VONVENDI® [von Willebrand factor (Recombinant)] Indications & Detailed Important Risk Information
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 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.
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 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.