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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)

Controls and prevents bleeding episodes in people who have hemophilia B (Christmas disease), including during surgery. This medicine is blood clotting Factor IX.

Brand Name(s):

BeneFIX, Benefix

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to factor IX complex or hamster protein (found in drugs such as antihemophilic Factor VIII, darbepoetin alfa, or Aranesp®).

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
  • A nurse or other trained health professional 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.
  • Use a new needle and syringe each time you inject your medicine.

If a dose is missed:

  • Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

  • If you store this medicine at home, keep it in the refrigerator. Do not freeze. Prior to the expiration date, this medicine may also be stored at room temperature for up to 6 months. Be sure to write the date the product was placed at room temperature in the space provided on the outer carton. Do not use this medicine after the expiration date.
  • Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine away from children and 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 breast feeding. Tell your doctor if you are allergic to latex rubber.
  • Make sure your doctor knows if you have any bleeding disorders, liver disease, or have recently undergone surgery. Your child should not receive this medicine if your child is less than one month old.

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
  • Bluish colored skin.
  • Chest pain, shortness of breath, or coughing up blood.
  • Fever or chills.
  • Lightheadedness 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.
  • Unusual bleeding, bruising, or weakness.

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

  • Cough or changes in taste.
  • Diarrhea, vomiting, or nausea.
  • Dizziness or mild headache.
  • Redness, pain, swelling, itching, or rash where the shot was given.
  • Rash.
  • Warmth or redness in your face, neck, arms, or upper chest.

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: 11/4/2014
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