Established safety profile
The safety profile of VONVENDI® [von Willebrand factor (Recombinant)] was evaluated in 3 prospective, multicenter trials4:
Two of the safety trials were conducted in adults age 18 and over with von Willebrand disease (n=66), and 1 was conducted in participants with hemophilia A (n=12). The adverse reactions reported in the 2 von Willebrand disease trials are listed in the table below.
Summary of adverse reactions in people with VWD4†
|System Organ Class (SOC)||Adverse Reaction||Number of
|Cardiac Disorders||Tachycardia||1 (1.52%)||1 (0.28%)|
|Gastrointestinal Disorders||Nausea||1 (1.52%)||1 (0.28%)|
|General Disorders and Administration Site Conditions||Infusion Site Paresthesia||1 (1.52%)||1 (0.28%)|
|Chest Discomfort||1 (1.52%)||1 (0.28%)|
|Skin and Subcutaneous Tissue Disorders||Generalized Pruritus||2 (3.03%)||2 (0.56%)|
|Vascular Disorder||Hot Flush||1 (1.52%)||1 (0.28%)|
|Hypertension||1 (1.52%)||2 (0.56%)|
|Nervous System Disorders||Dizziness||1 (1.52%)||1 (0.28%)|
|Dysgeusia||1 (1.52%)||1 (0.28%)|
|Tremor||1 (1.52%)||1 (0.28%)|
|Investigations||Heart Rate Increase||1 (1.52%)||1 (0.28%)|
|Electrocardiogram T Wave Inversions||1 (1.52%)||1 (0.28%)|
†This trial was done using a recombinant factor VIII.
Selected Important Risk Information
Side effects that have been reported with VONVENDI include nausea, tingling or burning at infusion site, chest discomfort, dizziness, hot flashes, itching, nausea, high blood pressure, muscle twitching, unusual taste, and increased heart rate.
Tell your healthcare provider about any side effects that bother you or do not go away.