This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.

This medication should not be used to treat other types of factor deficiencies (such as factors II, VII, VIII, X) or factor problems (such as inhibitor to factor XIII), to reverse the effects of "blood thinners" (such as warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using factor IX 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 over several minutes as directed by your doctor. The dosage is based on your medical condition, age, weight, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse.

For some brands, it is important to limit the amount of blood entering the tubing and to avoid letting any blood enter the syringe. You may need to use a new vial of medication and new set of supplies if this occurs. Consult your pharmacist for details.

Tell your doctor if your condition lasts or gets worse.

Fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting may 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:

• swelling at injection site
• shortness of breath
• fast heartbeat
• signs of kidney problems (such as change in the amount of urine)
• swelling of the ankles/feet
• pain/redness/swelling of arms or legs
• new or increased bleeding/bruising

Get medical help right away if you have any very serious side effects, including:

• bluish fingers
• chest pain
• trouble breathing

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 factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or if you have any other allergies. This product may contain inactive ingredients (such as latex), 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, especially of:

• other clotting disorders (such as disseminated intravascular coagulation-DIC)
• recent surgery/procedure
• liver disease

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

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.

Some products that may interact with this drug include:

• drugs that help with clotting (such as aminocaproic acid, tranexamic acid)

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 and/or medical tests (such as factor IX activity) 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.

Consult the product instructions and your pharmacist for storage details. 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).