Wilate

What is Wilate?

• Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) used for the treatment of bleeding episodes.

VWF-GP1ba

Faktor-VIII

What are the uses of this medicine?

• Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) is used 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.

Limitations of use:

• 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 not indicated for Hemophilia A.

How does this medicine work?

• Patients suffering from von Willebrand disease (VWD) have a deficiency or abnormality of von Willebrand Factor (VWF).
• This reduction in VWF concentration in the bloodstream result in a correspondingly low FVIII activity and an abnormal platelet function thereby resulting in excessive bleeding.
• The VWF in Wilate is derived from normal human plasma and is expected to behave in the same way as endogenous VWF.
• Thus, administration of VWF allows correction of the hemostatic abnormalities in VWD patients at two levels:
• The VWF re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium and to the platelet membrane), providing primary hemostasis, as shown by the shortening of the bleeding time. This effect occurs immediately.
• The VWF induces correction of the associated FVIII deficiency in VWD. Administered intravenously, VWF binds endogenous FVIII (which is produced normally by the patient), and by stabilizing this factor, avoids its rapid degradation.
• This action is slightly delayed.
• However, administration of a FVIII-containing VWF preparation like Wilate rapidly restores the FVIII activity level to normal.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

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

What drug interactions can this medicine cause?

• No interactions with other medicinal products are known.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• The ratio between VWF: RCo and FVIII activities in Wilate is approximately 1:1.

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 through levels of >30%
Major	40-60 IU/kg	20-40 IU/kg every 12-24 hours	VWF:RCo and FVIII activity through levels of >50%

Administration:

• For Intravenous Use after Reconstitution
• Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a sterile, lyophilized powder for reconstitution for intravenous injection, provided in the following nominal strengths per vial:
• 500 IU VWF:RCo and 500 IU FVIII activities in 5 mL
• 1000 IU VWF:RCo and 1000 IU FVIII activities in 10 mL

This medicine is available in fallowing brand namesː

• Wilate

What side effects can this medication cause?

The most common side effects of this medicine include:

• urticaria and dizziness

What special precautions should I follow?

• Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed upon use of Wilate. If allergic symptoms occur, discontinue the administration immediately and contact the physician.
• When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an 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. In patients with antibodies against VWF, VWF is not effective and infusion of this protein may lead to severe adverse events. In all such cases, it is recommended that a center specialized in bleeding disorders be contacted.
• Wilate is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• No dose adjustment is needed for pediatric patients(5 to 16 years of age) as administered dosages were similar to those used in the adult population.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• ANTIHEMOPHILIC FACTOR HUMAN
• VON WILLEBRAND FACTOR HUMAN

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• Octapharma Pharmazeutika Produktionsges.m.b.H.
• Oberlaaer Strasse
• A-1100 Vienna, Austria

Distributed by:

• Octapharma USA Inc.
• 121 River Street, 12th floor
• Hoboken, NJ

What should I know about storage and disposal of this medication?

• Store Wilate for up to 36 months at +2°C to +8°C (36°F to 46°F) protected from light from the date of manufacture.
• Within this period, Wilate may be stored for a period of up to 6 months at room temperature (maximum of +25°C or 77°F).
• The starting date of room temperature storage should be clearly recorded on the product carton. Once stored at room temperature, the product must not be returned to the refrigerator.
• The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earliest. Do not freeze.
• Do not use after the expiration date.
• Store in the original container to protect from light.
• Reconstituted the Wilate powder only directly before injection. Use the solution immediately after reconstitution. Use the reconstituted solution on one occasion only, and discard any remaining solution.

• Dailymed label info on Wilate
• FDA Wilate

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