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Safety Matters

BeneFIX is the FIRST and ONLY recombinant factor IX, with no human or animal plasma or albumin used in the manufacturing process.

Free of blood-borne pathogens

Viral Safety Matters

How BeneFIX is manufactured

People with hemophilia B are missing a protein known as factor IX, which helps their blood to clot. To make BeneFIX, scientists produce this protein synthetically (outside of the body) using a process called recombinant technology.

The gene for factor IX was inserted into special production cells. The special production cells produce factor IX. The cells are multiplied to produce large amounts of the factor. The factor is later separated from the production cells, carefully purified, and dried. The result is the powder you see in BeneFIX vials — which can be reconstituted for your use.

 

Indication

BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X) nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information

  • As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or tiredness.
  • BeneFIX may be contraindicated in patients with a known history of hypersensitivity to hamster protein.
  • Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.
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