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; contains polysorbate 80.
Shire US, Inc.
Indications for VONVENDI:
On-demand treatment and control of bleeding episodes in adults with von Willebrand disease (VWD). Perioperative management of bleeding in patients with VWD.
Max infusion rate: 4mL/min. ≥18yrs: Bleeding: give recombinant factor VIII (FVIII) with first infusion if baseline plasma FVIII level <40% or is unknown (see full labeling). Individualize; monitor and adjust according to extent and location of bleed. Minor: initially 40–50 IU/kg, then every 8–24hrs as needed. Major: initially 50–80 IU/kg, then 40–60 IU/kg every 8–24hrs for 2–3 days as needed. Surgery: see full labeling.
<18yrs: not established.
Hypersensitivity to hamster or mouse proteins.
Treatment should be supervised by physician. Risk of thromboembolic events in patients with known risk factors or an excessive rise in FVIII levels; monitor, give prophylaxis if clinically indicated. Discontinue immediately if severe allergic reactions occur. Monitor plasma VWF:RCo, FVIII, and inhibitors to VWF and/or FVIII (if suspected). Pregnancy. Nursing mothers.
Generalized pruritus, nausea, dizziness; thromboembolic events, antibody formation (consider alternatives).
Single-use vials—1 (w. diluent, supplies)