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Established Safety Profile

Proven prophylaxis +
simple, twice-weekly dosing schedule =
moments their way

The safety of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] was evaluated in children and adults with severe hemophilia A who received at least 1 dose of ADYNOVATE in 3 completed, multicenter, prospective, open-label clinical studies and 4 ongoing clinical studies.1

  • In the adult and children over 12 study, 8 previously treated patients (negative at screening) developed transient lgG antibodies against FVIII (n=5) or PEG-FVIII (n=3) at 1 or 2 consecutive study visits.1
  • In the study of children under 12, 5 pediatric previously treated patients developed IgG antibodies against PEG-FVIII: transiently (n=2), binding antibodies at the completion of the study (n=2), and developed binding antibodies during the study and positive at completion with decreasing titer (n=1). For all 3 subjects who developed binding antibodies, no conclusion can be drawn whether these antibodies are of transient or persistent nature.1,3
  • One pediatric previously untreated patient from an ongoing study, who received at least one infusion of ADYNOVATE, developed neutralizing antibodies to FVIII.1

*Inhibitors defined as ≥0.6 BU using the Nijmegen modification of the Bethesda assay.3
†Pediatric previously treated patients defined as: <6 years of age with ≥50 EDs, ≥6 to <12 years of age with ≥150 EDs.1

Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION


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ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • Control and prevention of bleeding episodes.
  • Perioperative management.
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

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.

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