Coagulation Factor IX Recombinant, GlycoPEGylated (koh-a-gyoo-LAY-shun FAK-tor NINE ree-KOM-bin-ant, glye-koe-PEG-il-ay-ted)

Prevents and controls bleeding in patients with hemophilia B.

Brand Name(s):

Rebinyn

When This Medicine Should Not Be Used:

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.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Ask your doctor or pharmacist for instructions, if you need to use this medicine on a schedule.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or clotting disorders (including disseminated intravascular coagulation).
• This medicine may cause the following problems:
  • Increased risk for blood clots
  • Kidney problems
• Tell your doctor if this medicine does not prevent or stop bleeding as expected.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, coughing up blood
• Numbness or weakness in your arm or leg, or on one side of your body
• Sudden or severe headache, problems with vision, speech, or walking
• Unexplained bleeding

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

• 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