Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Profilnine is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Profilnine is used to treat or prevent bleeding episodes in people with factor IX deficiency (hemophilia B). It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

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

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.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Profilnine 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.

Always check the strength of the medicine on the label to be sure you are using the correct potency.

Wash your hands before preparing and giving your injection.

Factor IX must be mixed with a liquid (diluent) before using it. Take the medicine and diluent out of the refrigerator and allow them to reach room temperature before mixing your dose. Do not heat the medicine or diluent. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve. Use the medicine as soon as possible after mixing.

You may store mixed medicine at room temperature but you must use it within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or looks cloudy. Call your pharmacist for new medication.

A single dose of factor IX may be enough to control minor bleeding. If you need a second dose, wait at least 24 hours before using the medicine again.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

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.

Use a disposable needle and syringe 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.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.

Your body may develop antibodies or "inhibitors" to Profilnine. When the body develops antibodies or "inhibitors" to the clotting factor, this treatment becomes less effective in preventing bleeding episodes.

Call your doctor if this medicine seems to be less effective in controlling your bleeding.

While using Profilnine, you may need frequent blood tests.

Store Bebulin and its diluent in a refrigerator. Do not freeze.

Store Profilnine and its diluent at room temperature, away from moisture and heat.

Throw away any unused medicine or diluent after the expiration date on the label has passed.

Your doctor will perform blood tests to make sure factor IX deficiency is your specific clotting disorder. Profilnine would not be effective in treating deficiencies of other blood-clotting factors.

Your doctor may want you to receive a hepatitis vaccination before you start using Profilnine.

To make sure Profilnine is safe for you, tell your doctor if:

• you have liver disease;

• you are allergic to latex;

• you have recently had surgery; or

• you are scheduled to have surgery.

It is not known whether Profilnine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Profilnine is not approved for use by anyone younger than 18 years old.

Profilnine 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.

Since Profilnine is sometimes used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction: hives or rash; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Profilnine may cause serious side effects. Stop using Profilnine and call your doctor at once if you have:

• sweating and feeling short of breath;

• a light-headed feeling, like you might pass out;

• easy bruising, increased bleeding episodes;

• bleeding from a wound or where the medicine was injected;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of Profilnine may include:

• headache;

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting;

• fever, chills; or

• lack of energy.

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.

Tell your doctor about all other medicines you use, especially:

• aminocaproic acid (Amicar); or

• tranexamic acid (Cyklokapron, Lysteda).

This list is not complete. Other drugs may interact with factor IX complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.