Preparing, reconstituting, and administering VONVENDI® [von Willebrand factor (Recombinant)]

VONVENDI is available as a non-pyrogenic lyophilized powder for reconstitution in single-use vials containing nominally 650 or 1300 international units VWF:RCo per vial.1

product strengths OF VONVENDI single-use vials
Color Code
Green
Dark Red
VWF:RCo Potency Range
450–850 IU per vial
900–1700 IU per vial
Carton NDC
0944-7551-02
0944-7553-02
sWFI fill size
5 mL
10 mL
  • Each package includes VONVENDI, Sterile Water for Injection (sWFI), one MIX2VIAL® reconstitution device, one full prescribing physician insert, one patient insert, and one instructions for use1
  • The actual product strength will be printed on the vial label and on the box1

Preparation and Reconstitution1

  • Allow VONVENDI and sterile Water for Injection (diluent) to reach room temperature if it has been refrigerated
  • If the patient requires more than one vial of VONVENDI per injection, reconstitute each vial separately according to the following instructions

Reconstitution and Administration guidelines1

  • Administer VONVENDI immediately after reconstitution. If not, store at room temperature not to exceed 25°C (77°F) for up to 3 hours. Discard after 3 hours
  • If a patient is to receive more than one vial of VONVENDI, the contents of up to two vials may be pooled into a single syringe. Pooling of more than two vials into a syringe may result in formation of filaments, which requires discarding of the solution in the syringe. Leave syringe attached to the vial or cover syringe tip with a suitable sterile cap until ready to infuse to reduce risk of contamination
  • Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes
  • Do not mix VONVENDI with other medicinal products

Reconstitution and Administration1

Please see the VONVENDI full Prescribing Information for the eight complete steps required to reconstitute VONVENDI and the nine complete steps required to administer VONVENDI.1

VONVENDI may be stored at room temperature (≤30°C/86°F) for the life of the product1

Store at room temperature not to exceed 30°C (86°F) or at refrigerated temperature 2°C to 8°C (36°F to 46°F)

  • Do not freeze
  • Store in the original box and protect from extreme exposure to light
  • Do not use beyond the expiration date printed on the VONVENDI vial label or carton
  • Use reconstituted product immediately or within 3 hours after reconstitution
  • Discard any unused reconstituted product after 3 hours
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Reference: 1. VONVENDI [von Willebrand factor (recombinant)] Prescribing 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 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.