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 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% (15/15) for major and minor surgeries (90% CI, 81.9-100)
60%
“Excellent”
(9/15 patients)
5 major surgeries
4 minor surgeries
40%
“Good”
(6/15 patients)
5 major surgeries
1 minor surgery
100% (15/15) for major and minor surgeries (90% CI, 81.9-100)
73.3%
“Excellent”
(11/15 patients)
26.7%
“Good”
(4/15 patients)
Patients with VWD experienced a normal amount of blood loss2
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
Secondary endpoints included1,2:
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
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.
All surgeries (N=15)
67% n=10
33% n=5
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
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.
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).
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 100 subjects treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after total hip replacement surgery.
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.
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 antifactor 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.
In clinical trials, the most common adverse reactions observed in ≥2% of subjects (n=100) were headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, ALT increased and generalized pruritus.
One subject treated with VONVENDI in perioperative setting developed deep vein thrombosis after total hip replacement surgery.
Please see VONVENDI full Prescribing Information.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:
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).
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 100 subjects treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after total hip replacement surgery.
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.
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 antifactor 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.
In clinical trials, the most common adverse reactions observed in ≥2% of subjects (n=100) were headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, ALT increased and generalized pruritus.
One subject treated with VONVENDI in perioperative setting developed deep vein thrombosis after total hip replacement surgery.
Please see VONVENDI full Prescribing Information.![VONVENDI® [von Willebrand factor (Recombinant)] logo.](/dist/images/vonvendi-logo-white.svg){kind=logo}