coagulation factor IX

What is the most important information I should know about coagulation factor IX?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is coagulation factor IX?

Coagulation factor IX is a man-made protein similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency.

Coagulation factor IX may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using coagulation factor IX?

• you have had an allergic reaction to clotting factor medicine;
• you have signs of excessive blood clotting; or
• you are allergic to hamster proteins.

To make sure coagulation factor IX is safe for you, tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• coronary artery disease (hardening of the arteries); or
• a heart attack or stroke.

Coagulation factor IX is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use coagulation factor IX?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Coagulation factor IX is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Coagulation factor IX is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear, yellow, or colorless. Do not use the mixed medicine if it has changed colors or has particles in it. Prepare a new kit or call your pharmacist for a new supply of coagulation factor IX.

Gently swirl but do not shake the medicine bottle when mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

Coagulation factor IX comes with patient instructions for proper mixing and storage. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using coagulation factor IX, you may need frequent blood tests.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Throw away any coagulation factor IX not used before the expiration date on the medicine label.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using coagulation factor IX?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of coagulation factor IX?

• swelling in your hands, feet, or ankles;
• swelling in your waist, weight gain;
• loss of appetite;
• fever or chills;
• continued bleeding after treatment;
• new or worsened bleeding; or
• signs of excessive blood clotting --sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth and redness in one or both legs.

Common side effects may include:

• nausea;
• headache;
• dizziness;
• altered sense of taste;
• mild skin rash; or
• pain, redness, itching, stinging, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect coagulation factor IX?

Other drugs may interact with coagulation factor IX, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about coagulation factor IX.