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Proven Clinical Experience

Only ADVATE® [Antihemophilic Factor (Recombinant)] has 13 years of experience in the real world as a third-generation plasma/albumin-free recombinant factor VIII.8

  • Extensively studied with evidence spanning over a decade from 12 prospective studies2-4,7,9,10
  • Most widely used* with more than 25 billion International Units (IUs) distributed worldwide11
  • Proven record of clinical performance2-4,7,9,10
  • Third-generation full-length molecule similar to the factor VIII that occurs naturally in the body1,8

* Based on units sold as of July 2016.

Committed to advancing hemophilia A treatments

1992
First Generation

1st genetically manufactured factor VIII.12
Ushers in the era of recombinant factor VIII treatment.

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.8,13

2002

First needleless transfer device: BAXJECT®.11

2003
Third Generation:
ADVATE

First recombinant factor VIII free of blood-based additives, introducing the latest generation of treatment: ADVATE.8

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.1,13,14

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

2006

The redesigned BAXJECT II device allowed mixing in less than 1 minute and included built-in filters to maintain product purity.11

2007

First factor VIII 3000 IU single-vial dose.11

2010

First & only recombinant factor VIII 1700 IU single-vial dose.11

2011

First & only recombinant factor VIII with physical health-related quality of life results in the prescribing information.1

2012

First 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).1,11

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.

Click here for ADVATE full Prescribing Information.