BENEFIX- coagulation factor ix (recombinant)
Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer
BeneFIX� , Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease).
BeneFIX, Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B.
BeneFIX, Coagulation Factor IX (Recombinant), is NOT indicated for:
treatment of other factor deficiencies (e.g., 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 liver-dependent coagulation factor
2.4 Instructions for Use
BeneFIX is administered by intravenous (IV) infusion after reconstitution of the lyophilized powder with the supplied pre-filled diluent (0.234% sodium chloride solution) syringe.
Patients should follow the specific reconstitution and administration procedures provided by their physicians.
For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling [see Patient Counseling Information (17) ].
Reconstitution, product administration, and handling of the administration set must be done with caution. Discard all equipment, including any reconstituted BeneFIX product, in an appropriate container. Place needles used for venipuncture in a sharps container after single use. Percutaneous puncture with a needle contaminated with blood from an infected patient can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.
Preparation
Always wash your hands before performing the following procedures.
Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
Use all components in the reconstitution and administration of this product as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.
Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted according to the following instructions. The diluent syringe should be removed leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted contents of each vial. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter