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.
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
Secondary endpoints included
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 DesignRange 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
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
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 resultsRange 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
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
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.
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Indications
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:
Detailed Important Risk Information
CONTRAINDICATIONS
Do not use in patients who have had life-threatening hypersensitivity reactions to VONVENDI or its components (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins).
WARNINGS AND PRECAUTIONS
Embolism and Thrombosis
Thromboembolic reactions, including disseminated intravascular coagulation, venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, can occur, particularly in patients with known risk factors for thrombosis, including low ADAMTS13 levels. Monitor for early signs and symptoms of thrombosis such as pain, swelling, discoloration, dyspnea, cough, hemoptysis, and syncope, and institute prophylaxis measures against thromboembolism based on current recommendations.
In patients requiring frequent doses of VONVENDI in combination with recombinant factor VIII, monitor plasma levels for FVIII:C activity because sustained excessive factor VIII plasma levels can increase the risk of thromboembolic events.
One out of 80 subjects treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after total hip replacement surgery.
Hypersensitivity Reactions
Hypersensitivity reactions have occurred with VONVENDI. These reactions can include anaphylactic shock, generalized urticaria, angioedema, chest tightness, hypotension, shock, lethargy, nausea, vomiting, paresthesia, pruritus, restlessness, blurred vision, wheezing and/or acute respiratory distress. Discontinue VONVENDI if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing Antibodies (Inhibitors)
Inhibitors to VWF and/or factor VIII can occur. If the expected plasma levels of VWF activity (VWF:RCo) are not attained, perform an appropriate assay to determine if anti-VWF or anti-factor VIII inhibitors are present. Consider other therapeutic options and direct the patient to a physician with experience in the care of either VWD or hemophilia A.
In patients with high levels of inhibitors to VWF or factor VIII, VONVENDI therapy may not be effective and infusion of this protein may lead to severe hypersensitivity reactions. Since inhibitor antibodies can occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors.
ADVERSE REACTIONS
In clinical trials, the most common adverse reactions observed in ≥2% of subjects (n=80) were generalized pruritus, vomiting, nausea, dizziness, and vertigo.
One subject treated with VONVENDI in perioperative setting developed deep vein thrombosis after total hip replacement surgery.
Please see VONVENDI full Prescribing Information.