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 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.1
VONVENDI was used for pharmacokinetic assessment and on-demand and perioperative management of bleeding episodes in patients with VWDa:
| SYSTEM ORGAN CLASS | ADVERSE REACTION | TOTAL (N=80) n (%)b |
|---|---|---|
| Cardiac Disorders | Tachycardia | 1 (1.25%) |
| Gastrointestinal Disorders | Vomiting Nausea |
3 (3.75%) 3 (3.75%) |
| General Disorders and Administration Site Conditions |
Infusion site paresthesia Chest discomfort |
1 (1.25%) 1 (1.25%) |
| Skin and Subcutaneous Tissue Disorders |
Generalized pruritus | 2 (2.50%) |
| Vascular Disorders | Hot flush Hypertension Deep vein thrombosis |
1 (1.25%) 1 (1.25%) 1 (1.25%) |
| Nervous System Disorders | Dizziness Vertigo Dysgeusia Tremor |
3 (3.75%) 2 (2.50%) 1 (1.25%) 1 (1.25%) |
| Investigations | Heart rate increase Electrocardiogram T wave inversions |
1 (1.25%) 1 (1.25%) |
aThese trials were conducted using VONVENDI (recombinant VWF) and, when necessary, rFVIII.
bPercentages by subject were calculated using the number of all subjects who had the listed adverse events (AEs), including all AEs that are related.
A single patient treated with VONVENDI in a clinical trial developed an infusion-related reaction. This patient was previously exposed to VONVENDI without any symptoms. They developed chest discomfort and increased heart rate 3 minutes after the infusion was started. The patient was treated with supportive care and symptoms were resolved in 3 hours.1
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 belowa:
| 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%) |
N=Total number of subjects in the Safety Analysis Set within each column.
n=Number of subjects who had at least one event in the category.
aThese trials were conducted using VONVENDI (recombinant VWF) and, when necessary, rFVIII.
bPercentages by subject were calculated using the number of all subjects who had the listed adverse events (AEs).
cReported as possibly related by the investigator.
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}