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
*The indicated use is for prevention and treatment of hemorrhage 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.
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 haemostatic 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 haemostatic 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 children and adults 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 in children 6 years of age and older and adults with VWD. wilate® is also indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and for on-demand treatment and control of bleeding episodes.
Contraindications
wilate® is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
Hypersensitivity Reactions
Hypersensitivity reactions may occur with wilate®. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving wilate® and observe for any symptoms throughout the infusion period.
Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors.
Thromboembolic Events
In VWD, continued treatment using a FVIII-containing VWF product may cause an excessive rise in FVIII activity, which may increase the risk of thromboembolic events. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels.
Neutralizing Antibodies
VWD
- Neutralizing antibodies (inhibitors) to FVIII and VWF in patients with VWD, especially type 3 patients, may occur. If a patient develops inhibitor to VWF (or to FVIII), the condition will manifest itself as an inadequate clinical response. Thus, if expected VWF activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, perform an appropriate assay to determine whether a VWF inhibitor is present.
- In patients with antibodies against VWF, VWF is not effective and wilate® administration may lead to severe adverse events. Consider other therapeutic options for such patients.
Hemophilia A
- Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage clotting assay), to confirm that adequate Factor VIII levels have been achieved and maintained.
- Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained, or if bleeding is not controlled with the expected dose of wilate®. Use Bethesda Units (BU) to report inhibitor levels.
Transmissible Infectious Agents
wilate® is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that wilate® will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, it may still potentially transmit disease.
Record the batch number of the product every time wilate® is administered to a patient, and consider appropriate vaccination (against hepatitis A and B virus) of patients in regular/repeated receipt of wilate®. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Octapharma USA, Inc., at 1-866-766-4860.
Monitoring and Laboratory Tests
- Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thromboembolism, particularly in patients with known clinical or laboratory risk factors.
- Monitor for development of VWF and FVIII inhibitors. Perform assays to determine whether VWF and/or FVIII inhibitor(s) is present if bleeding is not controlled with the expected dose of wilate®.
Adverse Reactions
The most common adverse reactions to treatment with wilate® (≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, chest discomfort and dizziness. The most common adverse reactions to treatment with wilate® (≥ 1%) in previously treated patients with 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 children and adults 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 in children 6 years of age and older and adults with VWD. wilate® is also indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and for on-demand treatment and control of bleeding episodes.
Contraindications
wilate® is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
Hypersensitivity Reactions
Hypersensitivity reactions may occur with wilate®. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving wilate® and observe for any symptoms throughout the infusion period.
Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors.
Thromboembolic Events
In VWD, continued treatment using a FVIII-containing VWF product may cause an excessive rise in FVIII activity, which may increase the risk of thromboembolic events. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels.
Neutralizing Antibodies
VWD
- Neutralizing antibodies (inhibitors) to FVIII and VWF in patients with VWD, especially type 3 patients, may occur. If a patient develops inhibitor to VWF (or to FVIII), the condition will manifest itself as an inadequate clinical response. Thus, if expected VWF activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, perform an appropriate assay to determine whether a VWF inhibitor is present.
- In patients with antibodies against VWF, VWF is not effective and wilate® administration may lead to severe adverse events. Consider other therapeutic options for such patients.
Hemophilia A
- Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage clotting assay), to confirm that adequate Factor VIII levels have been achieved and maintained.
- Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained, or if bleeding is not controlled with the expected dose of wilate®. Use Bethesda Units (BU) to report inhibitor levels.
Transmissible Infectious Agents
wilate® is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that wilate® will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, it may still potentially transmit disease.
Record the batch number of the product every time wilate® is administered to a patient, and consider appropriate vaccination (against hepatitis A and B virus) of patients in regular/repeated receipt of wilate®. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Octapharma USA, Inc., at 1-866-766-4860.
Monitoring and Laboratory Tests
- Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thromboembolism, particularly in patients with known clinical or laboratory risk factors.
- Monitor for development of VWF and FVIII inhibitors. Perform assays to determine whether VWF and/or FVIII inhibitor(s) is present if bleeding is not controlled with the expected dose of wilate®.
Adverse Reactions
The most common adverse reactions to treatment with wilate® (≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, chest discomfort and dizziness. The most common adverse reactions to treatment with wilate® (≥ 1%) in previously treated patients with hemophilia A was pyrexia (fever).
Please see wilate® full Prescribing Information.
You Are Now Leaving wilateusa.com
Octapharma does not review, endorse, or control the content of any non-Octapharma site. Octapharma is not responsible for the accuracy, content, practices, or standards of any non-Octapharma resources accessed through a link on this site. Octapharma provides general information for educational purposes. This site does not provide medical advice, diagnosis, or treatment to you. Always consult your physician to help decide a treatment plan or other medical advice.
FOR U.S. HEALTHCARE PROFESSIONALS ONLY
The information on this website has been specifically created for U.S. healthcare professionals (HCPs)
Please see wilate® full Prescribing Information