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Healthcare Professionals

References

  1. ADYNOVATE® Prescribing Information.
  2. Data on file; Shire US Inc.
  3. Harvard Business School. Lehman Brothers Collection. Baxter Laboratories, Inc. 2012. http://www.library.hbs.edu/hc/lehman/company.html?company=baxter_ laboratories_inc. Accessed December 14, 2016.
  4. Bertolini J, Goss N, Curling J. Production of Plasma Proteins for Therapeutic Use. John Wiley & Sons http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470924314.html. Accessed December 14, 2016.
  5. U.S. Food & Drug Administration. User fee billable biologic product and potencies approved under section 351 of the PHS Act. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122936.htm. Accessed December 14, 2016.
  6. Leveton LB, Sox HC Jr, Stoto MA, eds. Committee to Study HIV Transmission Through Blood and Blood Products, Institute of Medicine. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. National Academies Press;1995. http://www.nap.edu/catalog/4989.html. Accessed February 1, 2017.
  7. Farb et al. Method of purifying factor VIII-C. U.S. Patent 4,758,657. July 19, 1988. http://www.freepatentsonline.com/5470954.html. Accessed December 14, 2016.
  8. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics – from whole-blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35:141-148.
  9. ADVATE® Prescribing Information.
  10. Turecek PL, Bossard MJ, Graninger M, et al. BAX 855, a PEGylated rFVIII product with prolonged half-life. Development, functional and structural characterisation. Hamostaseologie. 2012;32(suppl 1):S29-S38.
  11. Milla P, Dosio F, Cattel L. PEGylation of proteins and liposomes: a powerful and flexible strategy to improve the drug delivery. Curr Drug Metab. 2012;13(1):105-119.
  12. Mullins ES, Stasyshyn O, Alvarez-Román MT, et al. Extended half-life pegylated, full-length recombinant factor VIII for prophylaxis in children with severe haemophilia A. Haemophilia. 2016 Nov 27. doi: 10.1111/hae.13119 [Epub ahead of print].
  13. Half-life definition. MedlinePlus. http://c.merriam-webster.com/medlineplus/halflife. Accessed December 5, 2016.
  14. Median definition. MedlinePlus website. http://c.merriam-webster.com/medlineplus/median. Accessed December 5, 2016.
  15. Interquartile Range definition. MedlinePlus. https://www.merriam-webster.com/dictionary/interquartile%20range. Accessed December 5, 2016.
  16. Konkle BA, Stasyshyn O, Chowdary P, et al. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015;126(9):1078-1085.
  17. Brand B, Gruppo R, Wynn TT, et al. Efficacy and safety of pegylated full-length recombinant factor VIII with extended half-life for perioperative haemostasis in haemophilia A patients. Haemophilia. 2016;22(4):e251-258.
  18. Kramer TAM. Side effects and therapeutic effects. Medscape Gen Med. 2003;5(1). Medscape http://www.medscape.com/viewarticle/448250_print. Accessed February 16, 2016.
  19. Shapiro AD, Korth-Bradley J, Poon MC. Use of pharmacokinetics in the coagulation factor treatment of patients with haemophilia. Haemophilia. 2005;11(6):571-582.
  20. Delivery of treatment for haemophilia: report of a joint WHO/WFH/ISTH meeting. World Health Organization: London, United Kingdom; February 11-13, 2002.
  21. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1): e1-e47.
  22. Webster R, Didier E, Harris P, et al. PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metab Dispos. 2007;35(1):9-16.
  23. Prophylaxis: Barriers and challenges. World Federation of Hemophilia website. http://www.wfh.org/en/abd/prophylaxis/prophylaxis-barriers-and-challenges. Accessed March 18, 2016.
  24. Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20(5):607-615.
Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ADYNOVATE when you have surgery. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE 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 ADYNOVATE 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 ADYNOVATE 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 ADYNOVATE.
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.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

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.

Click here for ADYNOVATE 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.

Click here for ADVATE full Prescribing Information.