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References

 
  1. Bolton-Maggs PHB, Pasi KJ. Haemophilias A and B. Lancet. 2003;361:1801-1809.

  2. National Center on Birth Defects and Developmental Disabilities. Hereditary Blood Disorders: Hereditary Bleeding Disorders. Atlanta, GA: Centers for Disease Control and Prevention. National Institutes of Health, US Department of Health and Human Services. Available at: http://www.cdc.gov/ncbddd/hbd/hemophilia.htm. Accessed April 17, 2006.

  3. National Heart, Lung, and Blood Institute. What Is Hemophilia? Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_what.html. Accessed April 17, 2006.

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

  5. National Heart, Lung, and Blood Institute. Other Names for Hemophilia. Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_onames.html. Accessed April 17, 2006.

  6. National Heart, Lung, and Blood Institute. What Are the Signs and Symptoms of Hemophilia? Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_signs.html. Accessed April 17, 2006.

  7. National Heart, Lung, and Blood Institute. How Is Hemophilia Diagnosed? Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_diagnosis.html. Accessed April 17, 2006.

  8. National Heart, Lung, and Blood Institute. How Is Hemophilia Treated? Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_treatments.html. Accessed April 17, 2006.

  9. 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 April 23, 2006.

  10. Food and Drug Administration. New Recombinant Antihemophilic Factor Licensed. Rockville, Md: National Press Office; July 23, 2003. Talk Paper T03-55. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01241.html. Accessed April 17, 2006.

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

  12. 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.

  13. National Heart, Lung, and Blood Institute. Living With Hemophilia. Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_living.html. Accessed April 17, 2006.

  14. World Federation of Hemophilia. Frequently asked questions about hemophilia. Available at: http://www.wfh.org/2/1/1_1_1_FAQ.htm. Accessed April 24, 2006.

  15. The American Heritage Stedman's Medical Dictionary. Boston, Mass: Houghton Mifflin Company; 1995.

  16. Resnik S. Appendix A: glossary of terms and acronyms. In: Blood Saga: Hemophilia, AIDS, and the Survival of a Community. Berkeley and Los Angeles: University of California Press; 1999:199-220.

  17. Greaves M, Preston FE. Hemorrhagic disorders: basic concepts. In: Coleman RW, Hirsh J, Marder VJ, et al, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:783-793.

  18. National Heart, Lung, and Blood Institute. What Causes Hemophilia? Bethesda, Md: National Institutes of Health, US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_causes.html. Accessed April 17, 2006.

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

  20. Baxter Factor Assist Program. Hemophilia Galaxy Web site. Available at: http://www.hemophiliagalaxy.com/therapies/hcp/reimbursement/factor_assist.html. Accessed April 28, 2006.

  21. Bayer Kogenate® FS Factor Solutions Program. Bayer Kogenate® FS Factor Solutions Program Web site. Available at: http://www.kogenatefs.com/patients_B-KGFS.cfm. Accessed February 15, 2007.

  22. CSL Behring Assurance Program. CSL Behring Assurance Web site. Available at: http://www.cslbehringassurance.com/AboutAssuranceProgram.aspx?menuitem=2. Accessed February 15, 2007.

  23. 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.

  24. Royal S, Schramm W, Berntorp E, et al, for the European Haemophilia Economic Study Group. Quality-of-life differences between prophylactic and on-demand factor replacement therapy in European haemophilia patients. Haemophilia. 2002;8:44-50.

  25. 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.

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

  27. Lusher JM. Acute hemarthroses: the benefits of early versus late treatment with recombinant activated factor VII. Blood Coagul Fibrinolysis. 2000;11(suppl 1):S45-S49.

  28. Playing It Safe. Bleeding Disorders, Sports and Exercise. National Hemophilia Foundation 2005.

  29. Arun B, Kessler CM. Clinical manifestations and therapy of the hemophilias. In: Colman RW, Hirsh J, Marder VJ, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:815-824.

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

  31. Adamson S, Charlebois T, O'Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35(suppl 2):22-27.

  32. Ragni MV, Pasi KJ, White GC, et al, and the Recombinant FIX Surgical Study Group. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8:91-97.

  33. BeneFIX® Prescribing Information. Wyeth Pharmaceuticals Inc.

  34. 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.

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

  36. ReFacto® Prescribing Information. Wyeth Pharmaceuticals Inc.

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

  38. Advate® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method Prescribing Information. Baxter International Inc., Westlake Village, CA.

  39. Kogenate® FS Antihemophilic Factor (Recombinant) with BIO-SET® Prescribing Information. Bayer HealthCare LLC, Tarrytown, NY.

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

  41. Data on file, Wyeth Pharmaceuticals Inc.

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

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

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

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

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

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

  48. Lynch TJ, Weinstein MJ, Tankersley DL, et al. Considerations of pool size in the manufacture of plasma derivatives. Transfusion. 1996;36:770-775.

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

  50. 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.


  51. 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.

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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