VONVENDI [von Willebrand factor (recombinant)] is indicated for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding in adult patients with an option to be dosed independently of recombinant factor VIII (rFVIII), based on patient need as determined by monitoring levels.1

Give your appropriate adult patients the 1 and only recombinant von Willebrand factor (rVWF)

VONVENDI is a treatment that acts similarly to naturally occurring, functional VWF, allowing for binding to platelets and collagen and stabilization of endogenous FVIII.1

Not every person with VWD, every bleed, or every surgery requires VWF/FVIII complex.2

1

and only recombinant von Willebrand factor (rVWF).

Addresses the underlying cause of von Willebrand disease (VWD).1,3-7

1

factor allows for independent dosing.a

Enables healthcare providers to manage von Willebrand factor and factor VIII (FVIII) levels separately and specifically, based on patient need as determined by monitoring levels and clinical judgment.1

aVONVENDI contains only trace amounts of rFVIII.1

See Phase 3 Clinical Trial Results
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References: 1. VONVENDI [von Willebrand factor (recombinant)] Prescribing Information. 2. Favaloro EJ. Towards personalised therapy for von Willebrand disease: a future role for recombinant products. Blood Transfus. 2016;14(2):262-276. 3. Gill JC, Castaman G, Windyga J, et al. Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood. 2015;126(17):2038-2046. 4. Nichols WL, Hultin MB, James AH, et al. Von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA).Haemophilia. 2008;14(2):171-232. 5. Turecek PL, Mitterer A, Matthiessen HP. Development of a plasma- and albumin-free recombinant von Willebrand factor.Hämostaseologie. 2009;29(suppl 1):S32-S38. 6. The Lewin Group. Strategic Summit on Von Willebrand Disease. National Hemophilia Foundation. March 2015. 7. 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.

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

Detailed Important Risk Information
CONTRAINDICATIONS

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 80 subjects treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after total hip replacement surgery.

Hypersensitivity Reactions

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 anti-factor 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.

ADVERSE REACTIONS

In clinical trials, the most common adverse reactions observed in ≥2% of subjects (n=80) were generalized pruritus, vomiting, nausea, dizziness, and vertigo.

One subject treated with VONVENDI in perioperative setting developed deep vein thrombosis after total hip replacement surgery.

Please see VONVENDI full Prescribing Information.