Established safety profile
The safety profile of VONVENDI® [von Willebrand factor (Recombinant)] was evaluated in 3 prospective, multicenter trials of patients with von Willebrand disease (VWD).4
Summary of adverse reactions in people with VWD4†
|System Organ Class (SOC)||Adverse Reaction||Number of
|Cardiac Disorders||Tachycardia||1 (1.25%)||1 (0.21%)|
|Gastrointestinal Disorders||Vomiting||3 (3.75%)||4 (0.84%)|
|Nausea||3 (3.75%)||3 (0.63%)|
|General Disorders and Administration Site Conditions||Infusion Site Paresthesia||1 (1.25%)||1 (0.21%)|
|Chest Discomfort||1 (1.25%)||1 (0.21%)|
|Skin and Subcutaneous Tissue Disorders||Generalized Pruritus||2 (2.50%)||2 (0.42%)|
|Vascular Disorder||Hot Flush||1 (1.25%)||1 (0.21%)|
|Hypertension||1 (1.25%)||2 (0.42%)|
|Deep Vein Thrombosis||1 (1.25%)||2 (0.42%)|
|Nervous System Disorders||Dizziness||3 (3.75%)||3 (0.63%)|
|Vertigo||2 (2.50%)||3 (0.63%)|
|Dysgeusia||1 (1.25%)||1 (0.21%)|
|Tremor||1 (1.25%)||1 (0.21%)|
|Investigations||Heart Rate Increase||1 (1.25%)||1 (0.21%)|
|Electrocardiogram T Wave Inversions||1 (1.25%)||1 (0.21%)|
†These studies also used a recombinant factor VIII.
‡Percentages by subject were calculated using the number of all subjects who had the listed adverse events, including ALL AEs that are related.
§Total number of unique infusions after which at least one AE was reported of the respective ADR preferred term divided by total number of infusions (N) and multiplied by 100.
Selected Important Risk Information
Side effects that have been reported with VONVENDI include nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, hot flashes, itching, high blood pressure, muscle twitching, unusual taste, blood clots, and increased heart rate.
Tell your healthcare provider about any side effects that bother you or do not go away.
Find out how bleeding episodes were controlled with VONVENDI in clinical studiesSee study results
Get information on proper dosing, and storage & handlingLearn more