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
‡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
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
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.
ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in
Do not use ADVATE if you:
ADVATE is not used to treat von Willebrand disease.
Do not use ADVATE if you:
Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.
Tell your HCP if you:
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 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.