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Terms and Conditions

Online Service Terms and Conditions

Through your access to and use of this site, you accept, without limitation or qualification, the terms and conditions set forth below.

  1. Certain information displayed on this site is either the property of, or is used with permission by, Baxter Healthcare Corporation (hereafter Baxter). You should assume that all contents of this site are copyrighted unless otherwise noted and may not be used in a manner inconsistent with the terms and conditions herein without the express written permission of Baxter. You may freely browse this site and download material solely for your own personal, noncommercial use. However, you may not otherwise reproduce, repost, transmit, display, distribute, or modify materials. Images of people, characters, or places displayed on this site are either the property of, or used with permission by, Baxter. The unauthorized use of these images is expressly prohibited.
  2. In no event shall Baxter or any party involved in creating or producing this site be liable for any special, indirect, or consequential damage or any damages whatsoever resulting from loss related to the use of this site, whether in an action of contract, negligence, or other tortious action arising out of, or in connection with, the use of the materials contained on this site. This site and the material contained herein are provided on an “as is” basis by Baxter. Your use of this site is at your own risk. The information is provided to you without any warranties, express, statutory, or implied, including but not limited to any implied warranties of merchantability, noninfringement of third party rights, and fitness for a particular purpose.
  3. The links to other sites provided in this site will let you leave this site. The links are not under the control of Baxter, and Baxter is not responsible for the content of any linked site or any link contained in a linked site. Baxter is providing these links to you only as a convenience, and the inclusion of any link does not indicate or imply any endorsement by Baxter of the site. You are responsible for complying with all terms and conditions governing the use of linked sites.
  4. Trademarks, service marks, and logos displayed on this site are registered and unregistered marks of Baxter International Inc. and others. Nothing contained in this site should be construed as granting you any license or right in or to the marks.
  5. This site could contain technical inaccuracies and/or typographical errors. Baxter may make improvements and/or changes in the materials contained on the site at any time.
  6. This site is operated from servers located in the State of Illinois, USA. The laws of ILLINOIS, exclusive of conflict of law principles, shall govern this agreement.
  7. This site is intended for use only by residents of the United States and Canada. Countries outside of the United States and Canada may have different regulatory requirements or medical practices and may require reference to different or additional information. Therefore, the information presented here may not be appropriate outside of the United States and Canada.

SPECIAL NOTICE TO HEALTH-CARE PROFESSIONALS

By using this site, you acknowledge that Baxter is providing the materials for informational purposes only, and that neither Baxter nor others who have contributed information to this site are providing the materials to you for the purposes of giving you medical advice. You should not rely on the materials in deciding on a treatment plan, drug usage, or any other medical advice.

Before prescribing, please see full prescribing information.

SPECIAL NOTICE TO WEB SITE VISITORS

By using this site you acknowledge that Baxter is providing the material for informational purposes only, and that neither Baxter nor others who have contributed information to this site are providing the materials to you for the purposes of giving you medical advice. You should not rely on the materials in deciding on a treatment plan, drug usage, or any other medical advice. Baxter strongly urges that you consult with a physician in connection with any and all treatment options that may be available to you.

Baxter is a trademark of Baxter International Inc.
Copyright © 2005, Baxter Healthcare Corporation.

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