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References

  1. ADYNOVATE® Prescribing Information.
  2. 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].
  3. Data on File; Shire US Inc.
  4. Interquartile Range definition. MedlinePlus. https://www.merriam-webster.com/dictionary/interquartile%20range. Accessed December 5, 2016.
  5. 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.
  6. Turecek PL, Bossard MJ, Graninger M, et al. BAX 855, a PEGylated rFVIII product with prolonged half-life: development, functional and structural characterisation. Hämostaseologie. 2012;32(Suppl 1): S29-S38.
  7. 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.
  8. 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-e258.
  9. ADVATE® Prescribing Information.
  10. 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.
  11. 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.
  12. 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
  13. 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.
  14. 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.
  15. 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.
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Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Click here for ADYNOVATE Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • Control and prevention of bleeding episodes.
  • Perioperative management.
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Neutralizing Antibodies
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

  • Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
  • The most common adverse reactions observed in clinical trials (>% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

Click here for ADVATE Prescribing Information.