FOR YOUR SEVERE TYPE 3 VON WILLEBRAND DISEASE (VWD) PATIENTS RECEIVING ON-DEMAND THERAPY1
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
The study calculated median ABR and median percentage change in ABR from 12 months before the study (historical) to 12 months during the study (on-demand).1
MEDIAN ABR IN PRIOR ON-DEMAND SEVERE TYPE 3 VWD PATIENTS1
A prospective, single arm, open-label, international multicenter study evaluated the efficacy and safety of VONVENDI in 10 adult patients with severe Type 3 VWD who were previously treated on demand. These participants had ≥3 bleeding episodes (excluding menorrhagia) that required VWF treatment in the 12 months prior to enrolling in the study. Patients began treatment at 50 ± 10 IU/kg per infusion twice weekly. Most patients (9/10) received twice-weekly dosing with VONVENDI and had a median maximum dose of 55.9 IU/kg. One patient required dose adjustments for management of breakthrough bleeding.1,2
| all bleedsc | spontaneous bleedsd | joint bleedsc | |
|---|---|---|---|
| Number of breakthrough bleeds in "n" patients1,3,a |
38 bleeds in 6 patients |
33 bleeds in 5 patients |
3 bleeds in 2 patients |
| Number of patients with zero breakthrough bleeds3,a,b |
4 OF 10 | 5 OF 10 | 8 OF 10 |
In the completed prophylaxis clinical study, 22 adult patients aged ≥18 years received prophylactic treatment with VONVENDI. The adverse drug reaction (ADR) terms are listed below:
| SYSTEM ORGAN CLASS | ADVERSE REACTION | TOTAL (N=22) n (%)b |
|---|---|---|
| Nervous System Disorders | Headachec | 4 (18.2%) |
| Musculoskeletal and Connective Tissue Disorders | Arthralgia | 3 (13.6%) |
| Investigations | ALT increased AST increased |
2 (9.1%) 1 (4.5%) |
| Cardiac Disorders | Supraventricular tachycardia Ventricular extrasystoles |
1 (4.5%) 1 (4.5%) |
| Gastrointestinal Disorders | Diarrhea | 1 (4.5%) |
| Skin and Subcutaneous Tissue Disorders |
Purpura Rash Pruritic |
1 (4.5%) 1 (4.5%) |
| General Disorders and Administration Site Conditions |
Injection site irritation | 1 (4.5%) |
Consider self-infusion with VONVENDI for your patients with VWD
See patient resources
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}