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Established Safety Profile
Previously Treated Patients (PTPs)

The safety of ADVATE® [Antihemophilic Factor (Recombinant)] was evaluated from 8 studies in 276 PTPs with moderately severe to severe hemophilia A. PTPs were defined as having ≥50 or ≥150 exposure days (EDs) to factor VIII products, depending on the study. In this analysis, PTPs were defined as patients with ≥50 EDs. For PTP inhibitor incidence, all PTPs with ≥10 consecutive EDs (N=276) during the course of individual studies were included in the analysis. EDs were defined as calendar days on which rAHF-PFM (recombinant Antihemophilic Factor – Manufacture Protein Free) was administered.2

Low risk of inhibitor development in PTPs demonstrated in clinical studies2

  • 1 PTP developed a non-persistent, low titer inhibitor.*2

*There was 1 additional 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.3

CI=confidence interval.

SELECTED IMPORTANT RISK INFORMATION

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.

Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs)

The safety of ADVATE [Antihemophilic Factor (Recombinant)] was evaluated in a multicenter, open-label clinical study of 55 previously untreated patients (PUPs) and minimally treated patients (MTPs) <6 years of age with severe (FVIII level <1%) or moderately severe (FVIII level 1%–2%) hemophilia A determined at baseline. PUPs and MTPs were defined as having had up to 3 exposures to a factor VIII product at time of enrollment. Patients were followed for 75 exposure days or 3 years, whichever occurred first. The primary safety endpoint was the percentage of subjects who developed an inhibitor to factor FVIII.1,4

In a study investigating immunogenicity, results showed a:

  • Talk to your doctor about the differences in expected inhibitor rates between PUPs, MTPs and PTPs
  • Inhibitors were detected at a median of 13 exposure days (EDs); min-max: 6-26 EDs
  • 7 subjects developed high-titer (>5 BU) inhibitors, and 9 subjects developed low-titer inhibitors

“The development of inhibitors (neutralizing antibodies to factor VIII) is the most significant current treatment-associated complication of hemophilia A, affecting up to 30% of previously untreated patients (PUPs) treated with factor VIII (FVIII)."5
∼ per MASAC

†MASAC=Medical and Scientific Advisory Council, National Hemophilia Foundation.

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.