INDICATION
IMPORTANT SAFETY INFORMATION
BeneFIX, Coagulation Factor IX (Recombinant), is a
human blood coagulation factor indicated in adult
and pediatric patients with hemophilia B (congenital
factor IX deficiency or Christmas disease) for the
control and prevention of bleeding episodes and
peri-operative management.
• BeneFIX is contraindicated in patients who have manifested
life-threatening, immediate hypersensitivity reactions,
including anaphylaxis, to the product or its components,
including hamster protein.
Limitations of use:
BeneFIX is NOT indicated for:
• treatment of other factor deficiencies
(eg, factors II, VII, VIII and X),
• treatment of hemophilia A patients with inhibitors
to factor VIII,
• reversal of coumarin-induced anticoagulation,
• treatment of bleeding due to low levels of liverdependent coagulation factors.
• Hypersensitivity reactions, including anaphylaxis, have been
reported with BeneFIX. Closely monitor patients for signs and
symptoms of acute anaphylaxis, particularly during the early
phases of initial exposure to the product. Immediately
discontinue the administration of the product and initiate
appropriate treatment if symptoms occur.
• Patients may develop hypersensitivity to hamster (CHO)
protein as BeneFIX contains trace amounts.
• BeneFIX has been associated with the development of
thromboembolic complications, including patients receiving
continuous infusion through a central venous catheter. The
safety and efficacy of BeneFIX administration by continuous
infusion have not been established.