VONVENDI [von Willebrand factor (Recombinant)] is a recombinant von Willebrand factor (rVWF) indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.1

As the first and only approved prophylaxis treatment for VWD, VONVENDI® [von Willebrand factor (Recombinant)] provides bleed protection

The study calculated median ABR and median percentage change in ABR from 12 months before the study (historical) to 12 months during the study (on-demand).1


A chart showing the median ABR in prior on-demand severe Type 3 von Willebrand Disease patients.
  • ABR=Annualized bleed rate.
  • aBased on descriptive statistics
  • bTreated, untreated, traumatic (due to an injury), or spontaneous (without apparent cause)
  • cTreated or untreated
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Study description

A prospective, single arm, open-label, international multicenter study evaluated the efficacy and safety of VONVENDI in 10 adult patients with severe Type 3 VWD who were previously treated on demand. These participants had ≥3 bleeding episodes (excluding menorrhagia) that required VWF treatment in the 12 months prior to enrolling in the study. Patients began treatment at 50 ± 10 IU/kg per infusion twice weekly. Most patients (9/10) received twice-weekly dosing with VONVENDI and had a median maximum dose of 55.9 IU/kg. One patient required dose adjustments for management of breakthrough bleeding.1,2

The study recorded the number of breakthrough bleeds in severe Type 3 VWD patients who were previously treated on demand (N=10)
  • Breakthrough bleeds refer to the on-study bleeding events (treated and untreated) while on VONVENDI prophylaxis
all bleedsc spontaneous bleedsd joint bleedsc
Number of breakthrough
bleeds in "n" patients1,3,a
38 bleeds in
6 patients
33 bleeds in
5 patients
3 bleeds in
2 patients
Number of patients with
zero breakthrough
4 OF 10 5 OF 10 8 OF 10
  • During the study, most patients (9/10) received twice-weekly dosing with VONVENDI and had a median maximum dose of 55.9 IU/kg1
  • One patient required dose adjustments for management of breakthrough bleeding1
  • This secondary outcomes analysis is based on descriptive statistics and is from a sample size of 10 patients; therefore, results should be interpreted with caution
  • a8 out of 10 prior on-demand severe Type 3 VWD patients completed 12 months of VONVENDI prophylaxis.3
  • bBased on descriptive statistics.
  • cTreated, untreated, traumatic (due to injury), or spontaneous (without apparent cause).1
  • dTreated or untreated.1
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Adjust prophylaxis dose up to 60 IU/kg twice weekly if breakthrough bleeding occurs in joints or if severe bleeding occurs. Treatment of breakthrough bleeds should follow the on-demand dosing guidelines.1
Summary of adverse reactions in patients with VWD from the prophylaxis clinical trial1,a

In the completed prophylaxis clinical study, 22 adult patients aged ≥18 years received prophylactic treatment with VONVENDI. The adverse drug reaction (ADR) terms are listed below:

n (%)b
Nervous System Disorders Headachec 4 (18.2%)
Musculoskeletal and Connective Tissue Disorders Arthralgia 3 (13.6%)
Investigations ALT increased
AST increased
2 (9.1%)
1 (4.5%)
Cardiac Disorders Supraventricular tachycardia
Ventricular extrasystoles
1 (4.5%)
1 (4.5%)
Gastrointestinal Disorders Diarrhea 1 (4.5%)
Skin and Subcutaneous
Tissue Disorders
Rash Pruritic
1 (4.5%)
1 (4.5%)
General Disorders and
Administration Site
Injection site irritation 1 (4.5%)
  • N=Total number of subjects in the Safety Analysis Set within each column.
  • n=Number of subjects who had at least one event in the category.
  • aThese trials were conducted using VONVENDI (recombinant VWF) and, when necessary, rFVIII.
  • bPercentages by subject were calculated using the number of all subjects who had the listed adverse events (AEs).
  • cReported as possibly related by the investigator.

Consider self-infusion with VONVENDI for your patients with VWD

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