Wilate

Wilate

Generic Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Date of Approval: December 4, 2009

Company: Octapharma USA

Treatment for: von Willebrand's Disease

FDA Approves Wilate

The U.S. Food and Drug Administration has approved Wilate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD).

Highlights of Prescribing Information

These highlights do not include all the information needed to use Wilate safely and effectively. See full prescribing information for Wilate.

Wilate Indications and Usage

Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

Wilate is not indicated for the prophylaxis of spontaneous bleeding episodes, or the prevention of excessive bleeding during and after surgery in VWD patients.

Wilate is also not indicated for Hemophilia A

Dosage and Administration

For Intravenous Use Only

Type of Hemorrhages

Loading Dosage (IU VWF:RCo /kg BW)

Maintenance Dosage (IU VWF:RCo /kg BW)

Therapeutic Goal

Minor

20-40 IU/kg

20-30 IU/kg every 12-24 hours

VWF:RCo and FVIII activity trough levels of >30%

Major

40-60 IU/kg

20-40 IU/kg every 12-24 hours

VWF:RCo and FVIII activity trough levels of >50%

Dosage Forms and Strengths

Wilate is a sterile, lyophilized powder for reconstitution for intravenous injection, provided in the following nominal strengths per vial:

450 IU VWF:RCo and 450 IU FVIII activities in 5 mL

900 IU VWF:RCo and 900 IU FVIII activities in 10 mL

Contraindications

Hypersensitivity with known anaphylactic or severe systemic reaction to human plasma-derived products, any ingredient in the formulation, or components of the container.

Warnings and Precautions

Hypersensitivity reaction

Thromboembolic events associated with von Willebrand factor/Coagulation Factor FVIII (VWF/FVIII) products: plasma levels of FVIII activity should be monitored to avoid sustained excessive FVIII levels, which may increase the risk of thrombotic events

Potential for inducing antibodies to Factor VIII (inhibitors) and antibodies to VWF, especially in VWD type 3 patients

Theoretical risk of infectious agents transmission as the product is made from human plasma

Wilate Side Effects

The most common adverse reactions in clinical studies on VWD were urticaria and dizziness (each 2.2%).

To report SUSPECTED ADVERSE REACTIONS, contact Octapharma USA Inc. at phone # 866-766-4860 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See also: Wilate side effects (in more detail)

Drug Interactions

None known.

Use In Specific Populations

Pregnancy: No human or animal data. Use only if clearly needed.

Patient Counseling Information for Wilate

Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If allergic symptoms occur, patients should discontinue the administration immediately and contact their physician.

Inform patients that undergoing multiple treatments with Wilate may increase the risk of thrombotic events thereby requiring frequent monitoring of plasma VWF:RCo and FVIII activities.

Inform patients that there is a potential of developing inhibitors to VWF, leading to an inadequate clinical response. Thus, if the expected VWF activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, contact the treating physician.

Inform patients that despite procedures for screening donors and plasma as well as those for inactivation or removal of infectious agents, the possibility of transmitting infective agents with plasma-derived products cannot be totally excluded.