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Established Safety Profile

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

The safety of ADYNOVATE® 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

Zero inhibitors to ADYNOVATE were reported in PTPs
  • 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

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Indications and Limitation of Use

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

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

Indications and Limitation of Use

ADYNOVATE 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

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

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications and Limitation of Use

ADYNOVATE 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

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

DETAILED IMPORTANT RISK INFORMATION

Click here for ADYNOVATE Prescribing Information.



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.

  • Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
  • The most common adverse reactions observed in clinical trials (>% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

Click here for ADVATE Prescribing Information.