Intended for US Healthcare Professionals Only

Wilate®: Complete VWD Indication Profile Including Prophylaxis for All Patient Types and Ages

Wilate® is the ONLY Available VWF Product Approved for Routine Prophylaxis across the full VWD population8,9,10

On Demand Surgery Prophylaxis
Adult
18+ Years		 Children
6-17 Years		 Pediatric
<6 Years		 Adult
18+ Years		 Children
6-17 Years		 Pediatric
<6 Years		 Adult
18+ Years		 Children
6-17 Years		 Pediatric
<6 Years
wilate®
Humate-P®
Alphanate®
Vonvendi®

Presentation of Vonvendi®, Humate-P®, and Alphanate® information is not intended to claim or imply inferiority, equivalence, or superiority to wilate® in efficacy, safety, or other conditions of use. Vonvendi® is a registered trademark of Takeda. Humate-P® is a registered trademark of CSL Behring GmbH. Alphanate® is a registered trademark of Grifols.

Well-Researched Efficacy and Tolerability

The benefits of prophylaxis with wilate® were analyzed in two recent research studies, WIL-314 and WIL-336.

These studies assessed efficacy in bleed management and tolerability of prophylaxis with wilate® in patients over and under 6 years of age, respectively. They found:

wilate® prophylaxis reduced bleeding in participants 6 years and older in WIL-3164

REDUCTION IN TOTAL BLEEDING4
Total ABR: 33.4 → 5.2
  • 87% fewer spontaneous bleeds (ABR: 24.4→3.2)
  • 1 in 3 participants had 0 total bleeds
  • 70% of participants were maintained on twice-weekly dosing

wilate® prophylaxis demonstrated low bleeding rates in children under 6 years in WIL-335,6

MEAN TOTAL ABR
(per-protocol set)11,a
Mean spontaneous ABR: 1.06
  • 95.6% of treated bleeds resolved with one infusion6
  • 98.2% of bleeds were minor6

Long-term prophylaxis with wilate® was well-tolerated4,5

No thrombotic
events

No serious
treatment-emergent
adverse events
related to wilate®

No VWF or FVIII
accumulation
over 12 months

No participants
developed inhibitors
to VWF or FVIII
during the study

Reduced Bleeding across All Sites

Prophylaxis with wilate® has been shown to reduce all types of bleeding vs prior on-demand treatment4

Reduction in Bleeds

Mucosal
Nose 76%
Oral 85%
Heavy menstrual 80%
Muscle
Arm 98%
Leg 97%
Hemarthrosis (Joints)
Joints 93%
Ankle 93%
Knee 98%
Elbow 90%

Reduced Bleeding across All Types of VWD

wilate® prophylaxis led to a reduction in mean total ABR vs on-demand treatment in all types of VWD

*Sidonio RF Jr, Boban A, Dubey L, et al. Blood Adv. 2024;8(6):1405-1414.

Reduced Bleeding in Heavy Menstrual Bleeding

In an exploratory analysis, wilate® prophylaxis given 2 to 3 times per week—
not timed to menstruation—reduced heavy menstrual bleeding11,a

  • reduction in mean heavy menstrual ABR (9.7 → 2.4)
  • reduction in PBAC scores, a measure of menstrual blood loss (227 → 131)b

a PExploratory analysis in 5 female patients of childbearing age (13–43 years) in WIL-29 (on-demand) and WIL-31 (prophylaxis). Patients had comorbidities that may have affected menstrual health.

b Patients had comorbidities that may have affected menstrual health.

c PBAC ≥185 correlates with HMB (>80 mL menstrual blood loss).

Ongoing Increase in Bleed Control

With wilate® prophylaxis, improvement in bleeding control builds over time.4,5

Reductions in bleeding continued across a full year of prophylaxis, across all age groups.4,5 The longer patients stayed on prophylaxis, the greater the improvement in bleeding control.4,5

Mean total ABR: first 6 months vs second 6 months, by age group4,5

a Two participants prematurely terminated before the start of the second 6-month subperiod and were excluded.

ABR=annualized bleeding rate; VWD=von Willebrand disease; VWF=von Willebrand factor.

Protection Beyond Bleeding

The benefits of prophylaxis with wilate® reach well beyond bleed management2.

Emerging research suggests that VWF also plays a role in supporting the endothelium and keeping it strong. Over time, inadequate levels of VWF can weaken bleed vessels, making them fragile. This fragility can contribute to recurrent bleeding and companion problems: iron deficiency, a serious condition that often goes unrecognized and undertreated,2 and a higher disease burden with increased hospitalizations and chronic pain7.

Prophylaxis with wilate® may help VWD patients avoid these consequences.2,7

The longer patients stayed on prophylaxis, the greater the improvement in bleeding control.4,11

  • 1

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

  • 2

    Connell NT et al. Blood Adv 2021; 5:301–25.

  • 3

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

  • 4

    Sidonio RF Jr, Boban A, Dubey L, et al. Blood Adv. 2024;8(6):1405-1414.

  • 5

    Jain A, et al. WIL-33 by-period ABR durability data. Manuscript pending publication.

  • 6

    Jain A, Leissinger C, Vdovin V, et al. Blood. 2025;146(suppl 1):4855-4856.

  • 7

    Du P, Morgan G, Brighton S, Sun SX. Clin Appl Thromb Hemost. 2022;28:10760296221130334.

  • 8

    Vonvendi® Prescribing Information. Takeda Pharmaceuticals; September 2025.

  • 9

    Humate-P® Prescribing Information. CSL Behring; June 2020.

  • 10

    Alphanate® Prescribing Information. Grifols Biologics; November 2022.

  • 11

    Kiss C, Boda Z, Khayat CD, Boban A, Dubey L, Sidonio RF Jr. AJOG Glob Rep. 2025;5(2):100501.

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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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

© 2026 Octapharma USA, Inc. All Rights Reserved WIL-0811.

© 2026 Octapharma USA, Inc. All Rights Reserved WIL-0811.