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

100% overall hemostatic efficacy for both major and minor surgeries in a pivotal surgical trial1
All 15 participants treated with VONVENDI with or without rFVIII had hemostatic efficacy ratings of “Excellent” or “Good”1
Overall hemostatic efficacy (rated by the investigator)1

100% (15/15) for major and minor surgeries (90% CI, 81.9-100)


(9/15 patients)
5 major surgeries
4 minor surgeries

Pie chart showcasing 60% and 40% parts.


(6/15 patients)
5 major surgeries
1 minor surgery

Intraoperative hemostatic efficacy (rated by the surgeon)1

100% (15/15) for major and minor surgeries (90% CI, 81.9-100)


(11/15 patients)

Pie chart showcasing 73.3% and 26.7% parts.


(4/15 patients)

Patients with VWD experienced a normal amount of blood loss2

  • Predicted blood loss in hemostatically normal patients (average [SD]): 106 mL (162) [n=14])
  • Actual blood loss in patients treated with VONVENDI (average [SD]): 94 mL (178 [n=15])
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Study description

A prospective, multicenter, open-label study assessed the efficacy and safety of VONVENDI with or without rFVIII in adults (age 18 years and older) diagnosed with severe VWD of all types undergoing elective surgical procedures. Patients received 40 to 60 IU/kg of VONVENDI 12 to 24 hours before surgery, followed by VONVENDI with or without rFVIII within 1 hour of surgery, and postoperatively, as needed. Dosing of VONVENDI with or without rFVIII was based on monitoring of FVIII:C levels and clinical judgment.1,2

Primary endpoint

  • Overall hemostatic efficacy assessed by the investigator 24 hours after last perioperative VONVENDI infusion or at completion of day 14 visit, whichever occurred earlier1

Secondary endpoints included1,2:

  • Intraoperative hemostatic efficacy as assessed by the operating surgeon
  • Intraoperative actual blood loss relative to predicted blood loss

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
Excellent: 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.
Good: 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.

VONVENDI was all most patients needed to manage surgical bleedinga

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

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1 dose per day was all most patients needed for postoperative bleeding management.c 13/15 patients in the trial received VONVENDI postoperatively3d

a VONVENDI contains only trace amounts of rFVIII.1

b Of the 5 patients who did receive concomitant rFVIII, 2 patients received a preoperative infusion (1 infusion each), 1 patient received an intraoperative infusion, 1 patient received a postoperative infusion, and 1 patient received both 1 preoperative and 6 postoperative infusions. Only 2 out of a total of 11 infusions in these 5 patients were performed when the FVIII:C level was actually below a protocol-defined target level.3

c Three patients undergoing major surgery required more frequent dosing of VONVENDI.3

d Two patients undergoing minor surgery did not require any postoperative infusions.3

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VONVENDI surgical adverse events3
Treatment-emergent adverse events were reported in 6 patients

11 of 12 adverse events were considered unrelated to treatment: acne, anemia, deep vein thrombosis (DVT), diverticulitis, dizziness, dry skin, headache, joint swelling, nasopharyngitis, pelvic pain, and peripheral swelling.

One DVT event considered possibly related to VONVENDI was managed throughout the postoperative period; it subsequently resolved.