Benefix -(1000IU): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

• hat the medication is used for:
• The control and treatment of bleeding and the prevention of bleeding in people with hemophilia B.
• BeneFIX^® has been approved for use in hemophilia B for adults and children.
• Ask your doctor if you have any questions about why BeneFIX^® has been prescribed for you.
• hat it does:
• Factor IX is a protein produced naturally in the body. It helps the blood form clots to stop bleeding.
• People with hemophilia B (Christmas disease) are deficient in coagulation factor IX.
• When the body does not make enough factor IX, and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints.
• Injections of factor IX are used to treat hemophilia B.

• BeneFIX^® is created using recombinant technology that allows it to be made without human blood or plasma products, making it naturally free of blood borne pathogens.

  • hen it should not be used:
  • Do not use BeneFIX^® for the treatment of other coagulation factor deficiencies (e.g., factors II, VII and X), for the treatment of hemophilia A, in patients with inhibitors to factor VIII, for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.
  • Do not use BeneFIX^® if you are allergic to hamster proteins or any of the nonmedicinal ingredients listed below.
  • Do not use BeneFIX^® after the expiry date (printed on the bottle). If you take this medicine after the expiry date has passed, it may not work well.
  • Do not use BeneFIX^® if the packaging is torn or shows signs of tampering.

If you are not sure whether you should use BeneFIX^®, talk to your doctor.

• hat the medicinal ingredient is:

  • Recombinant coagulation Factor IX (Nonacog alfa)

• hat the important nonmedicinal ingredients are:

  • Glycine
  • Sucrose
  • Histidine
  • Polysorbate 80
  • Sodium chloride solution

What dosage forms it comes in:

BeneFIX^® comes as a white powder in a glass vial, nominally containing 250, 500, 1000 and 2000 IU per vial. The actual amount of Factor IX is stated on the label of each bottle. BeneFIX^® must be reconstituted (dissolved) with the diluent syringe and the product contains approximately: 50, 100, 200 and 400 IU/mL, respectively.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Your bleeding does not stop as expected
• EFORE you use BeneFIX^® talk to your doctor or hemophilia treatment centre if you:

• Are pregnant or planning to become pregnant

• Are breast feeding or planning to breast feed
• Are at risk of developing blood clots
• Have liver disease
• Have recently had surgery or are planning to have surgery, including dental surgery

INTERACTIONS WITH THIS MEDICATION

• rugs that may interact with BeneFIX^® include:
• There are no known interactions of BeneFIX^® with other medications.
• Tell your doctor or pharmacist if you are taking any other medicines, including any you buy without a prescription, including natural health products.

PROPER USE OF THIS MEDICATION

• sual 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 plasma-derived factor IX.
• Do not lower the dose of BeneFIX^® without checking with your doctor, unless you are having an allergic reaction.
• verdose:
• No symptoms of overdose are known.
• issed 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 germ-free) 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. 1. Allow the vial of lyophilized BeneFIX^® and the pre-filled diluent syringe to reach room temperature.
2. 2. Remove the plastic flip-top cap from the BeneFIX^® vial to expose the central portions of the rubber stopper.

1. 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.

1. 4. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
2. 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.

1. 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.

   1. 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.
   2. 8. Lift the package away from the adapter and discard the package.
   3. 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.
   4. 10. Slowly depress the plunger rod to inject all the diluent into the BeneFIX^® vial.

1. 11. With the syringe still connected to the adapter, gently swirl the contents of the vial until the powder is dissolved.
2. 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.

1. 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.

1. 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. 1.

   Attach the syringe to the luer end of the provided infusion set tubing and infuse BeneFIX^® as instructed by your doctor or healthcare provider.

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

   After reconstitution, BeneFIX^® should be injected intravenously over several minutes. Your comfort level should determine the rate of administration.

   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.

   1. 2. After injecting BeneFIX^®, remove the infusion set and discard. The amount of drug product left in the infusion set will not affect your treatment. Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate container used for throwing away waste that might hurt others if not handled properly.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• During your treatment with BeneFIX^®, your blood will be checked for inhibitors to factor IX activity. Inhibitors are antibodies against Factor IX, which are made by your immune system. The inhibitors stop the factor IX from working as well as it used to.
• ell your doctor immediately if you are using increasing amounts of BeneFIX^® in order to control a bleed.
• Injection of any medicine intravenously may have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you experience some of the side effects in the table below.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

STOP taking BeneFIX^® and call your doctor immediately

9

Tell your doctor if you notice any of the following side effects and they worry you:

• Changes in your vision

These are all mild side effects of BeneFIX^® injection and will usually disappear on their own. Tell your doctor if you are concerned or if they continue.

This is not a complete list of side effects. For any unexpected effects while taking BeneFIX^®, contact your doctor or hemophilia treatment centre.

HOW TO STORE IT

Before preparation (BeneFIX^® powder):

Keep BeneFIX^® in the refrigerator (2°C to 8°C).

DO NOT freeze.

If stored at room temperature below 25°C, BeneFIX^® must be used within 6 months. Write the date on the package when you first store BeneFIX^® at room temperature.

Keep BeneFIX^® (and needles) where young children cannot reach it.

BeneFIX^® must be used by the expiry date on the label. Do not use BeneFIX^® beyond the date (month and year) printed on the label after the word “Expires”, even if it has been stored properly.

After preparation (BeneFIX^® solution):

To avoid bacterial contamination of the solution, use the reconstituted BeneFIX^® as soon as possible or within 3 hours.

REPORTING SUSPECTED SIDE EFFECTS

NOTE: Before contacting Health Canada, you should contact your physician or hemophilia treatment centre.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be requested by contacting the sponsor, Wyeth Canada:

Medical Information: 1-800-461-8844

After Hours Emergency: 1-800-361-1336

Last revised: 08/03/2006