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
Administer 40 to 60 IU of VONVENDI per kg of body weight twice weekly for initiation of prophylactic treatment
Consider self-infusion with VONVENDI for your
patients with VWD
VONVENDI enables healthcare providers to manage von Willebrand factor (VWF) and FVIII levels separately and specifically, based on patient need1,b,c
For the first dose, administer VONVENDI alone if FVIII:C level is ≥40% or if an immediate rise in FVIII:C is not necessary.
| Hemorrhagic event | Initial doseb | Subsequent dose |
| Minor (eg, readily managed epistaxis, oral bleeding, menorrhagia) |
40 to 50 IU/kg | 40 to 50 IU/kg every 8 to 24 hours (as clinically required) |
|
Majorc (eg, severe or refractory epistaxis, menorrhagia, gastrointestinal [GI] bleeding, central nervous system [CNS] trauma, hemarthrosis, or traumatic hemorrhage) |
50 to 80 IU/kg | 40 to 60 IU/kg every 8 to 24 hours for approximately 2 to 3 days (as clinically required) |
If the FVIII:C level is <40%, or is unknown, administer VONVENDI with rFVIII to help control bleeding. The rFVIII dose should be calculated according to the difference between the patient's baseline plasma FVIII:C level and the desired peak FVIII:C level to achieve an appropriate plasma FVIII:C level based on the approximate mean recovery of 2% (IU /kg). Administer the complete dose of VONVENDI followed by rFVIII within 10 minutes.1
Learn about the endogenous rise in FVIII levels following VONVENDI infusion.
Consider prophylaxis for your appropriate adult
patients receiving on-demand therapy
VONVENDI may be administered to allow endogenous FVIII levels to increase
| Minimum FVIII:C target levels |
|
30% FOR MINOR SURGERY
60% FOR MAJOR SURGERY
|
| Baseline FVIII:C, VWF:RCo, IRc | Target Peak Plasma Levels | |||||
| Known | Unknown | |||||
| Type of Surgery | Calculation of VONVENDI Dose (IU VWF:RCo required) |
VWF:RCo [IU VWF:RCo/ kgBW] |
FVIII:C (IU FVIII:C/ kgBW] |
VWF:RCo FVIII:Cd | ||
| Minor |
VWF:RCo Target Peak − VWF:RCo Baseline X BW (kg) IR |
25 to 30 IU/kg
|
20 to 25 IU/kg
|
50% to 60%
|
40% to 50%
|
|
| Major |
50 ± 10 IU/kg
|
40 to 50 IU/kg
|
100%
|
80% to 100%
|
||
Dosing of VONVENDI, with or without rFVIII, should be based on patient need as determined by monitoring levels and clinical judgment.1
|
VWF:RCo Minimum Target Plasma Level |
FVIII:C Minimum Target Plasma Level |
Minimum Duration of Treatment | Frequency of Dosing | ||||
| Type of Surgery | Up to 72 hours post surgery |
After 72 hours post surgery |
Up to 72 hours post surgery |
After 72 hours post surgery |
|||
| Minor | ≥30% | — | >30% | — | 48 hours |
Every 12-24 hours to every other day |
|
| Major | >50% | >30% | >50% | >30% | 72 hours |
||
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}