VONVENDI® [von Willebrand factor (Recombinant)] is approved to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy.1

Prophylaxis clinical trial 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.1
    • These participants had ≥ 3 bleeding episodes (excluding menorrhagia) that required VWF treatment in the 12 months prior to enrolling in the study.2
  • Patients began treatment at 50 ± 10 IU/kg per infusion twice weekly.1
    • 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

VONVENDI prophylaxis may provide bleed protection for severe Type 3 VWD1

In a clinical trial, routine prophylaxis with VONVENDI helped reduce the number of bleeds for adults with severe Type 3 VWD who were previously treated on-demand (N=10).1

Type or site of bleeding event

AAll bleedsb

SSpontaneous Bleedsc

JJoint Bleedsb

Type or site of
bleeding event
All Bleedsb
Spontaneous Bleedsc
Joint Bleedsb
HISTORICAL MEDIAN
ABRa
(MIN, MAX)
A5.0
(3.0, 159.0)
S3.5
(3.0, 158.0)
J2.0
(0.0, 7.0)
ON-STUDY MEDIAN
ABRa
(MIN, MAX)
A2.3
(0, 157.9)
S1.0
(0.0, 157.9)
J0.0
(0.0, 1.9)
MEDIAN % CHANGE
IN ABR
A-54.7%
S-75.9%
J-100%

a Based on descriptive statistics.

b Includes treated and untreated spontaneous and traumatic bleeding events.

c Includes treated and untreated bleeding events.

Summary of adverse reactions in patients with VWD from the prophylaxis clinical trial1‡

This chart shows the adverse reactions from the completed prophylaxis clinical study (N=22).

These trials were conducted using VONVENDI (recombinant VWF) and, when necessary, a recombinant factor VIII.

Type or site of bleeding event

AAdverse reaction

TTotal (N=22) n(%)a

System Organ Class (SOC)
Adverse Reaction
Total (N=22) n (%)a
System Organ Class (SOC)
Nervous System Disorders
AHeadacheb
T4 (18.2%)
System Organ Class (SOC)
Musculoskeletal and Connective Tissue Disorders
AArthralgia
T3 (13.6%)
System Organ Class (SOC)
Investigations
AALT increased
T2 (9.1%)
AAST increased
T1 (4.5%)
System Organ Class (SOC)
Cardiac Disorders
ASupraventricular tachycardia
T1 (4.5%)
AVentricular extrasystoles
T1 (4.5%)
System Organ Class (SOC)
Gastrointestinal Disorders
ADiarrhea
T1 (4.5%)
System Organ Class (SOC)
Skin and Subcutaneous Tissue Disorders
APurpura
T1 (4.5%)
ARash pruritic
T1 (4.5%)
System Organ Class (SOC)
General Disorders and Administration Site Conditions
AInjection site irritation
T1 (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.

a Percentages by subject were calculated using the number of all subjects who had the listed adverse events (AEs).

b Reported as possibly related by the investigator.

Dosing for prophylaxis

For initiation of prophylactic treatment, administer 40 to 60 IU of VONVENDI per kg of body weight twice weekly. Adjust prophylaxis dose up to 60 IU/kg twice weekly if breakthrough bleeding occurs in joints or if severe bleeding occurs.1

For more information about managing breakthrough bleeds, explore on-demand treatment.

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References: 1. VONVENDI [von Willebrand factor (recombinant)] Prescribing Information. 2. rVWF in prophylaxis. ClinicalTrials.gov identifier: NCT02973087. Updated August 6, 2021. Accessed February 16, 2022. https://clinicaltrials.gov/ct2/show/NCT02973087