octapharma
For the treatment of VWD

Manufacturing Process

wilate® is made from pooled human plasma. Plasma is a pale yellow liquid contained in blood. The different parts of the plasma are separated from each other; then the von Willebrand Factor (VWF) and Factor VIII (FVIII) are collected.

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 (Click here for more about Viral safety )

wilate® is made from large pools of human plasma collected in US, FDA-certified, plasma donation centers. Octapharma requires all plasma 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 high standards.

The manufacturing of wilate® involves many purification and virus inactivation steps.2,3

  • The plasma used for wilate® is screened for viruses such as HIV and hepatitis B and C. Any plasma found to contain these viruses is not used.
  • Plasma components are separated by size, ionic charge, and subject to multiple virus inactivation steps, and finally undergo an ultra-filtration step
  • Plasma used to make wilate® undergoes “double virus inactivation” to destroy any viruses that might remain after initial screening
    • Solvent/detergent (S/D) process (0.3% TnBP and 1% Octoxynol-9, Triton X-100) (Viral safety)
    • PermaHeat (100°C, 2h, terminal dry-heating (TDH)) (Viral safety)
  • Finally, wilate® is subjected to quality control and finally released for clinical use
 
 

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

3. Stadler M, Gruber G, Kannicht C, et al. Characterisation of a novel high-purity, double virus inactivated von Willebrand factor and factor VIII concentrate (Wilate®). Biologicals. 2006;34:1-8.

Photos are of models and for illustrative purposes only.

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