FACTOR IX, HUMAN RECOMBINANT - INJECTION
Common Brand Name(s): Benefix
Phonetic Pronunciation: (FACK-ter nine)
Information last revised August 2010
What does FACTOR IX, RECOMBINANT - INJ look like?

BeneFIX 1,000 unit IV Kit
Uses:
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 treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).
Missed Dose
If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.
How To Use
This medication is given by injection into a vein over several minutes 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. If either is present, do not use the liquid. If you have 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. When using this medication, it is important to limit the amount of blood entering the tubing and to avoid letting any blood enter the syringe. You may need to use a new vial of medication and new set of supplies if this occurs. Consult the pharmacist for details. 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.
Drug Interactions
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.
Medical Alert
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).
Notes
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.
Overdose
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.
Precautions
Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or to hamster protein; or if you have any other allergies. This product may contain inactive ingredients (such as latex), 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), recent surgery/procedure, liver disease. Before having surgery, tell your doctor or dentist that you are using this medication. 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.
Storage
Store vials of powder in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. The vials of powder can also be stored at room temperature no higher than 77 degrees F (25 degrees C) for up to 6 months. Make sure to write down the date the medication was first stored at room temperature. After mixing, the medication can be stored at room temperature and should be used within 3 hours. The vial of medication should be used only 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.
Side Effects
Fever, pain at injection site, chills, headache, flushing, weakness, 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, shortness of breath, fast heartbeat, 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: bluish fingers, chest pain, trouble breathing. 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.
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
The information contained in the First DataBank databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counselling information. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. First DataBank disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose.
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