Coagulation Factor IX Concentrates Solution for injection

FACTOR IX COMPLEX (FAK ter nyne KUM pleks) is used in patients with hemophilia B to help control bleeding.

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

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

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.

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
• changes in vision
• confusion, trouble speaking or understanding
• cough or other signs of infection
• fever or chills
• severe headaches
• shortness of breath, chest pain, swelling in a leg
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination

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

• headache
• nausea, vomiting

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.

This drug is given in a hospital or clinic and will not be stored at home.

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

• heart disease
• history of blood clots
• history of heparin-induced thrombocytopenia
• liver disease
• an unusual or allergic reaction to factor IX complex, heparin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

This medicine may interact with the following medications:

• aminocaproic acid
• factor VIIa
• 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.

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

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 an emergency.