Stay Updated
Menu

Efficacy by Location

The first and only rVWF to support effective hemostasis

Secondary efficacy measures were the number of treated bleeding episodes with an efficacy rating of “Excellent” or “Good,” the number of infusions and number of units of VONVENDI® [von Willebrand factor (Recombinant)], administered with or without recombinant factor VIII, per bleeding episode.1

In the clinical study, 100% of bleeds, despite severity, were resolved with an “Excellent” or “Good” rating.1

Efficacy by bleeding episode location in the clinical trial1
Chart depicting efficacy by bleeding episode location for VONVENDI in the clinical trial Chart depicting efficacy by bleeding episode location for VONVENDI in the clinical trial

Rating scale definitions1

Excellent

When the actual number of infusions needed to resolve a bleed was less than or equal to the estimated number of infusions required to treat the bleeding episode, regardless of severity.

Good

When resolution of minor and moderate bleeding episodes required 1-2 infusions greater than expected. Or, when resolution of major bleeding episodes was less than 1.5x infusions greater than the estimated number of infusions required to control the bleeding episode.

In all cases, no additional VWF coagulation factor-containing product was required.

96.9% of all bleeds had am "excellent " bleed resolution, while 3.1% of all bleeds had a "good" bleed resolution

Selected Important Risk Information

WARNINGS AND PRECAUTIONS

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. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VONVENDI and provide appropriate supportive care.

Administration

Learn how VONVENDI can be administered independently of rFVIII based on patient need

Efficacy by Bleed Severity

Get an overview of hemostatic efficacy by bleed severity

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).

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.