Surgery

Surgery poses a serious risk of bleeding in people with von Willebrand disease and necessitates careful monitoring and management.1


Normalising the activity of both von Willebrand factor and factor VIII is important to maintain haemostasis during surgery to minimise the risk of prolonged or excessive bleeding.1, 2 The efficacy of wilate® for surgical prophylaxis has been demonstrated in clinical trials and is supported by real-world experience for major and minor surgeries, in patients with all types of VWD. There have been no reports of thromboembolism or factor VIII accumulation in any clinical study of wilate®.3, 4

Requirements for managing surgery

in people with von Willebrand disease

Normalisation of both VWF and FVIII to ensure normal haemostasis1

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

VWF and FVIII in wilate®

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*

* the indicated use is for prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated. FVIII:C: FVIII clotting activity; VWF:RCo: VWF Ristocetin Cofactor.

Parallel decay of VWF:RCo and FVIII:C

May simplify dosing and monitoring using either VWF or FVIII

VWF and FVIII in wilate®

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*

_2-3_4@2x

* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII:C: FVIII clotting activity; FVIII: factor VIII, VWF: von Willebrand factor; VWF:Ag: von Willebrand factor Antigen; VWF:RCo: VWF Ristocetin Cofactor

VWF and FVIII in wilate®

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*

_2-3_5@2x

Representative recovery profile in an 18 year old female patient with type 3 von Willebrand disease undergoing leg elongation surgery4

 

No FVIII accumulation seen despite repeat dosing4

* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII:C: FVIII coagulation activity; FVIII: factor VIII and VWF: von Willebrand factor; VWF:RCo: VWF ristocetin cofactor.

VWF and FVIII in wilate®

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*

* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII: factor VIII; VWD: von Willebrand disease

reported in any clinical study or published real-world clinical experience3, 4, 7–9

97% of major & minor surgeries

were managed successfully with wilate®, with no reports of thromboembolism or FVIII accumulation in any clinical study3

WONDERS: Prospective, open-label, uncontrolled Phase III study of wilate® in surgery

_2-3_7@2x

FVIII: factor VIII

_2-3_7_@2x

97% of major & minor surgeries

were managed successfully with wilate®, with no reports of thromboembolism or FVIII accumulation in any clinical study3

Overall efficacy rated as successful* in 97% of surgeries

* IDMC-adjudicated treatment success rating based on haemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none). FVIII: factor VIII

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

97% of major & minor surgeries

were managed successfully with wilate®, with no reports of thromboembolism or FVIII accumulation in any clinical study3

Median dose per infusion of wilate®

Loading dose

Maintenance dose

97% of major & minor surgeries

were managed successfully with wilate®, with no reports of thromboembolism or FVIII accumulation in any clinical study3

FVIII: factor VIII

97% of major & minor surgeries

were managed successfully with wilate®, with no reports of thromboembolism or FVIII accumulation in any clinical study3

*0 = pre-surgery loading dose. Error bars represent standard error of the mean. FVIII: factor VIII; FVIII:C: FVIII coagulation activity; VWF:Ag: VWF antigen; VWF:RCo: VWF ristocetin cofactor.

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

_2-3_12_@2x

*Diagnosis data not available.

_2-3_12@2x

Real-world experience

with wilate® in surgery: the WIL-20 study7

Excellent or good effectiveness in surgical prophylaxis for*

* IDMC-adjudicated treatment success rating based on haemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none).

of 46 major surgeries

of 52 minor surgeries

Effectiveness of wilate® rated as ‘excellent’ or ‘good’ in 99% of surgeries

of all surgeries

Real-world experience

with wilate® in surgery: the WIL-20 study7

Median dose of wilate® per procedure

*Haemostatic effectiveness assessment after surgery using objective 4-point scale (excellent, good, moderate, none). Effectiveness rating not available for one minor surgery.

for major surgeries range: (22–500 IU/kg)

for minor surgeries
range: (6–680 IU/kg)

Reported in the WIL-20 study

Information about on-demand treatment with wilate®

Treat on-demand

Prevention of bleeding with wilate®

Prophylaxis

Use of wilate® in people with von Willebrand disease

Tolerability

References

  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.