octapharma
For the treatment of VWD

wilate®: Viral Safety

Since human plasma can contain viruses, products made from plasma are treated to remove or destroy any viruses that might be present. Plasma products made today have an excellent safety record.1

Octapharma has high standards for its plasma collection centers. Collection centers, donors, and donated plasma are carefully selected and monitored. Octapharma requires all plasma donors to have a US social security number. Every plasma donor undergoes an extensive medical exam before being allowed to donate. All donated plasma undergoes individual unit testing for evidence of a wide variety of viruses (including HIV and hepatitis B and C). Any plasma found to contain these viruses is not used.

Double virus inactivation

  • Plasma used to make wilate® undergoes “double virus inactivation” to destroy any viruses that might remain after initial screening

 

1. Solvent/Detergent (S/D) process

The S/D process is the current gold standard for viral safety.2

  • The S/D process uses solvents and detergents to destroy the lipid membrane of viruses
  • Lipid-coated viruses, such as HIV, hepatitis B, hepatitis C and West Nile virus are quickly and permanently destroyed


Since the introduction of the S/D process, no infections with HIV, HBV, HCV, and WNV or other lipid-coated viruses have been associated with S/D treated products

2. PermaHeat process

PermaHeat is a heat inactivation process that adds one more level of safety on top of the S/D process.

  • During PermaHeat treatment, the wilate® product is heated to 100°C for 2 hours
  • The heat kills both lipid-coated and non-lipid-coated viruses, but does not affect the VWF
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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

References

1.  Canadian Hemophilia Society. An Introduction to von Willebrand disease. Last Update 2010. Available at: http://www.hemophilia.ca/en/bleeding-disorders/von-willebrand-disease/an-introduction-to-von-willebrand-disease/. Accessed April 9, 2010.
2.  Farrugia A. Guide for the assessment of clotting factor concentrates for the treatment of hemophilia. World Federation of Hemophilia. Available at: http://www.wfh.org/2/docs/Publications/Safety_and_Supply/ GuideClottingFactor_Eng.pdf. Accessed January 29, 2010.

 

 

Photos are of models and for illustrative purposes only.

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