Wilate Generic Name & Formulations
Legal Class
Rx
General Description
Von Willebrand Factor/Factor VIII Complex (human); 500 IU VWF:RCo and 500 IU FVIII activities per 5mL; 1000 IU VWF:RCo and 1000 IU FVIII activities per 10mL; pwd for IV injection after reconstitution; preservative-free; solvent-detergent treated.
Pharmacological Class
Coagulation factor complex.
How Supplied
Kit—1 (w. diluent, supplies)
Manufacturer
Wilate Indications
Indications
On-demand treatment and control of bleeding episodes in patients with von Willebrand disease (VWD) or hemophilia A. Perioperative management of bleeding in patients with VWD. Routine prophylaxis to reduce the frequency of bleeding episodes in patients with hemophilia A.
Wilate Dosage and Administration
Adults and Children
Give by IV injection at 2–4mL/min. VWD (<5yrs): contact manufacturer; (≥5yrs): Minor bleed: 20–40 IU/kg once, then 20–30 IU/kg every 12–24 hours as needed. Major bleed: 40–60 IU/kg once, then 20–40 IU/kg every 12–24 hours as needed. Surgery (give loading dose within 3hrs before); Minor: 30–60 IU/kg once, then 15–30 IU/kg (or half the loading dose) every 12–24 hours; Major: 40–60 IU/kg once, then 20–40 IU/kg (or half the loading dose) every 12–24 hours. Monitor and adjust according to VWF:RCo and FVIII activity, and location of bleed; usual treatment duration is 3 days (minor hemorrhage, minor surgery), 5–7 days (major hemorrhage), or ≥6 days (major surgery). Hemophilia A (<12yrs): contact manufacturer; (≥12yrs): Minor bleed: 30–40 IU/kg every 12–24 hours for ≥1 day. Moderate bleed: 30–40 IU/kg every 12–24 hours for ≥3–4 days. Major bleed: 35–50 IU/kg every 12–24 hours for ≥3–4 days. Life-threatening: 35–50 IU/kg every 8–24 hours until resolved. Routine prophylaxis: 20–40 IU/kg every 2–3 days. Monitor and adjust according to severity of deficiency/hemorrhage, desired FVIII level, presence of inhibitor. See full labeling.
Wilate Contraindications
Not Applicable
Wilate Boxed Warnings
Not Applicable
Wilate Warnings/Precautions
Warnings/Precautions
Treatment should be supervised by physician trained in coagulopathies. Risk of thrombotic events in VWD with sustained excessive FVIII levels; monitor. Ineffectiveness may indicate antibody formation (esp. for VWD type 3 patients); monitor; consider alternatives if confirmed. Risk of transmission of blood-borne diseases; consider vaccination against hepatitis A and B. Monitor pulse during injection; slow or stop infusion if marked increase in heart rate occurs. Pregnancy. Nursing mothers.
Wilate Pharmacokinetics
See Literature
Wilate Interactions
Wilate Adverse Reactions
Adverse Reactions
Urticaria, dizziness, pyrexia, hypersensitivity reactions (monitor); antibody formation.
Wilate Clinical Trials
See Literature
Wilate Note
Not Applicable
Wilate Patient Counseling
See Literature
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