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Evolution of Factor VIII therapy2

Since the introduction of ADVATE, MASAC has described recombinant factor VIII therapy in terms of three generations. Each is defined by the presence or absence of animal and/or human plasma-derived proteins at stages in the processing.2

Blood-based Factor VIII
First Generation
Second Generation
Third Generation: ADVATE

Roll-over each generation to learn more

Nonrecombinant, derived from human blood

In the 1980s, all clotting factor came directly from human blood.

By the mid-1980s, safeguards were developed to monitor and reduce pathogen transmission risk from blood-based additives.8

Recombinant, with plasma-derived proteins in culture medium and final formulation

By 1992, RECOMBINATE [Antihemophilic Factor (Recombinant)] became available, but blood components, such as plasma proteins, are still added at several steps of the processing.2,8,9

Recombinant, with plasma-derived proteins in culture medium, but not in final formulation

A few years later, the amount of blood components used in processing was reduced, although some still remain.

Specifically, plasma proteins are still used in the cell-growth phase, and trace amounts may remain in the final formulation.2

Recombinant, with no plasma-derived proteins in culture medium or final formulation

In 2003, ADVATE was introduced as the first recombinant factor VIII therapy to be free of blood-based additives. No plasma proteins are added at any stage of processing.2,3,4

Please read the Important Risk Information below

Eliminates potential risk of viral transmission2

“When I found out Alan had hemophilia, I learned all I could. It was so helpful to read stories of mothers like me, and know I wasn't the only one going through this situation” -Yudith. Menifee, CA

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ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is a medicine used to replace clotting factor VIII that is missing in people with hemophilia A. ADVATE is used to prevent and control bleeding in people with hemophilia A. Your doctor may give you ADVATE when you have surgery.

ADVATE is not used to treat von Willebrand's Disease.

>Important Risk Information for ADVATE therapy

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

You should tell your doctor if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines and dietary supplements, have any allergies, including allergies to mice or hamsters, are nursing, are pregnant, or have been told that you have inhibitors to factor VIII.

You could have an allergic reaction to ADVATE. Call your doctor right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, light-headed, dizziness, nausea, or fainting.

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop all factor VIII products including ADVATE from working properly. Consult with your doctor to make sure you are carefully monitored with blood tests to check for the development of inhibitors to factor VIII.

Side effects that have been reported with ADVATE include: cough, sore throat, unusual taste, abdominal pain, diarrhea, nausea, headache, fever, dizziness, hot flashes, chills, sweating, joint swelling, itching, hematoma, and swelling of legs.

Call your doctor right away about any side effects that bother you or if your bleeding does not stop after taking ADVATE.

Please see ADVATE full Prescribing Information (PDF).

After using ADVATE therapy, dispose of the empty vial, reconstitution device, and syringe in a sharps container.

References: 1. Industry, financial, and research reports on file. Westlake Village, CA: Baxter Healthcare Corporation. 2. The National Hemophilia Foundation. MASAC Recommendations Concerning the Treatment of Hemophilia and Other Bleeding Disorders. MASAC Document #190. June 2009. 3. McCormack PL, Plosker GL. Octocog alpha, plasma/albumin-free method. Drugs. 2005;65:2613-2620. 4. ADVATE prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; October 2009. 5. 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. 6. Shapiro A, Gruppo R, Pabinger I, et al. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009;9(3):273-283. 7. Data on File. Westlake Village, CA: Baxter Healthcare Corporation. 8. World Federation of Hemophilia. Hemophilia—a timeline. Available at: http://www.wfh.org/2/1/1_1_3_Link1_Timeline.htm. Accessed June 7, 2007. 9. RECOMBINATE prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; January 2010. 10. Ewenstein BM, Collins P, Tarantino MD, et al. Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin-free method. Semin Hematol. 2004;41(2)(suppl 2):1-18. 11. Blanchette VS, Shapiro AD, Liesner RJ, et al, for the rAHF-PFM Clinical Study Group. Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients. J Thromb Haemost. 2008;6:1319-1326. 12. Négrier C, Shapiro A, Berntorp E, et al. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin free method: efficacy and safety of Advate in previously treated patients. Thromb Haemost. 2008;100:217-223. 13. Ewenstein BM, Gomperts ED, Pearson S, O’Banian ME. Inhibitor development in patients receiving recombinant factor VIII (Recombinate rAHF/Bioclate®): a prospective pharmacovigilance study. Haemophilia. 2004;10:491-498. 14. Xyntha prescribing information. Philadelphia, PA: Wyeth Pharmaceuticals Inc; April 2008. 15. Helixate FS prescribing information. Kankakee, IL: CSL Behring LLC; July 2007. 16. Kogenate FS prescribing information. Tarrytown, NY: Bayer Healthcare LLC; October 2008. 17. ReFacto prescribing information. Philadelphia, PA: Wyeth Pharmaceuticals Inc; December 2007. 18. White, GC, DiMichele D, Mertens K, et al. Utilization of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new factor VIII and factor IX concentrates. Recommendation of the Scientific Subcommittee of Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 1998;81:462