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  1. BeneFIX® Coagulation Factor IX (Recombinant) Prescribing Information, Wyeth Pharmaceuticals Inc.

  2. National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Recommendation #126. November 17, 2001.

  3. Soucie JM, Robertson BH, Bell BP, et al. Hepatitis A virus infections associated with clotting factor concentrate in the United States. Transfusion. 1998;38:573-579.

  4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry: preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by human cells, tissues, and cellular and tissue-based products (HCT/Ps). Draft guidance. June 2002.

  5. Adamson S, Charlebois T, O'Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35:22-27.

  6. 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;98:3600-3606.

  7. Statement by Kathryn C. Zoon, PhD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Department of Health and Human Services, Before the Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Reform and Oversight. U.S. House of Representatives, July 31, 1997. Available at: http://www.fda.gov/ola/plasma.htm. Accessed May 10, 2000.

  8. Ragni MV, Pasi KJ, White GC, et al. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8:91-97.

  9. Poon M-C, Lillicrap D, Hensman C, et al. Recombinant factor IX recovery and inhibitor safety: a Canadian post-licensure surveillance study. Thromb Haemost. 2002;87:431-435.

  10. Courter SG, Beach KJ. Call for post-licensing human pharmacokinetic studies of administration of recombinant factor IX. Haemophilia. 1998;4:136-137.

  11. Harrison S, Adamson S, Bonam D, et al. The manufacturing process for recombinant factor IX. Semin Hematol. 1998;35(suppl 2):4-10.

  12. Lubiniecki AS. Relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products. Dev Biol Stand. 1998;96:173-175.

  13. Bush L, Webb C, Bartlett L, et al. The formulation of recombinant factor IX: stability, robustness, and convenience. Semin Hematol. 1998;35(suppl 2):18-21.

  14. Bond M, Jankowski M, Patel H, et al. Biochemical characterization of recombinant factor IX. Semin Hematol. 1998;35(suppl 2):11-17.

  15. White G, Shapiro A, Ragni M, et al. Clinical evaluation of recombinant factor IX. Semin Hematol. 1998;35(suppl 2):33-38.

  16. ReFacto® Antihemophilic Factor, Recombinant Prescribing Information, Wyeth Pharmaceuticals Inc.

  17. RecombinateTM Antihemophilic Factor (Recombinant) Prescribing Information, Baxter International Inc., Westlake Village, CA.

  18. Advate® Antihemophilic Factor (Recombinant) Prescribing Information, Baxter International Inc., Westlake Village, CA.

  19. Kogenate® FS Antihemophilic Factor (Recombinant) Prescribing Information, Bayer HealthCare LLC, Tarrytown, NY.

  20. Helixate® FS Antihemophilic Factor (Recombinant) Prescribing Information, CSL Behring LLC, Kankakee, IL.

  21. Data on file, Wyeth Pharmaceuticals Inc.

  22. Lusher JM, Lee CA, Kessler CM, Bedrosian CL, for the ReFacto Phase 3 Study Group. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A. Haemophilia. 2003;9:38-49.

  23. Lusher JM, Roth DA. The safety and efficacy of B-domain deleted recombinant factor VIII concentrates in patients with severe haemophilia A: an update [letter]. Haemophilia. 2005;11:292-293.

  24. Berntorp E. Second generation, B-domain deleted recombinant factor VIII. Thromb Haemost. 1997;78:256-260.

  25. Carlsson KS, Höjgård S, Glomstein A, et al. On-demand vs. prophylactic treatment for severe haemophilia in Norway and Sweden: differences in treatment characteristics and outcome. Haemophilia. 2003;9:555-566.

  26. Eriksson RK, Fenge C, Lindner-Olsson E, et al. The manufacturing process for B-domain deleted recombinant factor VIII. Semin Hematol. 2001;38(suppl 4):24-31.

  27. Charlebois TS, O'Connell BD, Adamson SR, et al. Viral safety of B-domain deleted recombinant factor VIII. Semin Hematol. 2001;38(Suppl 4):32-39.

  28. Schwartz RS, Abildgaard CF, Aledort LM, et al, and the Recombinant Factor VIII Study Group. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. N Engl J Med. 1990;323:1800-1805.

