Vonvendi

Product Specs Description
Manufacturer Name Takeda
Indications

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
  • Routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.
Contraindications Do not use in patients who have had life-threatening hypersensitivity reactions to VONVENDI or its components (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80 and hamster or mouse proteins)
Source Plasma Purified rVWF expressed in Chinese Hamster Ovary (CHO) cells. VONVENDI is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture,purification,or formulation of the final product
Viral Safety Process Immunoaffinity chromatography
Product Half-Life 19.1 (4.91) hours
Product Recovery Percentage 1.9%
Storage Requirements/Shelf Life
  • Refrigerate at 2°C to 8°C (36°F to 46°F) or at room temperature up to 30°C (86°F).
  • Do not return to refrigerated temperature after storing at room temperature.
  • Do not freeze.
  • Store in original packaging to protect from light.
  • Do not use beyond the expiration date printed on the label.
  • Do not use if the solution in the syringe is cloudy or contains flakes or particles after filtration from the vial into the syringe.
  • Use reconstituted product immediately or within 3 hours after reconstitution.
Nominal Vial Size & Diluent Volume 450-850 IU/5 mL
900-1700 IU/10 mL


MANUFACTURER NAME LISTING


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