VONVENDI® [von Willebrand factor (Recombinant)]

Replace
only
what
your
patients
need

VONVENDI® 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 (rVIII), based on patient need as determined by monitoring levels.1

  • VONVENDI was designed precisely for von Willebrand disease.1
  • Surgical hemostatic efficacy in 100% of major, minor, and oral surgeries.1
  • On-demand bleed control in 100% of bleeds regardless of severity or location.1

Talk to a representative for more information about dosing independently of rFVIII.

Find a Rep

The first and only recombinant von Willebrand factor (rVWF)2

As the first rVWF, VONVENDI offers you the flexibility to independently manage VWF and FVIII according to each patient’s unique needs.1 See details in the Full Prescribing Information.

DOWNLOAD PRESCRIBING INFORMATION

FOR YOUR PATIENTS

Image of three dosing vials: Download the free trial program registration form for your eligible patients

Free Trial Program

Through Takeda’s FREEDOM OF CHOICE™ Free Trial Program, patients may be eligible to receive 3 free doses of VONVENDI.*

*Free Trial Program is for new VONVENDI patients only. Participants must receive consultation and approval from a healthcare provider.

Download Registration Form
Icon of the dollar symbol: Co-pay assistance for your eligible patients

CoPay Assistance

Financial assistance is available for eligible patients through Takeda’s CoPay Assistance Program.

Enroll Now
Thumbnail of a shield: Visit the Hematology Support Center website for healthcare professionals

HEMATOLOGY SUPPORT CENTER

Providers and their staff can get assistance with reimbursement, access, and other issues through a full-service hotline.

Go to HSC

References: 1. VONVENDI [von Willebrand factor (Recombinant)] Prescribing information. Lexington, MA: Baxalta US Inc; 2019. 2. Baxalta receives FDA Approval for VONVENDI, the first and only recombinant treatment for adults affected by von Willebrand disease. Business Wire website. https://www.businesswire.com/news/home/20151208006689/en/Baxalta-Receives-FDA-Approval-VONVENDI-Recombinant-Treatment. Published December 8, 2015. Accessed March 8, 2019.

See LessMore

Indications VONVENDI [von Willebrand factor (recombinant)] is a recombinant von…

Detailed Important Risk Information Do not use VONVENDI in patients who have had life-threatening hypersensitivity reactions…

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 VONVENDI 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).

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 VONVENDI 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.