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ADVATE Real-World Experience

Only ADVATE [Antihemophilic Factor (Recombinant)] has over 11 years of experience in the real world as a latest generation plasma/albumin-free recombinant factor VIII.5

  • More than 20 billion IUs distributed worldwide6
  • Proven record of clinical performance and safety profile4,7-10
  • Extensively studied recombinant factor VIII treatment4,7-12
  • Third-generation full-length molecule that uses the complete gene, similar to the factor VIII that occurs naturally in the body1,5

Commitment to Hemophilia A Treatment Innovation

Shire is committed to improving the everyday lives of people with hemophilia by advancing treatment and support programs and services.

1992
First Generation

First recombinant factor VIII.16
Recombinant, with plasma-derived proteins in culture medium and final formulation.

By 1992, RECOMBINATE [Antihemophilic Factor (Recombinant)] became available, but blood components, such as plasma proteins, are still added at several steps of the processing.16-19

Late 1990s
Second Generation

Recombinant, with plasma-derived proteins in culture medium, but not in final formulation.

The amount of blood components used in processing was reduced, although some still remain.

Specifically, plasma proteins are still used in the cell-growth phase.17

2002

First needleless transfer device: BAXJECT.6

2003
Third Generation:
ADVATE

First recombinant factor VIII free of blood-based additives, introducing the latest generation of treatment: ADVATE.5

Recombinant, with no plasma-derived proteins in culture medium or final formulation.

In 2003, ADVATE was introduced as the first recombinant factor VIII treatment to be free of blood-based additives. No plasma proteins are added at any stage of processing.1,17,20

There have been no confirmed reports of viral transmission with recombinant factor VIII treatments.

2006

First needleless transfer device designed specifically to improve patient convenience: BAXJECT II device.6

2007

First factor VIII 3000 IU single-vial dose.6

2010

First & only recombinant factor VIII 1700 IU single-vial dose.6

2011

First & only recombinant factor VIII with physical health-related quality of life results.1,2,a

2012

First & only factor VIII 4000 IU single-vial dose.1

2012

First & only factor VIII 2 mL diluent option (250, 375, 500, 750, 1000, 1500, and 1700 IU).1

aBased on a list of other drugs and biologics approved with health-related quality of life data in the labeling, as of November 2014.2

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.