational, educational, academic and/or research purposes and shall not be utilized to diagnose or treat a health problem or disease without referring to the full prescribing information for list of approved indications as contained in the product package insert
  • While due care and caution has been taken to ensure that the content herein is free from mistakes or omissions, Pfizer makes no claims, promises or guarantees about the accuracy, completeness or adequacy of the information herein
For the use only of Registered medical practitioners* or a Hospital or a Laboratory

These pages are not intended for patients or for members of the general public. The web pages contain promotional content.


If you select 'No', you will be redirected to

For more details on, Who is a Registered medical practitioner*, please visit "", Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.

PP-DOL-IND-0251 18 JAN 2023
Yes No
You are now leaving PfizerPro website

​​​​​You are now leaving Pfizer Pro website and will be redirected to another website. Note that you will be governed by the Terms & Conditions and Privacy Policy of the external website. Would you like to continue?
PP-DOL-IND-0251 18 JAN 2023