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Brand Names: Alphanine SD, Benefix, Mononine

Generic Name: coagulation factor IX (Pronunciation: koh AG yoo LAY shun FAK tor)

• What is coagulation factor IX (Benefix)?
• What are the possible side effects of coagulation factor IX (Benefix)?
• What is the most important information I should know about coagulation factor IX (Benefix)?
• What should I discuss with my healthcare provider before using coagulation factor IX (Benefix)?
• How should I use coagulation factor IX (Benefix)?
• What happens if I miss a dose (Benefix)?
• What happens if I overdose (Benefix)?
• What should I avoid while using coagulation factor IX (Benefix)?
• What other drugs will affect coagulation factor IX (Benefix)?
• Where can I get more information?

What is coagulation factor IX (Benefix)?

Coagulation factor IX is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency.

Coagulation factor IX may also be used for purposes other than those listed here.

What are the possible side effects of coagulation factor IX (Benefix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fever or chills;
• continued bleeding after treatment;
• feeling like you might pass out;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance; or
• swelling in your feet or ankles, weight gain, loss of appetite.

Less serious side effects may be more likely to occur, such as:

• headache;
• warmth, redness, or tingly feeling under your skin;
• nausea, vomiting;
• dizziness; or
• pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about coagulation factor IX (Benefix)?

Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or heart attack.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.