Coagulation Factor IX Concentrates (Pooled Human Plasma) Solution for injection

What is this medicine?

FACTOR IX (fak tir nine) is used in patients with hemophilia B to help control bleeding. Some products may also be used to control bleeding in patients with other disorders that prevent the blood from clotting properly.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease
• other coagulation problems
• thrombosis
• an unusual or allergic reaction to human or animal (mouse or hamster) protein, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Let the powder and solution warm to room temperature before use. Follow mixing directions carefully to avoid foaming. Swirl but do not shake the solution. Throw away any unused portion. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss doses. Ask your doctor or health care professional for instructions if you miss a dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• warfarin

This medicine may also interact with the following medications:

• aminocaproic acid
• tranexamic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Some factor IX products are derived from human plasma, and there is a small risk that they may contain certain types of virus or bacteria. All products are processed to kill most viruses and bacteria. If you have questions concerning the risk of viral infections, discuss them with your doctor or health care professional. If you are a newly diagnosed hemophiliac, you should have a hepatitis A and B vaccination.

If you are a hemophilia patient, carry an identification card with you at all times. The card should have your name, the name and dose of your medication(s), the name and phone number of your doctor or health care professional, and a contact person in case of emergency.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• chest pain, fast or irregular heartbeat (palpitations)
• difficulty breathing, wheezing
• fever or chills
• pain, redness or swelling at the injection site

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• flushing
• headache
• nausea, vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Follow individual manufacturer's storage guidelines. Throw away after expiration date. Once the solution has been prepared, use it within 3 hours.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.