Treatment and Control of Bleeds
Established in an On-Demand Clinical Study
100% Treatment Success4,7
In the phase 3, multicenter, open-label clinical study of 18 adults aged 18 to 64 years old, VONVENDI® [von Willebrand factor (Recombinant)] demonstrated 100% treatment success.* The on-demand bleed treatment study duration was 12 months. Treatment success was defined with the use of a rating scale for the treatment of bleeds. The scale measured efficacy as either "Excellent," "Good," "Moderate," or "None." Additionally, its ability to control bleeding was rated “Excellent” in 96.9% of episodes and “Good” in 3.1% of episodes.†
*Participants with GI bleeds and those in whom the number of infusions to control a bleeding episode was estimated retrospectively were excluded.
†Rating scale definitions4
Good: When resolution of minor and moderate bleeding episodes required 1-2 infusions greater than expected or estimated. Or, when resolution of major bleeding episodes was less than 1.5x infusions greater than the estimated number of infusions required to control the bleeding episode.
Ratings of "Excellent" or "Good" required that no additional von Willebrand factor (VWF) coagulation factor-containing product was needed.
Selected Important Risk Information
Your body can form inhibitors to von Willebrand factor or factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop VONVENDI or FVIII from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to von Willebrand factor or factor VIII.
In a variety of locations
VONVENDI [von Willebrand factor (Recombinant)] was shown to control bleeding in the following4:
- Gastrointestinal tract
- Female genital tract
- Mouth and oral cavity
In the clinical study, a median of 1 or 2 infusions WERE required4
In the clinical study, VONVENDI was shown to control 92.6% of mild bleeding episodes (113/122) and 67.2% of moderate bleeding episodes (41/61) experienced by adults with VWD, with just 1 infusion. Severe bleeds were controlled with a median of 2 infusions (n=7). More than half (57.1%; n=4) of people who experienced severe bleeds needed 2 infusions to control the bleed. In one case, 4 doses were needed to control bleeding.
"Half-life" is a term used to descibe how long a treatment stays in the body. In clinical studies, VONVENDI was shown to have, on average, a half-life of 19.1 hours at a dose of 80 IU/kg, and 22.6 hours at a dose of 50 IU/kg.4