Normalization of both VWF and FVIII to ensure normal hemostasis1
Avoidance of FVIII accumulation with repeated dosing of VWF/FVIII, which may increase risk of thrombosis5
Close monitoring of VWF and FVIII levels to avoid under- or over-dosing6
Requirements for managing surgery
In people with von Willebrand disease
Prophylaxis with VWF complex*
VWF and FVIII in wilate®
Show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing6*
Parallel decay of VWF:RCo and FVIII:C
May simplify dosing and monitoring
*wilate® is indicated in children and adults with von Willebrand disease for perioperative management of bleeding.
97% of major and minor surgeries
Were managed successfully with wilate®, with no reports of FVIII accumulation in this study3
WONDERS: Prospective, open-label, uncontrolled Phase III study of wilate® in surgery
30 surgeries in 28 patients
(≥12 years of age)
Type 3
21
70%
Type 2
2
7%
Type 1
7
23%
FVIII: factor VIII
30 surgeries in 28 patients
(≥12 years of age)
Major Surgeries
21
70%
Minor Surgeries
9
30%
97% of major and minor surgeries
Were managed successfully with wilate®, with no reports of FVIII accumulation in this study3
Overall efficacy rated as successful* in 97% of surgeries
Success in major surgeries (20/21)
Success in minor surgeries (9/9)
Success in 21 surgeries in 20 patients with type 3 von Willebrand disease
*IDMC-adjudicated treatment success rating based on hemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none). FVIII: factor VIII
97% of major and minor surgeries
Were managed successfully with wilate®, with no reports of FVIII accumulation in this study3
Median dose per infusion of wilate®
Loading Dose
Maintenance Dose
Mean peak plasma levels post-dosing
Real-world experience
With wilate® in surgery: the WIL-20 study7
WIL-20: Prospective, observational Phase IV study on the use of wilate® in von Willebrand disease
98 surgeries in 62 patients
by VWD type
Type 3
8
13%
Type 2
18
29%
Type 1
35
56%
N/A
1
2%
*Diagnosis data not available
98 surgeries in 62 patients by VWD type
Major Surgeries
46
47%
Minor Surgeries
52
53%
Real-world experience
With wilate® in surgery: the WIL-20 study7
WIL-20: Prospective, observational Phase IV study on the use of wilate® in von Willebrand disease
Excellent or good effectiveness in surgical prophylaxis for*
of 46 major surgeries,
of 52 minor surgeries,
of all surgeries
Effectiveness of wilate® rated as ‘excellent’ or ‘good’ in 99% of surgeries
*IDMC-adjudicated treatment success rating based on hemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none).
Real-world experience
With wilate® in surgery: the WIL-20 study7
Median dose of wilate® per procedure
For Major Surgeries
Range: (22–500 IU/kg)
For Minor Surgeries
Range: (6–680 IU/kg)
Reported in the
WIL-20 study
*Hemostatic effectiveness assessment after surgery using objective 4-point scale (excellent, good, moderate, none). Effectiveness rating not available for one minor surgery.
- 1
Leebeek FWG and Eikenboom JCJ. N Engl J Med 2016; 375:2067–80.
- 2
Miesbach W and Berntorp E. Eur J Haematol 2017; 98:121–27.
- 3
Srivastava A et al. Haemophilia 2017; 23:264–72.
- 4
Windyga J and von Depka-Prondzinski M. Thromb Haemost 2011; 105:1072–9.
- 5
Mannucci PM. N Engl J Med 2004; 351:683–94.
- 6
Kessler CM et al. Thromb Haemost 2011; 106:279–88.
- 7
Sholzberg M et al. TH Open 2021; 5:e264–72.
- 8
Batty P et al. Haemophilia 2014; 20:846–53.
- 9
Khair K et al. Haemophilia 2015; 21:e44–50.
Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate® full Prescribing Information.
Indication
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in adult and pediatric patients with von Willebrand disease for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes. wilate® is also indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes; and for routine prophylaxis to reduce the frequency of bleeding episodes.
Contraindications
Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
- Anaphylaxis and severe hypersensitivity reactions are possible
- Thromboembolic events may occur. Monitor plasma levels of FVIII activity
- Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of wilate®. Test for neutralizing antibodies if plasma VWF and/or Factor VIII level fail to increase as expected or if bleeding is not controlled after wilate® administration
- wilate® is made from human plasma and carries the risk of transmitting infectious agents
Adverse Reactions
The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness. The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).
Please see wilate® full Prescribing Information.
Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate® full Prescribing Information.
Indication
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in adult and pediatric patients with von Willebrand disease for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes. wilate® is also indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes; and for routine prophylaxis to reduce the frequency of bleeding episodes.
Contraindications
Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
- Anaphylaxis and severe hypersensitivity reactions are possible
- Thromboembolic events may occur. Monitor plasma levels of FVIII activity
- Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of wilate®. Test for neutralizing antibodies if plasma VWF and/or Factor VIII level fail to increase as expected or if bleeding is not controlled after wilate® administration
- wilate® is made from human plasma and carries the risk of transmitting infectious agents
Adverse Reactions
The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness. The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).
Please see wilate® full Prescribing Information.
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Please see wilate® full Prescribing Information