Factor IX Complex Human (FAK-tor NINE KOM-plex HUE-man)

Prevents and controls bleeding in patients with hemophilia B (also known as Factor IX deficiency or Christmas disease).

Brand Name(s):

Profilnine

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.
• Take the medicine out of the refrigerator before you are ready to use it. This will let the medicine warm up to room temperature before use.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. Throw away old medicine after the expiration date has passed.
• 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 breast feeding.
• Make sure your doctor knows if you have liver disease or if you have recently had surgery.
• This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.
• 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
• Chest pain, trouble breathing, or coughing up blood.
• Fever, chills.
• Lightheadedness or fainting.
• Numbness or weakness in your arm, leg, or one side of your body.
• Pain in your lower leg (calf).
• Severe nausea, joint pains, skin rash, yellowing of skin or whites of your eyes.
• Sudden severe headache, problems with vision, speech, or walking.

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

• Nausea, or mild stomach pain.
• Pain, itching, swelling, burning 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