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Factor ix complex, recombinant (Injection)

Coagulation Factor IX Recombinant (koh-a-gyoo-LAY-shun FAK-tor NINE re-KOM-bin-ant)

Helps to prevent and control bleeding episodes and prevent bleeding during surgery in patients who have hemophilia B.

Brand Name(s):

BeneFIX, Benefix, Rixubis

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to a coagulation factor (recombinant) or to hamster proteins. You should not receive this medicine if you have disseminated intravascular coagulation (DIC) or if you have signs of fibrinolysis.

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • A nurse or other health provider will give you this medicine.
  • You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
    • Mix the medicine and fill your syringe:
    • This medicine is a powder that must be mixed with sterile water before you use it. There should be a bottle of sterile water in the package with the bottle of medicine.
    • Let the medicine and sterile water warm to room temperature before you mix them.
    • You will use the Baxject II device to mix the medicine and sterile water.
    • After you open the Baxject II package, push the clear plastic spike into the stopper on the bottle of sterile water. Do not take the blue cap off.
    • Turn the Baxject II and sterile water over, and push the white plastic spike into the bottle of medicine.
    • Do not shake the medicine and sterile water to mix them. Swirl the container gently.
    • The mixed solution should be clear and not have any color.
    • Take off the blue cap and attach your syringe. Fill the syringe and give yourself the medicine as you were taught.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

  • Ask your doctor or pharmacist for instructions, if you need to use this medicine on a schedule.

How to Store and Dispose of This Medicine:

  • Not mixed: Store the unopened package of medicine in the refrigerator. You may also keep it at room temperature for up to 6 months. Do not put the medicine back in the refrigerator if you have been storing it at room temperature.
  • Mixed: It is best to use the medicine right away after you have mixed the powder with the sterile water. You may keep it at room temperature for up to 3 hours after mixing, if needed.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or a history of medical problems caused by blood clots.
  • This medicine may increase your chance of developing blood clots. Tell your doctor right away if you have chest pain, trouble breathing, or pain, numbness or weakness in your legs or arms.
  • Call your doctor right away if you start to have bleeding problems, especially if this medicine has worked well for you before.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Change in how much or how often you urinate
  • Chest pain, trouble breathing, or coughing up blood
  • Lightheadedness, dizziness, or fainting
  • Numbness or weakness in your arm or leg, or on one side of your body
  • Pain in your lower leg (calf)
  • Sudden or severe headache, problems with vision, speech, or walking
  • Unexplained bleeding

If you notice these less serious side effects, talk with your doctor:

  • Change or loss of taste
  • Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 10/4/2014


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