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Safety Profile4,7-12

Results of published clinical studies for ADVATE [Antihemophilic Factor (Recombinant)].4,7-12

A low risk of inhibitor development in previously treated patients (PTPs)4,7-10*

  • 1 low titer, nonpersistent inhibitor (<1%) in the pivotal study8,a,b (n=108)
  • 0 inhibitors in a continuation study7,a,b (n=82)
  • 0 inhibitors in a pediatric study10,c (n=53)
  • 0 inhibitors in a surgery study9,a,b (n=59)
  • 0 inhibitors in a Japanese study7 (n=15)
  • 0 inhibitors in a prophylaxis study4,a,d (n=73)

Low PTP inhibitor rate4,7-10
(0.37%, 95% confidence interval, 0.02%-2.13%)

Less than 1/2 of 1% incidence

*PTPs are considered to be the most appropriate study population for the assessment of product-related immunogenicity.15 Six clinical studies of PTPs with moderately severe to severe hemophilia A demonstrated a low inhibitor rate of 0.37%.4,7-10

aPatients with an estimated ≥150 factor VIII exposure days.

bSome patients participated in more than 1 study.

cPatients with an estimated ≥50 factor VIII exposure days.

dThere was 1 case of a possible low-titer factor VIII inhibitor, which was unconfirmed, unaccompanied by symptoms of inhibitor presence, and disappeared at the subject’s subsequent test.

Indications and Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)].
See full Prescribing Information.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information


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.


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.