octapharma
For the treatment of VWD

wilate®: Pharmacokinetics

Parallel pharmacokinetic profiles of FVIII and VWF may help facilitate dosing and monitoring

Pharmacokinetic properties are an important consideration with multi-component therapeutic agents, such as VWF/FVIII concentrates. Each of the two components, VWF and FVIII, plays an important role in hemostasis. The physiologic 1:1 ratio in the concentrate, the similar recovery values, and the parallel decay curves for VWF and FVIII in wilate® may help facilitate dosing and monitoring.

Summary of pharmacokinetic results for VWF:RCo activity assay1

page5Chart

 

Parallel pharmacokinetic profiles for FVIII and VWF

Physiologic 1:1 ratio

Physiologic 1:1 ratio, similar recovery values, and the parallel decay curves for VWF
and FVIII in wilate® may help facilitate dosing and monitoring.

wilate® curves for VWF:RCo and FVIII:C
showed almost parallel decay over time1

page4PKchart

Mean plasma concentrations for VWF and FVIII with wilate® and Humate-P® in 6 patients with type 3 VWD
The clinical relevance of this data has not been established.

  • FVIII:C PK parameters1
    • Dose achieved for wilate® was twice that achieved with Humate-P®, likely due to the
      ~1:1 ratio with wilate compared to 1:0.4 with Humate-P®
    • wilate® showed parallel decay curves for VWF:RCo and FVIII:C over time
    • Humate-P® displayed a plateau for FVIII:C between 0 and 12-24 hours

 

Indications and Usage

wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding. wilate® is not indicated for the treatment of hemophilia A.

Important Safety Information

wilate® is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container.

Hypersensitivity or allergic reactions have been observed upon use of wilate® and may in some cases progress to severe anaphylaxis (including shock) with or without fever.

When using a factor VIII (FVIII)-containing von Willebrand Factor (VWF) product, the treating physician should be aware that continued treatment may cause excessive rise in FVIII activity. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thrombotic events.

Patients with VWD, especially type 3 patients, may potentially develop neutralizing antibodies (inhibitors) to VWF, manifesting as an inadequate clinical response. Since inhibitor antibodies may occur concomitantly with anaphylactic reactions, patients experiencing an anaphylactic reaction should also be evaluated for the presence of inhibitors.

wilate® is made from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, eg, viruses and, theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent or other unknown infectious agents, cannot be completely eliminated. Despite measures to reduce this risk, such products may still potentially transmit disease.

The most common adverse reactions to treatment with wilate® in patients with VWD have been urticaria and dizziness. The most serious adverse reactions to treatment with wilate® in patients with VWD have been hypersensitivity reactions.

Please see full prescribing information.

To report suspected adverse reactions, contact:
Octapharma USA Inc.
866-766-4860 or
FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

  1. Kessler CM, Friedman K, Schwartz BA, Gill JC, Powell JS, for the wilateR PK Study Investigators. The pharmacokinetic diversity of two von Willebrand factor (VWF)/factor VIII (FVIII) concentrates in subjects with congenital von Willebrand disease. Results from a prospective, randomised crossover study. Thromb Haemost. 2011;106:279-288.

Photos are of models and for illustrative purposes only.

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