What Is BeneFix?
BeneFix® Coagulation Factor IX (Recombinant) 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.
Important Safety Information for BeneFix
- BeneFix is contraindicated in patients who have
manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis,
to the product or its components, including hamster protein.
- Call your health care provider right away if your bleeding is not controlled after
- Allergic reactions may occur with BeneFix. Call
your health care provider or get emergency treatment right away if you have any
of the following symptoms: wheezing, difficulty breathing, chest tightness, your
lips and gums turning blue, fast heartbeat, facial swelling, faintness, rash or
- Your body can make antibodies, called "inhibitors," which may interfere with the
effectiveness of BeneFix.
- If you have risk factors for developing blood clots, such as a venous catheter through
which BeneFix is given by continuous infusion, BeneFix may increase the risk of abnormal blood clots.
The safety and efficacy of BeneFix administration
by continuous infusion have not been established.
- Some common side effects of BeneFix are nausea,
injection site reaction, injection site pain, headache, dizziness and rash.
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or call 1-800-FDA-1088.
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The health information contained herein is provided for educational purposes only
and is not intended to replace discussions with a health care provider. All decisions
about patient care must be made with a health care provider, considering the
unique characteristics of the patient.
The product information provided in this site is intended for residents of
the United States. The products discussed herein may have different product labeling
in different countries.