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Factor IX (Recombinant) Complex

Generic Name: Factor IX (Recombinant) Complex (FAK-tuhr nine)
Brand Name: Examples include AlphaNine SD and Proplex T

Because Factor IX (Recombinant) Complex is made from human blood, it is possible you may develop infections from it (eg, hepatitis, viral infections). Notify your doctor immediately if you develop any signs of an infection or hepatitis (eg, fever, persistent sore throat, unusual fatigue, yellowing eyes or skin, dark urine). You may develop blood clots with the use of Factor IX (Recombinant) Complex . Notify your doctor if you develop arm or leg pain/swelling, trouble breathing, or chest pain.

Factor IX (Recombinant) Complex is used for:

Controlling and preventing bleeding episodes in patients with hemophilia B.

Factor IX (Recombinant) Complex is a clotting factor. It works by correcting defects in patients who have deficiencies of certain clotting factors.

Do NOT use Factor IX (Recombinant) Complex if:

you are allergic to any ingredient in Factor IX (Recombinant) Complex
you are allergic to hamster protein
you have severe blood clotting problems (eg, fibrinolysis, disseminated intravascular coagulation)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Factor IX (Recombinant) Complex :

Some medical conditions may interact with Factor IX (Recombinant) Complex . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver disease, have a bleeding disorder, are at risk for blood clots, or have recently undergone surgery

Some MEDICINES MAY INTERACT with Factor IX (Recombinant) Complex . However, no specific interactions with Factor IX (Recombinant) Complex are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Factor IX (Recombinant) Complex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Factor IX (Recombinant) Complex :

Use Factor IX (Recombinant) Complex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Factor IX (Recombinant) Complex is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Factor IX (Recombinant) Complex at home, carefully follow the injection procedures taught to you by your health care provider.
Always wash your hands and carefully follow procedures for preparing and giving yourself Factor IX (Recombinant) Complex .
To use Factor IX (Recombinant) Complex , warm both vials to room temperature.
Do not shake vial after adding diluent.
Factor IX (Recombinant) Complex will be given through a vein after it is mixed with sterile water for injection.
Use Factor IX (Recombinant) Complex within 3 hours after the solution is mixed. Do not use leftover medicine or use Factor IX (Recombinant) Complex beyond the expiration date on the container.
If Factor IX (Recombinant) Complex contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Factor IX (Recombinant) Complex , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Factor IX (Recombinant) Complex .

Important safety information:

Additional monitoring of your dose or condition may be needed if you are taking drugs that aid blood clotting (eg, tranexamic acid, aminocaproic acid) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen).
LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Factor IX (Recombinant) Complex with extreme caution in NEWBORNS. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Factor IX (Recombinant) Complex , discuss with your doctor the benefits and risks of using Factor IX (Recombinant) Complex during pregnancy. It is unknown if Factor IX (Recombinant) Complex is excreted in breast milk. If you are or will be breast-feeding while you are using Factor IX (Recombinant) Complex , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Factor IX (Recombinant) Complex :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; flushing; headache; nausea; stinging at the injection site; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); arm or leg pain/swelling; chest pain; dark urine; fever; persistent sore throat; unusual fatigue; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately.

Proper storage of Factor IX (Recombinant) Complex :

Store Factor IX (Recombinant) Complex in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). It may also be stored at room temperature, not to exceed 77 degrees F (25 degrees C), for up to 6 months. Do not freeze. Do not store in the bathroom. Keep Factor IX (Recombinant) Complex out of the reach of children and away from pets.

General information:

If you have any questions about Factor IX (Recombinant) Complex , please talk with your doctor, pharmacist, or other health care provider.
Factor IX (Recombinant) Complex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Factor IX (Recombinant) Complex . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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