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.

Bleed control in major surgical
procedures1

As reported in interim study results, the median observed intraoperative blood loss was lower than the predicted average blood loss for major surgeries.1

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

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.

study results

Image graph - 10mL is median observed  blood loss. 50 is mL median predicted average blood loss. Image graph - 10mL is median observed  blood loss. 50 is mL median predicted average blood loss.

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 preoperative loading dose ranged from 36 IU/kg to 99 IU/kg (median: 65 IU/kg), and the total postoperative dose ranged from 177 IU/kg to 769 IU/kg (median: 305 IU/kg)1
  • The median total dose for major surgeries was 362 IU/kg (237 IU/kg to 863 IU/kg), and the median total dose for minor surgeries was 97 IU/kg (73 IU/kg to 119 IU/kg)1
  • The intraoperative blood loss could not be assessed for 1 major dental surgery

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.

Surgery study dosing
information

Major surgeries1 Minor surgeries1
Median
total
dose
362 IU/KG(237 IU/kg-
863 IU/kg)
97 IU/KG(73 IU/kg-
119 IU/kg)
Dose range
Pre
operative
loading
dose
36 IU/KG-
99 IU/KG(median: 65 IU/kg)
Total
post-
operative
dose
177 IU/KG-
769 IU/KG(median: 305 IU/kg)
Safety profile

ADYNOVATE has an established and consistent safety profile across 7 clinical studies

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Personalize patient treatment

ADYNOVATE has a twice-weekly dosing regimen that you can tailor to each patient

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