Antihemophilic Factor VIII Human (an-tee-hee-moe-FIL-ik FAK-tor ATE HUE-man), Von Willebrand Factor Human (Von WILL-a-brand FAK-tor HUE-man)

Controls and prevents bleeding in hemophilia A and von Willebrand disease. Also used to prevent bleeding during surgery.

Brand Name(s):

Alphanate, Humate-P, Wilate

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Swirl the Wilate® vial gently to dissolve the powder. Do not shake. Do not use the mixed liquid if it is cloudy, discolored, or has particles in it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• You may store the Wilate® unopened vial in the refrigerator for up to 36 months. Do not freeze. You may also store it at room temperature for up to 6 months. Do not place it back in the refrigerator once stored at room temperature. Use the medicine right away after mixing it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, you received a hepatitis A or hepatitis B vaccine shot, or you ever had a blood clot.
• This medicine may increase your risk for blood clots, especially if you have a history of clots.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Call your doctor right away if you continue to have bleeding problems even after you use this medicine. Also call if your medicine does not seem to be working as well as usual.
• This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. Although the risk is low, talk with your doctor if you have concerns.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood, or troubled breathing
• Fever or chills, headache
• Lightheadedness, dizziness, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with speech, vision, or walking
• Pain or weakness in your calf
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding or bruising
• Warmth or redness in your face, neck, arms, or upper chest
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Joint or muscle pain
• Nausea, vomiting, or loss of appetite
• Pain, itching, burning, stinging, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088