This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A.

This medication should not be used to treat von Willebrand disease.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor. The injection time may be different, depending on your dose and how you respond to it.

After first receiving this medication in a clinic or hospital, some people may be able to give this medication to themselves at home. If your doctor directs you to use this medication at home, read the Instructions for Use and learn all preparation and usage instructions from your health care professional. Learn how to store and discard medical supplies safely. If you have any questions, ask your health care professional.

If the medication and the solution used to mix it are refrigerated, take them out of the refrigerator ahead of time and let them come to room temperature before mixing. After mixing, gently swirl to completely dissolve the powder. Do not shake. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Use the mixed medication as soon as possible, but no later than 3 hours after mixing. Do not refrigerate the mixed medication.

The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions carefully.

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

Headache or joint pain may occur. If either of these effects lasts or gets 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.

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
• chest discomfort/tightness

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 antihemophilic factor (factor VIII) 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The manufacturers of some brands of this medication recommend that you check your pulse while giving yourself the injection. If your heart starts to beat faster, you may need to give this medication more slowly or stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

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

It is unknown if this medication 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 blood tests (such as factor VIII levels, factor VIII inhibitors) 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 get each dose of this medication as scheduled. 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.

Store in the refrigerator. Do not freeze. Keep the medication in the original package to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 6 months. After mixing, use this medication within 3 hours. Discard any unused portion. 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).