Intended for US Healthcare Professionals Only

Take control of von Willebrand disease

wilate® is a VWF/FVIII complex 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 a high-purity plasma-derived von Willebrand factor and coagulation factor VIII (VWF/FVIII) complex

wilate® was developed specifically for people with von Willebrand disease (VWD), and contains VWF and 
FVIII in a physiological 1:1 activity ratio, which may facilitate simple dosing and monitoring even when repeated dosing is needed.4,5

The purification process includes two virus inactivation steps in order to help ensure a high-purity product free
of viral contamination.4

Over 15 years of clinical and real-life experience have proven the efficacy and tolerability of wilate® in people with all types of von Willebrand disease for surgery, on-demand treatment and prophylaxis.1-3

*Based on von Willebrand factor and factor VIII activity levels. FVIII, coagulation factor VIII; VWF, von Willebrand factor.

wilate® is indicated in children and adults with von Willebrand disease for:

On-demand treatment and control of bleeding episodes
Perioperative
management
of bleeding
Routine prophylaxis
in children 6 years
of age and older
and adults with von Willebrand Disease

Physiological 1:1 ratio of VWF and FVIII in wilate®

One of the functions of VWF is to bind to and protect FVIII from proteolytic degradation4

As a result, people with von Willebrand disease may have low levels of both VWF and FVIII, both of which need to be corrected in order to restore normal hemostasis.4

wilate® contains VWF and FVIII in a balanced 1:1 ratio*, which is similar to the activity ratio of VWF and FVIII in the plasma of healthy individuals4

*Based on von Willebrand factor and factor VIII activity levels.

Physiological 1:1 ratio of VWF and FVIII in wilate®

One of the functions of VWF is to bind to and protect FVIII from proteolytic degradation4

As a result, people with von Willebrand disease may have low levels of both VWF and FVIII, both of which need to be corrected in order to restore normal hemostasis.4

The balanced ratio of VWF and FVIII* may simplify dosing and monitoring of wilate®2

*Based on von Willebrand factor and factor VIII activity levels.

Manufacturing of wilate®

wilate® is a high-purity, human VWF/FVIII complex

wilate® is made from pooled human plasma that has been collected in GMP-compliant donation centers.

All individual plasma samples undergo extensive testing for viruses, including for HIV, hepatitis A, B and C and parvovirus B199,10

FVIII, factor VIII; GMP, good manufacturing practice; HIV, human immunodeficiency virus; VWF, von Willebrand factor.

wilate® is purified through a series of carefully controlled processing steps, all designed to minimize impurities and ensure viral safety4

Two chromatographic steps ensure high purity and remove non-essential proteins4

Viral safety is achieved by two complementary virus inactivation steps4

Manufacturing of wilate®

wilate® is a high-purity, human VWF/FVIII complex

Manufacturing of wilate®

wilate® is a high-purity, human VWF/FVIII complex

Solvent/detergent treatment4, 11, 12

A proven and established method used widely in the purification of products made from
human plasma
Effective against enveloped viruses, such as HIV, HBV, HCV and West Nile Virus
Inactivates viruses by breaking down the outer layer that surrounds them

Terminal dry heat treatment 
(PermaHeat)4, 11, 12

Developed to supplement the solvent/detergent process
 
Effective against a broad spectrum of both enveloped and non-enveloped viruses
Uses dry heat (>100°C, for 2 hours) to inactivate viruses

HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus.

Manufacturing of wilate®

wilate® is a high-purity, human VWF/FVIII complex

Intact triplet structure of individual multimers | wilate | SHP | 1st Generation | Enhanced proteolysis: pronounced faster migrating band

The manufacturing process of wilate® preserves the structure and multimer distribution of VWF seen in the plasma of healthy individuals4

Figure adapted from Windyga et al. 2011 SHP, standard human plasma.

Size exclusion chromatography

One of the steps in the wilate® purification process is called size exclusion chromatography. This step minimizes impurities and helps reduce the risk of side effects.1,3 When the results of the advanced size exclusion chromatography are analyzed, wilate® shows a single peak (see figure) containing only the native (natural) VWF/FVIII complex.3

wilate shows a single peak containing only the native (natural) VWF/FVIII complex
Competitor Graphic

No albumin is added to wilate®. Added plasma proteins may cause clinical side effects

  • 1

    Srivastava A et al. Haemophilia 2017; 23:264–72.

  • 2

    Windyga J and von Depka-Prondzinski M. Thromb Haemost 2011; 105:1072-9.

  • 3

    Berntorp E and Windyga J. Haemophilia 2009; 15:122–30.

  • 4

    Stadler M et al. Biologicals 2006; 34:281–8.

  • 5

    Kessler CM et al. Thromb Haemost 2011; 106:279–88.

  • 6

    wilate® Full Prescribing Information. Paramus, NJ: Octapharma; rev November 2024.

  • 7

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

  • 8

    Octapharma AG, data on file.

  • 9

    Link: Octapharma Quality and Safety, last accessed July 2021.

  • 10

    Link: Octapharma Production Process. last accessed July 2021.

  • 11

    Biesert L and Suhartano H. Vox Sang 1998; 74(Suppl.1):207-12.

  • 12

    Teitel JM. Ann Med 2000; 32:485-92.

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

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

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