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On-Demand Dosing

Dose according to your patient's individual needs


For Surgical Dosing Information, please see Full Prescribing Information

On-Demand Dosing Information1
Chart depicting the on-demand dosing information for VONVENDI Chart depicting the on-demand dosing information for VONVENDI

 

*If recombinant factor VIII (rFVIII) is administered, see rFVIII package insert for reconstitution and administration instructions.

A bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (e.g., intracranial or gastrointestinal hemorrhage).

Selected Important Risk Information

WARNINGS AND PRECAUTIONS

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.

Consider these factors when determining your patient's dose

  • Bleed severity types

    Bleed severity

    Minor1 (e.g., readily managed epistaxis, oral bleeding, menorrhagia)

    Major1* (e.g., severe or refractory epistaxis, menorrhagia, GI bleeding, CNS trauma, hemarthrosis, or traumatic hemorrhage)

    *A bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (e.g., intracranial or gastrointestinal hemorrhage).

  • Factor VIII

    FVIII levels

    If plasma FVIII:C level is <40% or unknown administer an approved (non–von Willebrand factor–containing) rFVIII with the first infusion.1

    If an immediate rise in FVIII:C is not necessary, or if the baseline FVIII:C level is sufficient to ensure hemostasis, VONVENDI [von Willebrand factor (Recombinant)] can be administered without rFVIII.1

Comprehensive dosing information can be found in the VONVENDI full Prescribing Information.

Example Dosing

A patient weighing 70 kg experiencing a major bleed and requiring 80 IU/kg of VONVENDI will be infused 5600 IU of VONVENDI and 4308 IU of rFVIII for the initial bleeding episode. If required, subsequent dose is 4200 IU of VONVENDI based on 60 IU/kg infused every 8 to 24 hours for approximately 2 to 3 days (as clinically required).

VONVENDI dose [IU] = dose in [IU/kg] x weight [kg]

Recombinant FVIII dose [IU] = VONVENDI dose divided by 1.3

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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.