Viral Safety With BeneFIX

Tests on donated blood and plasma have been mandated because
of the history of pathogen transmission through blood- and plasma-derived products

Some pathogens associated with blood products^46,47

Category	Examples
Lipid-enveloped viruses	Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)
Non–lipid-enveloped viruses	Hepatitis A virus (HAV), parvovirus B-19
Prion	Variant Creutzfeldt-Jakob disease (vCJD)

• Non–lipid-enveloped viruses are more resistant to viral inactivation processes (such as heating or solvent/detergent washes) than lipid-enveloped viruses^2,3
• Screening tests are currently under development for detecting prion diseases such as Creutzfeldt-Jakob disease (CJD) and vCJD⁴

BeneFIX is produced through recombinant technology in which the product is not derived from animal or human sources

"...[BeneFIX] is inherently free of human blood-borne pathogens, including any risk of human immunodeficiency virus (HIV), hepatitis, parvovirus, and Creutzfeldt-Jakob disease (CJD)."—Adamson et al⁵

"...there are justified concerns about the safety of large-pool blood protein concentrates for patients such as those with hemophilia for whom continuous usage results in exposure to millions of blood donors during one's life."—Roth et al⁶

• As many as 60,000 separate donations contribute to a single lot of plasma-derived product⁷
• The larger the size of the plasma pool for fractionated plasma-derived products, the greater the probability that blood-borne pathogens will be included⁷
• MASAC recommends that plasma pools be decreased in size to levels approaching 15,000 donations per lot of finished product²

BeneFIX is produced without human donors or animal proteins; it is therefore inherently free from the risk of transmission of human blood-borne pathogens

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.

Please see BeneFIX Prescribing Information

The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.