([coagulation factor IX (recombinant)])
BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution.
Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.
Patient Information
BeneFIX® / BEN-uh-fiks/
[Coagulation Factor IX (Recombinant)]
Please read this Patient Leaflet carefully before using BeneFIX and each time you get a refill. There may be new information. This Patient Leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is BeneFIX?
BeneFIX is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease.
BeneFIX is NOT used to treat hemophilia A.
What should I tell my doctor before using BeneFIX?
Tell your doctor and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.
Tell your doctor about all of your medical conditions, including if you:
How should I infuse BeneFIX?
The initial administrations of BeneFIX should be administered under proper medical supervision, where proper medical care for severe allergic reactions could be provided.
See the step-by-step instructions for infusing BeneFIX at the end of this leaflet. You should always follow the specific instructions given by your doctor. The steps listed below are general guidelines for using BeneFIX. If you are unsure of the procedures, please call your doctor or pharmacist before using.
Call your doctor right away if bleeding is not controlled after using BeneFIX.
Your doctor will prescribe the dose that you should take.
Your doctor may need to test your blood from time to time.
BeneFIX should not be administered by continuous infusion.
What if I take too much BeneFIX?
Call your doctor if you take too much BeneFIX.
What are the possible side effects of BeneFIX?
Allergic reactions may occur with BeneFIX. Call your doctor or get emergency treatment right away if you have any of the following symptoms:
Your body can also make antibodies, called "inhibitors," against BeneFIX, which may stop BeneFIX from working properly.
Some common side effects of BeneFIX are fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness and rash.
BeneFIX may increase the risk of thromboembolism (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter through which BeneFIX is given by continuous infusion. There have been reports of severe blood clotting events, including life-threatening blood clots in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter. The safety and efficacy of BeneFIX administration by continuous infusion have not been established.
These are not all the possible side effects of BeneFIX.
Tell your doctor about any side effect that bothers you or that does not go away.
How should I store BeneFIX?
DO NOT FREEZE BeneFIX kit.
BeneFIX kit can be stored at room temperature (below 86°F) or under refrigeration.
Throw away any unused BeneFIX and diluent after the expiration date indicated on the label.
Freezing should be avoided to prevent damage to the pre-filled diluent syringe.
BeneFIX does not contain a preservative. After reconstituting BeneFIX, you can store it at room temperature for up to 3 hours. If you have not used it in 3 hours, throw it away.
Do not use BeneFIX if the reconstituted solution is not clear and colorless.
What else should I know about BeneFIX?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use BeneFIX for a condition for which it was not prescribed. Do not share BeneFIX with other people, even if they have the same symptoms that you have.
This Patient Leaflet summarizes the most important information about BeneFIX. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BeneFIX that was written for healthcare professionals.
Additional Resources
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.
Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.
Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for a Pfizer medicine or a vaccine.
The submission will be reviewed during our standard business hours.
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.