factor VIII

What it is used for

WILATE is an injectable medicine that is used to treat and control bleeding in children and adults with VWD. It is also used for routine prophylaxis to reduce the number of bleeding episodes as well as for perioperative management of bleeding. WILATE is used to treat and control bleeding in adolescents and adults with hemophilia A. It is also used for routine prophylaxis to reduce the number of bleeding episodes.

Allergic reactions may occur. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives.

Because it is made from human blood, there is the risk that WILATE can potentially transmit disease or cause allergic reactions. Tell your healthcare provider if you have low-grade fever, rash, joint pain, nausea, vomiting, feeling tired, and yellowing of the skin.

Common side effects of WILATE in VWD are hypersensitivity reactions, urticaria, chest discomfort, and dizziness.

A common side effect of WILATE in hemophilia A is fever.

Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of WILATE.

These are not all of the possible side effects from WILATE. Ask your healthcare provider for more information. You are encouraged to report side effects to Octapharma USA Inc. at 1-866-766-4860 or FDA at 1-800-FDA-1088.

Talk to your healthcare provider about any side-effect that bothers you or that does not go away.

How to take it

You get WILATE as an infusion into your vein after reconstitution of the lyophilized powder by mixing it with the supplied 5 or 10 milliliter sterile solvent (Water for Injection with 0.1% Polysorbate) with the supplied transfer device (see instruction for reconstitution and injection of WILATE).

Your healthcare provider will instruct you on how to do reconstitutions and infusions using sterile technique on your own or with the help of a family member, and they may watch you give yourself the first dose of WILATE.

You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing WILATE so that your treatment will work the best that it can for you.

WILATE comes in different dosage strengths. The actual number of international units (IU) of von Willebrand Factor and Factor VIII in the vial will be imprinted on the label and box. Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.

Contact your healthcare provider right away if bleeding is not controlled after using WILATE.

Talk to your healthcare provider before travelling. Plan to bring enough WILATE for your treatment during this time.

If you forget to use WILATE, do not inject a double dose to make up for the forgotten dose. Proceed with the next infusion as scheduled.

Do not stop using WILATE without consulting with your healthcare provider.

Who should not take it

You should not use WILATE if you are allergic to von Willebrand Factor or Factor VIII or any of the other ingredients of WILATE.

What to say before you start

Talk to your healthcare provider about any medical conditions that you have or have had.

Tell your healthcare provider about all of the prescription and non-prescription medicines you take, including over-the-counter medicines, dietary supplements, or herbal medicines.

Tell your healthcare provider if you are pregnant or nursing because WILATE might not be right for you.

Storing it

Keep WILATE in its original box to protect it from exposure to light. Do not freeze WILATE.

You can store WILATE for up to 36 months at +2°C to +8°C (36°F to 46°F) from 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). Note on the carton the date which the product was removed from the refrigerator.

After storage at room temperature, the product must be used or discarded, and it must not be put back into the refrigerator.

Do not use WILATE after the expiration date printed on the vial.

Do not use WILATE if the reconstituted solution is cloudy, contains particles, or is not colorless.

WILATE within 4 hours after mixing.

Dispose all materials, including any unused WILATE, in an appropriate container.

What else should I know about WILATE ?

Do not use WILATE for a medical condition for which it was not prescribed. Do not share WILATE with other people, even if they have the same diagnosis and symptoms that you have.

Resources at Octapharma available to patients

For more product information on WILATE, please visit www.wilateusa.com

For more information on patient assistance programs that are available to you, please contact the Octapharma Patient Support Center at 1-800-554-4440.

Manufactured by

Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Strasse 235, A-1100 Vienna, Austria

U.S. License No. 1646

Distributed by

Octapharma USA, Inc., 117 West Century Road, Paramus, NJ 07652

wilate® is a registered trademark of Octapharma.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: July 2026