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Confidence

ADVATE Has A Low Risk of Inhibitor Development in Clinical Studies

Guidelines suggest that the risk for inhibitors related to an individual product should be evaluated in PTPs.18

  • ADVATE therapy has demonstrated a low rate of inhibitor development in PTPs in clinical studies.4,6,a-d
  • Of 198 PTPs in clinical trials, 1 person developed a low-titer inhibitor that was no longer detectable 8 weeks later.4,6,a-d
  • The formation of inhibitors has been observed with all factor VIII products, including ADVATE.

Inhibitor Rates From Clinical Studies in PTPs4,6,7

Clinical Study (N) Detected Inhibitors (%)
Pivotal studyb (N=108) 1 (<1%)—low titer, non-persistent
Continuation studyb,c (N=82) 0 (0%)
Pediatric studyd (N=53) 0 (0%)
Surgery studyb,c (N=58) 0 (0%)
Japanese study (N=15) 0 (0%)
ADVATE Therapy's demonstrated safety

a The rate [95% confidence interval] for developing an inhibitor in PTPs (factor VIII ≤2%) was 0.51% [0.03%-2.91%] based on completed study analysis.6

b Patients with an estimated ≥150 factor VIII exposure days.

c Some patients participated in more than 1 study.

d Patients with an estimated ≥50 factor VIII exposure days.

“ADVATE helps me every day. With no need to worry about blood-based additives, I can focus more on my life and things that are important to me.” -David. Mt. Washington, KY

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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