This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. Factors are proteins normally found in the blood that help the blood to thicken (clot) and stop any bleeding. People with low levels of factor VIII and von Willebrand factor are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product is used to temporarily replace the missing factors and reduce bleeding.

Different brands of this product have different amounts of these factors, and so have different uses. These products are not interchangeable. Do not change brands of this medication without the approval of your doctor. Some products are used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Some products are used to control and prevent bleeding episodes in people with low levels of von Willebrand factor (von Willebrand disease). Some products are used to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.

This medication is given by slow injection into a vein as directed by your doctor. How fast you receive this medication depends on your dose and how you respond to it. See Side Effects section.

This medication is given in a hemophilia treatment center or hospital. In some cases, patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the product information available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. If you have any questions, ask your health care professional.

If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the vial to completely dissolve the powder. Do not shake the vial. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. After the medication is mixed, use right away.

The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely. Ask your doctor or pharmacist if you have any questions.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Tell your doctor if your condition does not get better or if it gets worse.

Flushing of the face, nausea, vomiting, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and numbness/tingling of the hands/feet may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of anemia (such as tiredness, low energy, pale skin color, shortness of breath)
• new or worsening bleeding/bruising

This medication may rarely cause serious blood clots. Get medical help right away if you notice any of the following very serious side effects:

• pain/swelling/warmth in the groin/calf
• chest/jaw/left arm pain
• sudden vision changes
• confusion
• trouble speaking
• weakness on one side of the body
• sudden/severe headaches
• sudden dizziness/fainting
• shortness of breath/rapid breathing
• unusual sweating

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to any clotting factor products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some factor VIII products recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab tests (such as factor VIII levels, von Willebrand factor levels, clotting tests) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to follow the dosing schedule as directed by your doctor. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).