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VONVENDI
Bleeding disorders
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Drug Name:

VONVENDI Rx

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.

Company:
Shire US, Inc.

Therapeutic Use:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

Hypersensitivity to hamster or mouse proteins.

Warnings/Precautions:

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Generalized pruritus, nausea, dizziness; thromboembolic events, antibody formation (consider alternatives).

Generic Availability:

NO

How Supplied:

Single-use vials—1 (w. diluent, supplies)

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