octapharma
For the treatment of VWD

wilate®: Special Populations

Pregnancy/nursing

wilate® has been designated Pregnancy Category C. Animal reproduction studies have not been conducted with wilate®. It is also not known whether wilate® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. wilate® should be given to a pregnant woman only if clearly needed. wilate® has not been studied in labor or delivery or in lactating women. It should be administered to VWF-deficient women at labor or delivery only if clearly indicated.1

Pediatric use

Eleven pediatric patients with VWD between 5 to 16 years of age (8 type 3, 1 type 2, 2 type 1) were treated with wilate® for 234 bleeding episodes in clinical studies. These studies showed that 88% of the bleeding episodes were treated successfully in this population. No dose adjustment is needed for pediatric patients as administered dosages were similar to those used in the adult population.1

Geriatric use

Although some of the patients who participated in the wilate® studies were over 65 years of age, the number of patients was inadequate to allow subgroup analysis to support recommendations in the geriatric population.1
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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

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

Photos are of models and for illustrative purposes only.

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