  29. Abshire TC, Brackmann HH, Scharrer I, et al, and the International Kogenate-FS Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost. 2000;83:811-816.

  30. White GC II, Courter S, Bray GL, et al, and the Recombinate Previously Treated Patient Study Group. A multicenter study of recombinant factor VIII (RecombinateTM) in previously treated patients with hemophilia A. Thromb Haemost. 1997;77:660-667.

  31. Tarantino MD, Collins PW, Hay CRM, et al, and the rAHF-PFM Clinical Study Group. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia. 2004;10:428-437.

  32. Sandberg H, Almstedt A, Brandt J, et al. Structural and functional characteristics of the B-domain-deleted recombinant factor VIII protein, r-VIII SQ. Thromb Haemost. 2001;85:93-100.

  33. Lind P, Larsson K, Spira J, et al. Novel forms of B-domain-deleted recombinant factor VIII molecules: construction and biochemical characterization. Eur J Biochem. 1995;232:19-27.

  34. Kessler CM, Gill JC, White GC II, et al. B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: a randomized, three-way crossover study. Haemophilia. 2005;11:84-91.

  35. Marquette KA, Pittman DD, Kaufman RJ. The factor V B-domain provides two functions to facilitate thrombin cleavage and release of the light chain. Blood. 1995;86:3026-3034.

  36. Thompson AR. Structure and function of the factor VIII gene and protein. Semin Thromb Hemost. 2003;29:11-22.

  37. ReFacto Laboratory StandardTM Product Information. Genetics Institute, Inc. 2003.

  38. Rodriguez-Merchan EC. Orthopaedic surgery in persons with haemophilia A. Thromb Haemost. 2003;89:34-42.

  39. Manco-Johnson MJ, Blanchette VS. North American prophylaxis studies for persons with severe haemophilia: background, rationale and design. Haemophilia. 2003;9(suppl 1):44-49.

  40. Aledort LM, Haschmeyer RH, Pettersson H, and the Orthopaedic Outcome Study Group. A longitudinal study of orthopaedic outcomes for severe factor-VIII-deficient haemophiliacs. J Intern Med. 1994;236:391-399.

  41. Szucs TD, Öffner A, Schramm W. Socioeconomic impact of haemophilia care: results of a pilot study. Haemophilia. 1996;2:211-217.

  42. Arun B, Kessler CM. Clinical manifestations and therapy of the hemophilias. In: Colman RW, Hirsch J, Marder VJ, et al, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2000:815-824.

  43. Kessler CM, Sachse K. Factor VIII:C inhibitor associated monoclonal-antibody purified FVIII concentrate. Letter. Lancet. 1990;355:1403.

  44. Sandberg H, Almstedt A, Brandt J, et al. Structural and functional characterization of B-domain deleted recombinant factor VIII. Semin Hematol. 2001;38(suppl 4):4-12.

  45. Sante Report, Market Research Findings, April 2004.

  46. Dunn AL, Abshire TC. Recent advances in the management of the child who has hemophilia. Hematol Oncol Clin N Am. 2004;18:1249-1276.

  47. Fiebig EW, Busch MP. Emerging infections in transfusion medicine. Clin Lab Med. 2004:24;797-823.

  48. Baxter receives FDA approval for ultra-high dosage strength of Advate for hemophilia A [press release]. Deerfield, IL: Baxter International, Inc.; May 9, 2006.

  49. Proplex® T Factor IX Complex Prescribing Information. Baxter Healthcare Corporation, Westlake Village, CA.

  50. Mononine® Coagulation Factor IX (Human) Prescribing Information. CSL Behring LLC, Kankakee, IL.

  51. Bebulin® VH Factor IX Complex Prescribing Information. Baxter Healthcare Corporation, Westlake Village, CA.

  52. AlphaNine® SD Coagulation Factor IX (Human) Prescribing Information, Grifols Biologicals Inc., Los Angeles, CA.

  53. Profilnine® SD Factor IX Complex Prescribing Information. Grifols Biologicals Inc., Los Angeles, CA.

  54. Di Paola J, Smith MP, Klamroth R et al. ReFacto® and Advate®: a single-dose, randomized, two-period crossover pharmacokinetics study in subjects with haemophilia A. Haemophilia. 2007; 13:124-130.


The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.


     
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