Factor IX Fc Fusion Protein Recombinant (FAK-tor NINE Fc FUE-zhun PROE-teen ree-KOM-bi-nant)

Helps prevent and control bleeding episodes in patients with hemophilia B.

Brand Name(s):

Alprolix

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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also store the vials at room temperature for up to 6 months. After reconstitution, you may store the medicine at room temperature for up to 3 hours. Throw away any reconstituted medicine not used within 3 hours.

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 or a history of blood clots.
• This medicine may cause 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.

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
• Blood in the urine, lower back or side pain, decrease in how much or how often you urinate, swelling of the feet or legs
• Chest pain, trouble breathing, coughing up blood
• Lightheadedness, dizziness, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)
• Unexplained bleeding, severe bruises that you cannot explain

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

• Pain 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