Indications and Limitation of Use: ADYNOVATE® [Antihemophilic factor (Recombinant), PEGylated] is a human antihemophilic factor indicated for use in children and adults with hemophilia A for the control and prevention of bleeding episodes. ADYNOVATE is not indicated for the treatment of von Willebrand disease.1
Overall hemostatic efficacy was rated as excellent in all evaluable surgical procedures studied with ADYNOVATE†‡§1,2
study design
In a phase 3, multicenter, prospective, open-label, uncontrolled surgery study, 21 major surgical procedures and 5 minor surgeries were performed in 21 patients. The primary endpoint was the evaluation of perioperative hemostatic efficacy of ADYNOVATE in patients with severe hemophilia A.1,2
SELECTED IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVATE. Hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus, and nausea and vomiting. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
See Detailed Important Risk Information below.
study results1
| Types of Major surgeries (N=21) | |
|---|---|
| Orthopedic | Achilles Tendon Reconstruction |
| Alloplastic Knee Surgery | |
| Arthroscopic Synovectomy | |
| Elbow Cyst Extirpation | |
| Hip Replacement | |
| Hip Replacement Revision | |
| Knee Replacement | |
| Needle Removed From Elbow | |
| Non-Orthopedic | CVAD Placement |
| Gastric Band Insertion | |
| Multiple Tooth Extractions | |
| Types of Minor surgeries (N=5) | |
| Dental Procedure | |
| Dermatological | |
| Radiosynovectomy | |
| Synoviorthesis | |
†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).
‡Excellent defined as blood loss less than or equal to that expected for the same type of procedure performed in a nonhemophilic patient, and required blood components for transfusions less than or similar to those expected in nonhemophilic population.
§Ratings were conducted for 24 evaluable procedures (21 major, 3 minor)
SELECTED IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVATE. Hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus, and nausea and vomiting. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
See Detailed Important Risk Information below.
IMPORTANT RISK INFORMATION
