Wilate is an injection containing antihemophilic and von Willebrand factors. Antihemophilic and von Willebrand factors are naturally occurring proteins in the blood that help the blood to clot.

A lack of antihemophilic factor VIII is the cause of hemophilia A. A lack of von Willebrand factor is the cause of von Willebrand disease. This medicine works by temporarily raising levels of factor VIII or von Willebrand factor in the blood to aid in clotting.

Wilate is used to treat bleeding episodes in people with von Willebrand disease.

You should not use Wilate if you have ever had a severe allergic reaction to antihemophilic factor in the past.

Carefully follow all instructions about how to store this medicine. Each brand of antihemophilic and von Willebrand factor complex may have specific storage instructions.

Before using this medicine

You should not use Wilate if you have ever had a severe allergic reaction to antihemophilic factor.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.

Your doctor may want you to receive a hepatitis vaccination before you start using Wilate.

It is not known whether Wilate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether antihemophilic and von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Wilate is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Use Wilate exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Wilate is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Wilate is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing the medicine with a diluent, store at room temperature and use it within 3 hours. Do not refrigerate or freeze.

Do not use Wilate if it has changed colors or has particles in it. Call your pharmacist for new medicine.

While using this medicine, you may need frequent blood tests.

• 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 Wilate 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.

If stored in a refrigerator, take the vials out of the refrigerator and allow them to reach room temperature before preparing your dose.

Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

You should not use Wilate if you have ever had a severe allergic reaction to antihemophilic factor.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.

Your doctor may want you to receive a hepatitis vaccination before you start using Wilate.

It is not known whether Wilate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether antihemophilic and von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Wilate is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Since Wilate is used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Wilate: hives; chest tightness, wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• hot flashes when the injection is given;

• sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• sudden cough, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• bleeding from a wound or where the medicine was injected; or

• bleeding that is not controlled.

Common Wilate side effects may include:

• nosebleeds;

• rash or itching;

• numbness or tingling;

• headache, dizziness; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.