Generic Name and Formulations:
Von Willebrand Factor (recombinant); 650 IU VWF:RCo, 1300 IU VWF:RCo; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Shire US, Inc.
Indications for VONVENDI:
On-demand treatment and control of bleeding episodes in adults with von Willebrand disease (VWD).
Give recombinant factor VIII (FVIII) with first infusion if baseline plasma FVIII level <40% or is unknown (see full labeling). ≥18yrs: Minor bleed: initially 40–50 IU/kg, then every 8–24 hours as needed. Major bleed: initially 50–80 IU/kg, then 40–60 IU/kg every 8–24 hours for 2–3 days as needed. Monitor and adjust according to extent and location of bleed. Max infusion rate: 4mL/min.
<18yrs: not established.
Hypersensitivity to hamster or mouse proteins.
Treatment should be supervised by physician. Risk of thrombotic events in patients with known risk factors or an excessive rise in FVIII levels; monitor. Discontinue immediately if severe allergic reactions occur. Ineffectiveness may indicate antibody formation; monitor and consider alternative therapy. Pregnancy. Nursing mothers.
Generalized pruritus; antibody formation.
Single-use vials—1 (w. diluent, supplies)
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