VONVENDI

Bleeding disorders:

Indications for: VONVENDI

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.

Adult Dosage:

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 Dosage:

<18yrs: not established.

VONVENDI Contraindications:

Hypersensitivity to hamster or mouse proteins.

VONVENDI 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 Classification:

Clotting factor.

Adverse Reactions:

Headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, increased ALT, generalized pruritus; thromboembolic events, antibody formation (consider alternatives).

Generic Drug Availability:

NO

How Supplied:

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