Wilate

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Wilate Generic Name & Formulations

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

Mechanism of Action

Von Willebrand Factor/Factor VIII complex promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII leading to the formation of thrombin and fibrin.

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 VMD or 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. Routine prophylaxis (≥6yrs): 20–40 IU/kg two or three times per week. 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

Absorption

Cmax (VWD): 76.8 ± 1.3 IU/dL in children; (hemophilia A): 113.82 ± 20.53 IU/dL in adults; 83.92 ± 9.40 IU/dL in adolescents.

Distribution

Volume of distribution at steady state (VWD): 0.8 ± 1.5 dL/kg in children; (hemophilia A): 0.53 ± 0.13 dL/kg in adults; 0.73 ± 0.13 in adolescents.

Elimination

Clearance rate (VWD): 0.1 ± 1.5 dL/h/kg in children; (hemophilia A): 0.035 ± 0.013 dL/h/kg in adults; 0.051 ± 0.008 dL/h/kg in adolescents. Half-life (VWD): 8.3 ± 1.7 hours in children; (hemophilia A): 10.64 ± 2.69 hours in adults;11.41 ± 1.93 hours in adolescents.

Wilate Interactions

Not Applicable

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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