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 [Antihemophilic Factor (Recombinant), PEGylated] in patients with severe hemophilia A.3
†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
SELECTED IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache and nausea.
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
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