octapharma
For the treatment of VWD

Octapharma: Stringent plasma requirements

The safety and quality of plasma products begin with the starting material. wilate® is derived exclusively from large pools of human plasma collected in US FDA-certified plasma donation centers.

Plasma collection centers, donors, and donated plasma are carefully selected and monitored. Octapharma requires all donors to have a US social security number. Every plasma collection center is thoroughly inspected by Octapharma’s Quality Assurance auditors and must meet our demanding high standards prior to acceptance. Following initial approval, all plasma centers undergo regular ongoing inspections by both Octapharma and the relevant national authorities.

Every donor undergoes extensive medical examination prior to becoming eligible to donate. All donated plasma undergoes individual unit testing for antibodies against HIV-1/2, HBV, and HCV. In addition, the plasma undergoes PCR (NAT) testing for HIV, HBV, HCV, HAV, and parvovirus B19.

Octapharma has a history of setting the benchmark for product and patient safety by utilizing multiple validated viral inactivation and removal procedures, including solvent/detergent, Pasteurization, Terminal Dry Heat Treatment, and Nanofiltration. As with all plasma-derived products, the risk of transmission of infectious agents cannot be completely eliminated. All product batches undergo rigorous quality control and internal batch release evaluation. In addition, batch release is performed by national and international regulatory agencies, including the FDA.

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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

 

 

Photos are of models and for illustrative purposes only.

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