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Safety Matters

BeneFIX is a recombinant factor IX, with no added human or animal plasma or albumin used in the manufacturing process.

Free of blood-borne pathogens

Advancing Viral Safety

The only recombinant factor IX available to patients

BeneFIX is not derived from human blood and contains no preservatives or added animal or human components

  • No human or animal proteins are added during the purification and formulation process of BeneFIX
  • Chinese hamster ovary (CHO) cells used to manufacture BeneFIX are grown in media containing no added human or animal components

BeneFIX is a leader in recombinant therapy for hemophilia B, with over 12 years of experience*

*BeneFIX was approved February 11, 1997.

The manufacturing process for BeneFIX includes multiple purification steps

The production process is designed with viral safety in mind:

  • Use of well-characterized CHO cells
  • Extensive testing of production strain—shown to be free of known infectious agents
  • A manufacturing process and formulation that does not use blood or plasma products
  • A purification process that involves using multiple chromatography steps and nanofiltration
 

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.

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 using BeneFIX.
  • 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 hives.
  • 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.