Factor IX Complex

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 therefore 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 reverse the effects of "blood thinners" (e.g., warfarin). Most types of this medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII). If you are using this medication for one of these conditions, consult your doctor or pharmacist to make sure that you are using the right product.

If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

This medication is given by injection into a vein by a health care professional. Learn all preparation and usage instructions for this product. Before using this product, check it visually for particles or discoloration. Do not use the liquid if it is discolored. Gently swirl the medication to mix. Do not shake. Some forms of this medication must be completely mixed into the liquid so that the liquid contains no particles. In these cases, do not use the liquid if it contains particles. Other forms of this medication may occasionally contain a few small particles in the vial, even if the medication is mixed correctly. In these cases, the particles will not affect how well the medication works and will be removed by the filter. If you have questions about whether your form of this medication may be used if it contains particles, or if you have other questions about the use of this medication, consult the doctor or pharmacist. Dosage is based on your medical condition (e.g., amount and location of bleeding), weight, and response to treatment. The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse. Learn how to store and discard needles and medical supplies safely. Tell your doctor if your condition persists or worsens.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that help with clotting (e.g., tranexamic acid). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., factor IX activity) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

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, 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 (e.g., disseminated intravascular coagulation-DIC), heart disease (e.g., coronary artery disease), immune system problems, recent surgery/procedure, liver disease. Before having surgery, tell your doctor or dentist that you are using this medication. Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent viral infections. Consult your doctor for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

This medication must be stored properly. Store vials of powder in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Review storage instructions for your specific product with the pharmacist. Check the expiration date before using. The vial of medication should only be used once. Throw away any unused portion. Keep all medicines 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 for more details about how to safely discard your product.

Pain at injection site, chills, tingling, flushing, headache, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: swelling at injection site, fast heartbeat, shortness of breath, change in the amount of urine, swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising. Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, trouble breathing, bluish fingers. This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that you may get infections from the medication (e.g., viral infections such as hepatitis). Tell your doctor immediately if you develop any signs of hepatitis/another infection, including fever, persistent sore throat, unusual tiredness, persistent nausea/vomiting, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.