![VONVENDI [von Willebrand factor (Recombinant)]](/Content/images/structure/logo-vonvendi.svg){kind=logo}
Range of surgical procedures1,2
In 15 adult patients with severe VWD, VONVENDI, with or without rFVIII, was used to manage perioperative bleeding in a range of major and minor surgical procedures.1,2
may be all you need to manage perioperative bleeding1
Dosing of VONVENDI® [von Willebrand factor (Recombinant)], with or without recombinant factor VIII (rFVIII), should be based on patient need as determined by monitoring levels and clinical judgment.
Dosing of VONVENDI® [von Willebrand factor (Recombinant)], with or without recombinant factor VIII (rFVIII), should be based on patient need as determined by monitoring levels and clinical judgment.
Phase 3 study in adult patients with severe VWD who were undergoing elective surgery1,2
A phase 3 prospective, multicenter, open-label study assessed the efficacy and safety of VONVENDI [von Willebrand factor (Recombinant)] with or without rFVIII in adults (age 18 years and older) diagnosed with severe von Willebrand disease (VWD) of all types undergoing surgery.
Fifteen subjects completed the trial. Ten subjects underwent major surgeries and 5 subjects underwent minor surgeries. All subjects were administered a 12 to 24 hour preoperative Fifteen subjects completed the trial. Ten subjects underwent major surgeries and 5 subjects underwent minor surgeries. All subjects were administered a 12 to 24 hour preoperative dose of 40 to 60 IU/kg of VONVENDI to increase the factor VIII levels to target levels. Within 3 hours prior to surgery, the subjects' FVlll:C levels were assessed to ensure that target of 30 IU/dL for minor surgeries and 60 IU/dL for major surgeries was achieved. Within 1 hour prior to surgery, subjects received a dose of VONVENDI. Recombinant Factor VIII was administered based on FVlll:C levels performed 3 hours prior to surgery. lntraoperative and postoperative dosing were individualized, with or without rFVIII, to maintain target trough levels according to the type of surgery for 14 days.
Primary endpoint was overall hemostatic efficacy
- Assessed by the investigator 24 hours after last perioperative VONVENDI infusion or at completion of day 14 visit, whichever occurred earlier
- Using a 4-point ordinal efficacy scale (“Excellent," “Good," “Moderate,” and “None") based on estimated expected versus actual blood loss, transfusion requirements and postoperative bleeding and oozing
- A rating of Excellent or Good was required to declare the outcome a success
Secondary endpoints included
- Intraoperative hemostatic efficacy as assessed by the operation surgeon
- Intraoperative actual blood loss relative to predicted blood loss
100% (N=15) overall hemostatic efficacy across all types of VWD, for both major and minor surgeries.
Please see Safety profile for study-specific safety information Learn more about the Study Design
Timing of VONVENDI administration in elective surgeries1
In 15 adult patients with severe VWD, VONVENDI, with or without rFVIII, was used to manage perioperative bleeding in a range of major and minor surgical procedures.1,2
100% overall hemostatic efficacy for minor and major surgeries1
In the pivotal, phase 3 surgical study, all 15 participants treated with VONVENDI achieved an overall hemostatic efficacy of 100% (15/15) with a 90% confidence interval (CI) of 81.9% to 100% and intraoperative hemostatic efficacy of 100% with a 90% CI of 81.9% to 100.1
Learn more about the results- Overall and intraoperative results included a 90% CI of 81.9%-100%1
- 9/15 patients achieved "Excellent" efficacy ratings and 6/15 patients achieved "Good" efficacy ratings1
- The clinical trial included patients with all types of VWD, except Type 2N, who were undergoing either major or minor surgeries1,2
Range of surgical procedures1,2
In 15 adult patients with severe VWD, VONVENDI, with or without rFVIII, was used to manage perioperative bleeding in a range of major and minor surgical procedures.1,2
Efficacy was defined as a mean rating score of ≤2, assessed using a 4-point rating scale (Excellent=1, Good=2, Moderate=3, None=4).1
Hemostasis achieved with VONVENDI, with or without recombinant factor VIII (rFVIII), was as good or better than expected for a hemostatically normal patient undergoing the same type of surgery.1
Hemostasis achieved with VONVENDI, with or without rFVIII, was probably as good as expected for a hemostatically normal patient undergoing the same type of surgery.1
1
factor was all most patients needed2,a
10/15 PATIENTS RECEIVED NO CONCOMITANT rFVIII BEFORE, DURING, OR AFTER SURGERY2
| Vonvendi alone | Vonvendi and rFVIIIb | |
| All Surgeries(N=15) | 67% n=10 | 33% n=5 |
| Major Surgeries(n=10) | 70% n=7 | 30% n=3 |
| Minor Surgeries(n=5) | 60% n=3 | 40% n=2 |
1
dose per day was all most patients needed for postoperative bleeding management2,c
- Postoperative bleeding in 12/15 patients was managed by VONVENDI alone2
- 13/15 patients in the study received VONVENDI postoperatively2
- Two patients undergoing minor surgery did not require any postoperative infusions2
aVONVENDI contains only trace amounts of rFVIII.
bOf the 5 patients who did receive concomitant rFVIII, 2 patients received a preoperative infusion (1 infusion each), 2 patients received a postoperative infusion (1 infusion each), and 1 patient received both one preoperative and 6 postoperative infusions.
cTwo patients undergoing major surgery required more frequent dosing of VONVENDI.
Register For Updates
Stay up to date with the latest news and information
Safety Data
Find out about frequency of observed adverse events and the overall safety profile of VONVENDI
Contact a Takeda Rep
Get in touch with a Takeda representative in your area
Reference: 1. VONVENDI [von Willebrand factor (recombinant)] Prescribing Information. 2. Peyvandi F, Mamaev A, Wang JD, et al. Phase 3 study of recombinant von Willebrand factor in patients with severe von Willebrand disease who are undergoing elective surgery. J Thromb Haemost. 2019;17(1):52-62.
