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Perioperative Interim Data

Hemostatic efficacy was rated as excellent in surgical procedures studied with ADYNOVATE® (as reported in interim study results)†‡1

In the phase III, multicenter, prospective, open-label, uncontrolled interim surgery study results, 11 major surgical procedures and 4 minor surgeries were performed in 15 subjects.1,3

The primary endpoint was the evaluation of perioperative hemostatic efficacy of ADYNOVATE in patients with severe hemophilia A.3

Hemostatic efficacy was rated as excellent in surgical procedures studied with ADYNOVATE

†Using a 4-point rating scale (excellent, good, fair, none), intraoperative and postoperative hemostatic efficacy assessed by the surgeon; overall perioperative hemostatic efficacy evaluated by the investigator at discharge or on postoperative Day 14 (whichever occurred first).8

‡Excellent defined as blood loss less than or equal to that expected for the same type of procedure performed in a non-hemophilic patient, and required blood components for transfusions less than or similar to those expected in non-hemophilic population.1

Bleed control in major surgical procedures (as reported in interim study results)

Interim data from the surgery study showed that the median observed intraoperative blood loss was lower than the predicted average blood loss for major surgeries.§1

Bleed control in major surgical procedures

Median observed intraoperative blood loss was 10.0 mL (IQR: 45.0) vs. predicted average blood loss of 50.0 mL (IQR: 144.0).1

§The intraoperative blood loss could not be assessed for 1 major dental surgery.3

Surgery study dosing Information1

Surgery study dosing Information Surgery study dosing Information
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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.