Consumer Information for: BENEFIX

Usual dose

• Your doctor will decide the dose of BeneFIX you will receive.
• BeneFIX is injected directly into the bloodstream.
• The dose, duration and frequency of infusion will depend on your individual needs for replacement factor IX and may be influenced by your age, weight, activity level and severity of bleed.
• Your doctor may periodically need to check laboratory blood test results following infusion to be sure that blood level of factor IX is high enough to allow satisfactory blood clotting.
• If you have been using plasma-derived factor IX, the dose of BeneFIX may differ from the dose of plasmaderived factor IX.
• Do not lower the dose of BeneFIX without checking with your doctor, unless you are having an allergic reaction.

Overdose

• No symptoms of overdose are known.

Missed Dose

• If you miss a dose of this medicine, check with your doctor as soon as possible for instructions.

Preparation and Administration

RECONSTITUTION

Always wash your hands before performing the following procedures. Aseptic technique (meaning clean and germfree) should be used during the reconstitution procedure.
All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.

BeneFIX is administered by intravenous (IV) infusion after reconstitution with the supplied diluent (0.234% sodium chloride diluent).

1. If refrigerated allow the vial of lyophilized BeneFIX^® and the pre-filled diluent syringe to reach room temperature.
2. Remove the plastic flip-top cap from the BeneFIX^® vial to expose the central portions of the rubber stopper.



3. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.


4. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.


5. Place the vial on a flat surface. While holding the adapter in the package, place the vial adapter over the vial. Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper. Leave the adapter package in place.



6. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.



7. Remove the tamper-resistant, plastic-tip cap from the diluent syringe by bending the cap up and down to break the perforation. Do not touch the inside of the cap or the syringe tip. The cap may need to be replaced, so place the cap on its side on a clean surface in a spot where it would be least likely to become environmentally contaminated.



8. Lift the package away from the adapter and discard the package.



9. With the vial on a flat surface, connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.



10. Slowly depress the plunger rod to inject all the diluent into the BeneFIX^® vial.



11. With the syringe still connected to the adapter, gently swirl the contents of the vial until the powder is dissolved.


12. Inspect the final solution for specks before administration. The solution should appear clear and colorless.
    Note: If you use more than one vial of BeneFIX^® per infusion, reconstitute each vial by following the previous instructions.


13. Ensuring that the syringe plunger rod is still fully depressed, invert the vial. Slowly draw the solution into the syringe.
    
    Note: If you prepared more than one vial of BeneFIX^®, remove the diluent syringe from the vial adapter, leaving the vial adapter attached to the vial. Quickly attach a separate large luer lock syringe and draw back the reconstituted contents as instructed above. Repeat this procedure with each vial in turn. 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.



14. Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Discard the vial with the adapter attached.
    
    Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.

BeneFIX should be administered within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.

ADMINISTRATION (Intravenous Injection)

1. Attach the syringe to the luer end of the infusion set tubing provided.


2. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.



Once you learn how to self infuse you can follow the instructions in this insert.

3. Perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. The reconstituted BeneFIX product should be injected intravenously over several minutes. The rate of administration should be determined by the patient’s comfort level.



Reconstituted BeneFIX should not be administered in the same tubing or container with other medicinal products.

Following completion of BeneFIX treatment, remove the infusion set and discard. Dispose of all unused solution, empty vial(s), and used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX^®. No adverse events have been reported in association with this observation. To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe.

Note: If red blood cell agglutination is observed in the tubing or syringe, discard all material (tubing, syringe and BeneFIX^® solution) and continue administration with a new package.