Factor IX complex

Factor IX (nine) is a protein found in the blood that helps it to clot. When there is a shortage of clotting factors, it can lead to uncontrolled bleeding because the blood cannot clot properly.

Factor IX complex is made up of four different clotting factors and other proteins. This medication works by temporarily increasing the levels of these clotting factors in the blood to help with clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with factor IX deficiency (hemophilia B). It is also used to manage bleeding during surgery or dental procedures in individuals with hemophilia B.

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

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

Your doctor will do blood tests to confirm that factor IX deficiency is your specific clotting disorder. Factor IX complex will not work for deficiencies of other blood-clotting factors.

Your doctor may recommend that you get a hepatitis vaccination before you start using factor IX complex.

To ensure factor IX complex is safe for you, inform 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 if factor IX complex could harm an unborn baby. Let your doctor know if you are pregnant or planning to become pregnant.

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

Factor IX complex is not approved for use by anyone under 18 years old.

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

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

factor IX complex may cause serious side effects. Stop using factor IX complex and call your doctor right away if you experience:

• sweating and feeling short of breath;
• feeling light-headed, as if you might pass out;
• easy bruising or more bleeding episodes;
• bleeding from a wound or where the medicine was injected;
• signs of a blood clot in the lung, such as chest pain, sudden cough, wheezing, rapid breathing, or coughing up blood; or
• signs of a blood clot in your leg, including pain, swelling, warmth, or redness in one or both legs.

Common side effects of factor IX complex may include:

• headache;
• flushing (warmth, redness, or a tingly feeling);
• nausea or vomiting;
• fever or chills; or
• lack of energy.

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

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

Factor IX complex 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 factor IX complex. 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 factor IX complex, 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.

Since factor IX complex is sometimes used as needed, you may not have a regular dosing schedule. If you do have a schedule, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to make up for the missed dose.

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

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Tell your doctor about all other medicines you are taking, especially:

• aminocaproic acid (Amicar); or
• tranexamic acid (Cyklokapron, Lysteda).

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