octapharma
For the treatment of VWD

wilate®: Efficacy

Clinical Efficacy in Adults and Pediatric Populations

Clinical efficacy of wilate® in patients with VWD was determined in four prospective clinical studies in 70 VWD adult patients. Among the 70 VWD adult patients, 45 received on-demand treatment for 1068 bleeding episodes. Using an additional set of objective efficacy criteria, 84% of the bleeding episodes were rated as being successfully treated. In these 45 patients, 93% of the successfully treated episodes were in patients with type 3 VWD (n=25). Among 11 pediatric patients (5-16 years of age), treated for 234 bleeding episodes, 88% were rated as being successfully treated, using objective criteria.1

Proven Efficacy for Surgery in All Types of VWD

Clinical efficacy of wilate® in perioperative patients was determined in a prospective, open-label, single-arm, uncontrolled, multi-center clinical study conducted to investigate the safety and hemostatic efficacy of wilate® in 28 adult and pediatric subjects who underwent 30 surgeries. The overall efficacy of wilate® treatment for surgical procedures in this study was 96.7%. Treatment with wilate® was successful in all minor surgeries and in 95.2% of major surgeries. It was also successful in all surgical procedures in VWD type 3 and type 2 subjects and in 85.7% of procedures in VWD type 1 subjects1*

*One failure was reported in a VWD type 1 subject undergoing lumbar laminectomy (major surgery) who experienced slightly greater blood loss (25 mL) than the expected maximum (20 mL).

3_Images_10

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

 

References

1. wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) full prescribing information. 2009.

Photos are of models and for illustrative purposes only.

Copyright © 2017. Octapharma USA Inc. All Rights Reserved.