BeneFIX, nonacog alfa (rch) is a coagulation factor IX product that is produced by recombinant technology. Mammalian cells, which have the DNA for human coagulation factor IX put in them, are grown in large amounts in cell culture laboratories. These cells make recombinant human factor IX, which is released into cell culture media and then very highly purified. The recombinant factor IX does not contain any human blood, preservatives, or added animal or human components.
People with haemophilia B (Christmas disease) are deficient in coagulation factor IX. BeneFIX works by replacing factor IX to enable blood to clot.
BeneFIX is used for the control and treatment of bleeding and the prevention of bleeding in people with haemophilia B.
BeneFIX has been approved for use in haemophilia B. Ask your doctor if you have any questions about why BeneFIX has been prescribed for you.
There is no evidence that BeneFIX is addictive.
BeneFIX is not expected to affect your ability to drive a car or operate machinery.
Do not use BeneFIX if you are allergic to hamster proteins or any of the ingredients listed at the end of this leaflet.
Signs of allergy include a skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, blurred vision, shortness of breath and/or a swollen face. If any of these signs occur, stop using BeneFIX and see your doctor immediately, you may need urgent medical care.
Do not use BeneFIX after the expiry date (printed on the pack).
If you take this medicine after the expiry date has passed, it may not work as 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.
Certain people must use BeneFIX with caution. Ask your doctor for advice.
Tell your doctor if you:
1. are pregnant or planning to become pregnant.
2. are breast feeding or planning to breast-feed.
3. have liver disease or are at risk of developing clotting disorders other than haemophilia or have recently had surgery.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by BeneFIX, or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
BeneFIX is given as an injection directly into your veins, usually by yourself, a doctor, nurse, or other trained person.
BeneFIX contains no additives that would prevent the growth of bacteria once the powder is dissolved with sterile sodium chloride solution. For this reason, each vial of BeneFIX is for single use only, in one patient only. Discard any residue.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
When injecting BeneFIX, you must follow the detailed instructions provided in the leaflet inside the pack.
When you have finished injecting BeneFIX, discard the needle and syringe into a sharps container.
If you do not understand the instructions for injecting BeneFIX found in the carton, ask your doctor or pharmacist for help.
Your doctor will decide the dose of BeneFIX you will receive. The dose and duration will depend upon your individual needs for replacement factor IX therapy. If you have been using plasma-derived factor IX, the dose of BeneFIX may differ from the dose of plasma-derived factor IX.
Your doctor may decide to change the dose of BeneFIX you receive during your treatment.
Always wash your hands before doing the following procedures. Use germ-free methods during the making up procedure and during injection.
Use only the materials provided in the box for dissolving the BeneFIX powder with the sodium chloride solution and then injecting the BeneFIX solution.
Inject BeneFIX solution as soon as possible or within 3 hours after dissolving the powder.
The made-up solution may be stored at room temperature before injection.
Inject the BeneFIX solution intravenously over several minutes.
The rate of injection should be determined by your comfort level.
If you see clumping of red blood cells in the tubing or syringe, discard all this material (tubing, syringe and BeneFIX solution) and start again with a new package.
Clumping together of red blood cells in the tubing or syringe has been noticed sometimes when BeneFIX is being given to patients. No side effects have been reported when this clumping has occurred. To minimise the risk of clumping, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe.
Please dispose of all unused solution, empty vials and used needles and syringes into a sharps bin.
Immediately contact your doctor, or the Poisons Information Centre (tel: 131 126 in Australia, or tel: 0800 764 766 in New Zealand) if you inject more BeneFIX than your doctor recommends. Do this even if there are no signs of discomfort.
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.
Tell 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 side effects.
Tell your doctor if you notice any of the following and they worry you:
These are all mild side effects of BeneFIX injection and will usually disappear on their own. Tell your doctor if they continue.
If any of the following side effects happen, STOP taking BeneFIX and tell your doctor immediately:
These side effects could mean that you are having an allergic reaction. These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Keep BeneFIX in the refrigerator (2°C to 8°C). DO NOT freeze.
BeneFIX must be used by the expiry date on the label.
If stored at room temperature below 30°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.
A locked cupboard at least one and a half metres above the ground is a good place to store medicine.
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.
Medicines cannot be stored indefinitely.
To stop bacterial contamination of the solution, use the made-up BeneFIX as soon as possible or within 3 hours.
BeneFIX comes as a white powder in a glass vial.
Each vial of BeneFIX is provided with a pre-filled diluent syringe containing 0.234% sodium chloride solution and accessories required for making up the solution and injection. These include a sterile infusion set, a vial adapter, sticking plaster, a gauze pad and two (2) alcohol swabs.
Active ingredients: nonacog alfa
Inactive ingredients: glycine, sucrose, L-histidine, polysorbate 80 and sodium chloride solution (0.234%)