Intended for US Healthcare Professionals Only

Need for Effective On-Demand Treatment

In von Willebrand disease6,7

People with von Willebrand disease can be susceptible to spontaneous and traumatic bleeding, including:

Nosebleeds
Abnormal Bruising
Gum Bleeds
Joint Bleeds
Gastrointestinal Bleeds
Heavy Menstrual Bleeding
Muscle Bleeds
Heavy bleeding during or child after childbirth

The efficacy of wilate®

For on-demand treatment of bleeds has been demonstrated in clinical trials in adults and children with all types of von Willebrand disease2

Data from four prospective, Phase II and III trials

Patients by von Willebrand disease type

Type 3
21
70%
Type 2
2
7%
Type 1
7
23%

wilate® efficacy rated ‘excellent’ or ‘good’

of 1095 treated bleeding events

Type of bleeding event*

Joint
52%
Epistaxis
9%
Gastrointestinal
13%
Oral
3%
Heavy Menstrual Bleeding
6%
Other
18%

On-demand treatment of bleeds is supported by data from
real-world studies

WIL-20: Non-interventional Phase IV study3

WIL-20 included 111 patients (aged 1 to 83 years) at 31 centers. 29 patients were treated on-demand
with wilate®

wilate® efficacy rated ‘excellent’
or ‘good’ in

of 127 treated bleeding events*

*as rated by the investigator

For on-demand treatment of bleeds is supported by data from
real-world studies

Real-world retrospective studies

wilate® efficacy rated ‘excellent’ or ‘good’

of 46 bleeding events in 25 adults (median age 42 years, range 19–82 years)4

of 44 bleeding events in 15 adolescents
and children (median age 7 years, range 0–17 years)5

  • 1

    de Wee EM et al. Thromb Haemost 2012; 108:683–92.

  • 2

    Berntorp E et al. Haemophilia 2009; 15:122–30.

  • 3

    Sholzberg M et al. TH Open 2021; 5:e264–72.

  • 4

    Batty P et al. Haemophilia 2014; 20:846–53.

  • 5

    Miesbach W and Berntorp E. Thromb Res 2021; 199:67–74.

  • 6

    Khair K et al. Haemophilia 2015; 21:e44–50.

  • 7

    Lillicrap D and James P. WFH Treatment of Hemophilia 2009; No. 47 (available at this link)

  • 8

    Castaman G et al. Haematologica 2013; 98:667–74.

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.

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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

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© 2025 Octapharma USA, Inc. All rights reserved WIL-0678.