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Efficacy & Safety

Learn about VONVENDI clinical study design

Study Design

Overview of the clinical study design

Get more information about the treatment outcomes for VWD with VONVENDI

Treatment Outcomes

Learn more about treatment outcomes with VONVENDI®

Learn about efficacy by bleed location

Efficacy by Location

Learn about VONVENDI hemostatic efficacy in a variety of bleeding episode locations

Get an overview of efficacy by bleed severity

Efficacy by Bleed Severity

Get an overview of hemostatic efficacy by bleeding episode severity

View the pharmacokinetic profile of VONVENDI as determined in two clinical trials

PK Data

The pharmacokinetic profile of VONVENDI was determined in two clinical trials

Learn about the safety findings

Safety Profile

Safety findings from the VONVENDI clinical trial

Please see Full Prescribing Information for perioperative management of bleeding.

VONVENDI MOA

See how VONVENDI supports hemostasis

VONVENDI Free Trial
Program

Eligible patients can try VONVENDI with 3 free doses

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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).

VONVENDI® [von Willebrand factor (recombinant)] Important Information

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 VWD patients treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after undergoing total hip replacement surgery.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, may occur. Symptoms can include anaphylactic shock, generalized urticaria, angioedema, chest tightness, hypotension, shock, lethargy, nausea, vomiting, paresthesia, pruritus, restlessness, wheezing and/or acute respiratory distress. Discontinue VONVENDI if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Neutralizing Antibodies (Inhibitors)

Inhibitors to von Willebrand factor 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 undergoing total hip replacement surgery.

Please see VONVENDI full Prescribing Information.