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References

  1. ADVATE Prescribing Information. Westlake Village, CA: Baxalta Healthcare Corporation; May 2015.
  2. PROLabels: patient-reported outcomes & drug marketing authorizations. ProLabels Web site. http://www.mapi-prolabels.org. Accessed December 2014.
  3. Maruish ME, ed. User’s Manual for the SF-36v2 Health Survey. 3rd ed. Lincoln, RI: QualityMetric Incorporated; 2011.
  4. Valentino LA, Mamonov V, Hellmann A, et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. J Thromb Haemost. 2012;10(3):359-367.
  5. Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4:186-201.
  6. Data on file. Westlake Village, CA; Baxalta Healthcare Corporation.
  7. 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;9:273-283.
  8. 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.
  9. Negrier 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.
  10. 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.
  11. Oldenburg J, Goudemand J, Valentino L, et al. Post authorization safety surveillance of ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice. Haemophilia. 2010;16(6):866-877.
  12. Auerswald G, Thompson A, Recht M, et al. Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012;107:1072-1082.
  13. Pipe SW. Functional roles of the factor VIII B domain. Haemophilia. 2009;15:1187-1196.
  14. Jankowski MA, Patel H, Rouse JC, Marzilli LA, Weston SB, Sharpe PJ. Defining ‘full-length’ recombinant factor VIII: a comparative structural analysis. Haemophilia. 2007;13:30-37.
  15. 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 on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 1999;81:462.
  16. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of hemophilia A therapeutics: from whole blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35:141-148.
  17. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders. MASAC Document #210. May 2012.
  18. World Federation of Hemophilia. Hemophilia—a timeline. http://www1.wfh.org/2/1/1_1_3_Link1_Timeline.htm. Accessed October 15, 2012.
  19. RECOMBINATE [Antihemophilic Factor (Recombinant)] prescribing information. Westlake Village, CA: Baxalta Healthcare Corporation; December 2010.
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Indications and Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)].
See full Prescribing Information.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADVATE if you:

  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.

Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.

You should tell your healthcare provider if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

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 ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

You can have an allergic reaction to ADVATE.

Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.

Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see ADVATE full Prescribing Information.