Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate® full Prescribing Information.
Indication
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in adult and pediatric patients with von Willebrand disease for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes. wilate® is also indicated in adult and pediatric patients 12 years of age and older with hemophilia A for on-demand treatment and control of bleeding episodes; and for routine prophylaxis to reduce the frequency of bleeding episodes.
Contraindications
Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
- Anaphylaxis and severe hypersensitivity reactions are possible
- Thromboembolic events may occur. Monitor plasma levels of FVIII activity
- Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of wilate®. Test for neutralizing antibodies if plasma VWF and/or Factor VIII level fail to increase as expected or if bleeding is not controlled after wilate® administration
- wilate® is made from human plasma and carries the risk of transmitting infectious agents
Adverse Reactions
The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness. The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).
Please see wilate® full Prescribing Information.