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Explore safety across pivotal studies¹

Indications

VONVENDI [von Willebrand factor (recombinant)] is indicated in adult and pediatric patients with von Willebrand disease (VWD) for¹:

• On-demand treatment and control of bleeding episodes.
• Perioperative management of bleeding.

For adult patients only:

• Routine prophylaxis to reduce the frequency of bleeding episodes.

VONVENDI: an established safety profile¹

• VONVENDI's safety profile was established in 6 clinical trials¹
• VONVENDI is the first and only recombinant VWF treatment option for VWD^1-5
• Recombinant products are manufactured without blood or human plasma, so there is virtually no risk of blood-borne pathogen transmission^6,7

Of the 132 total study participants across 6 clinical studies, the following adverse reactions were observed: headache (n=18), vomiting (n=9), nausea (n=7), dizziness (n=4), generalized pruritus (n=3), hypertension (n=2), vertigo (n=2), tachycardia (n=1), infusion site paresthesia (n=1), chest discomfort and increased heart rate (n=1), hot flush (n=1), deep vein thrombosis (n=1), dysgeusia (n=1), tremor (n=1), electrocardiogram T wave inversions (n=1)^1,8

Across all studies and age groups, no study participants developed anaphylaxis or neutralizing antibodies.^1,8

Pooled safety data from six clinical studies¹

*One patient developed infusion-related reaction experiencing chest discomfort and increased heart rate.¹

References

1. VONVENDI [von Willebrand factor (Recombinant)] Prescribing Information.
2. HUMATE-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] Prescribing Information. CSL Behring GmbH; 2020.
3. WILATE Full Prescribing Information. Paramus, NJ: Octapharma; rev December 2023.
4. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.
5. FDA Approves Prophylactic Treatment with VONVENDI [von Willebrand Factor (Recombinant)] for Adult Patients Living with Severe Type 3 von Willebrand Disease (VWD). Businesswire. Accessed August 14, 2025. https://www.businesswire.com/news/home/20220131005214/en/FDA-Approves-Prophylactic-Treatment-with-VONVENDI-von-Willebrand-Factor-Recombinant-for-Adult-Patients-Living-with-Severe-Type-3-von-Willebrand-Disease-VWD
6. Franchini M, Mannucci PM. Von Willebrand factor (Vonvendi®): the first recombinant product licensed for the treatment of von Willebrand disease. Expert Rev Hematol. 2016;9(9):825-830.
7. Turecek PL, Mitterer A, Matthiessen HP, et al. Development of a plasma- and albumin-free recombinant von Willebrand factor. Hamostaseologie. 2009;29 Suppl 1:S32-S38.
8. Data on file, Takeda, Inc.