Indications and Limitations 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
In interim study results, hemostatic efficacy was rated as excellent in all surgical procedures studied with ADYNOVATE†‡1,2
study design
In a phase 3, multicenter, prospective, open-label, uncontrolled surgery study, 11 major surgical procedures and 4 minor surgeries were performed in 15 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 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.
See Detailed Important Risk Information below.
study results1
Number of procedures (n=15) | Surgery Type |
hemostatic response rating | |
---|---|---|---|
Excellent | Good | ||
Major surgeries1 | |||
3 | knee replacements | ||
2 | arthroscopic synovectomies | ||
1 | cyst extirpation | ||
1 | port replacement | ||
1 | gastric-band replacement | ||
3 | multiple tooth extractions,including 1 radicular cyst removal | ||
Minor surgeries1 | |||
1 | synoviorthesis | ||
1 | radiosynovectomy | ||
1 | tooth extraction | ||
1 | dermatological surgery |
†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.
SELECTED IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions: 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.
See Detailed Important Risk Information below.