Unlocking Self-Potential

References

  1. Shire Press Release March 5, 2018, "Shire launches myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] in the U.S."
  2. myPKFiT for Patients manual v2.1
  3. ADVATE Prescribing Information.
  4. Shapiro AD, Schoenig-Diesing C, Silvati-Fidell L, Wong WY, Romanov V. Integrated analysis of safety data from 12 clinical interventional studies of plasma and albumin-free recombinant factor VIII (rAHF-PFM) in haemophilia A. Haemophilia. 2015;21(6):791-798.
  5. 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 [published correction appears in J Thromb Haemost. 2012;10(6):1204]. J Thromb Haemost. 2012;10(3):359-367.
  6. Auerswald G, Thompson AA, Recht M, et al. Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012;107(6):1072-1082.
  7. National Hemophilia Foundation. MASAC recommendation #243 on SIPPET (Survey of Inhibitors in Plasma-Product-Exposed Toddlers): results and recommendations for treatment products for previously untreated patients with hemophilia A. https://www.hemophilia.org/sites/default/files/document/files/243SIPPET.pdf. Published June 2016. Accessed March 22, 2017.
  8. Interquartile Range definition. Merriam-Webster website. https://www.merriam-webster.com/dictionary/interquartile. Accessed February 27, 2017.
  9. 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;105:428-437.
  10. 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(2):186-201.
  11. 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(2):217-223.
  12. 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(8):1319-1326.
  13. Data on file; Takeda US Inc.
  14. 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. https://www.ncbi.nlm.nih.gov/pubmed/?term=an+adventure+in+biotechnology%3A+the+development+of+haemophilia+A+therapeutics
  15. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders. MASAC Document #210. May 2012.
  16. McCormack PL, Plosker GL. Octocog alfa, plasma/albumin-free method. Drugs. 2005;65(18):2613-2620.
  17. Maruish ME, ed. User’s Manual for the SF-36v2 Health Survey. 3rd ed. Lincoln, RI: QualityMetric Incorporated; 2011.
  18. myPKFiT for Health Professionals User Manual v3.0. Shire, Inc.
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ADVATE [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in

SELECTED IMPORTANT RISK INFORMATION

Who should not use ADVATE?

Do not use ADVATE if you:

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

  • 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 (HCP) 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

Who should not use ADVATE?

Do not use ADVATE if you:

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

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

What should I tell my HCP before using ADVATE?

Tell your HCP 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.
  • Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

  • You can have an allergic reaction to ADVATE. Call your HCP 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.
  • Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE and Hemophilia A?

  • 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. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADVATE?

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

For additional safety information, click here for Prescribing Information and discuss with your HCP.

myPKFiT for ADVATE Patients Mobile Application Intended Use

  • The myPKFiT for Patients Mobile Application (“myPKFiT Mobile App”) is intended for use by patients with hemophilia A being treated with ADVATE [Antihemophilic Factor (Recombinant)] who are 16 years of age or older with a body weight of 45 kg or higher, and their caregivers.
  • The myPKFiT Mobile App is designed to make it convenient for you to record your infusion and bleed events, track your estimated Factor VIII levels following a prophylactic infusion, and export the data for review by your healthcare provider (“HCP”).
  • Your HCP can use the myPKFiT software to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis using your age, body weight information, and laboratory tests that measure your Factor VIII clotting activity. Using myPKFiT software, HCPs can evaluate various prophylaxis dose regimens tailored to your individual needs and treatment plan.
  • myPKFiT Mobile App should only be used by hemophilia A patients treated with ADVATE, as per the ADVATE Prescribing Information.
  • myPKFiT Mobile App is not indicated for use by patients with von Willebrand disease. myPKFiT Mobile App should not be used by patients who have developed inhibitors to Factor VIII products.

myPKFiT for Patients Mobile Application is Rx only. For safe and proper use of the myPKFiT Mobile App, please refer to the complete instructions for use in the User Manual.