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Vonvendi Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Clotting factor.
How Supplied
Single-use vials—1 (w. diluent, supplies)
Manufacturer
Generic Availability
NO
Vonvendi Indications
Indications
In adults 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 VWD receiving on-demand therapy.
Vonvendi Dosage and Administration
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. Perioperative management: see full labeling. Routine prophylaxis: initially 40–60 IU/kg twice weekly; adjust dose up to 60 IU/kg twice weekly if breakthrough bleeding occurs in joints or if severe bleeding occurs.
Children
<18yrs: not established.
Vonvendi Contraindications
Contraindications
Hypersensitivity to hamster or mouse proteins.
Vonvendi Boxed Warnings
Not Applicable
Vonvendi Warnings/Precautions
Warnings/Precautions
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.
Vonvendi Pharmacokinetics
See Literature
Vonvendi Interactions
Not Applicable
Vonvendi Adverse Reactions
Adverse Reactions
Headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, increased ALT, generalized pruritus; thromboembolic events, antibody formation (consider alternatives).
Vonvendi Clinical Trials
See Literature
Vonvendi Note
Not Applicable
Vonvendi Patient Counseling
See Literature
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