Unlocking Self-Potential

Established Safety Profile
Previously Treated Patients (PTPs)

The safety of ADVATE® 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.4

INCIDENCE OF INHIBITORS IN PTPs3,6,7

 0.36% incidence of inhibitors in 8 clinical studies of 276 PTPs with moderately severe to severe hemophilia A (At a range of 95%, Confidence Interval is 0.009% to 2.002%).

Low risk of inhibitor development in PTPs demonstrated in 8 clinical studies; 0.36% incidence of inhibitors in 276 PTPs (95% CI: 0.009%-2.002%).6 One PTP developed a nonpersistent, low-titer inhibitor: there was 1 additional case of a possible low-titer factor VIII inhibitor, which was unconfirmed, was unaccompanied by symptoms of inhibitor presence, and disappeared at the subject’s subsequent test.5



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.



INCIDENCE OF INHIBITORS IN PUPs AND MTPs

29.1% incidence of inhibitors in PUPs and MTPs (16/55), (At a range of 95%, Confidence Interval is 17.1% to 41.1%).

The safety of ADVATE 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.3,7

§In a study investigating immunogenicity, results showed a 29.1% incidence of inhibitors in PUPs and MTPs (16/55).3,7

“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)."7
∼ per MASAC

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

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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.