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ADVATE® Has an Established Safety Profile in 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 FVIII 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 was administered.3

Low risk of inhibitor development in PTPs demonstrated in clinical studies3

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Incidence of inhibitors
ADVATE [Antihemophilic Factor (Recombinant)] in 6 clinical studies, 270 patients had a .37% incidence of inhibitors. (95% confidence interval, 0.02% - 2.13%)
  • One PTP developed a non-persistent, low titer inhibitor.*3

*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.2

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS
Neutralizing Antibodies

Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

ADVATE has an established safety profile in PUPs and 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 FVIII.1,7

In a study investigating immunogenicity in PUPs, results showed a1,7

  • 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).”11
– Per MASAC