Factor IX complex

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.

Factor IX complex 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.

Factor IX complex is used to treat or prevent bleeding episodes in people with 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.

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX deficiency.

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.

Stop using factor IX and call your doctor at once if you have chest pain, weak or shallow breathing, headache, warmth or tingling, fast or slow heart rate, easy bruising, increased bleeding episodes, bleeding from a wound or where the medicine was injected, or feeling like you might pass out.

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.

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX deficiency.

To make sure factor IX complex is safe for you, tell your doctor if you have liver disease.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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 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.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

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

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

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

This list is not complete and other drugs may interact with factor IX. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.

Factor IX complex 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.

Factor IX complex 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.

Your doctor will perform blood tests to make sure factor IX deficiency is your specific clotting disorder. Factor IX complex 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 factor IX complex.

To make sure factor IX complex 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 this medicine 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.

Factor IX complex is not approved for use by anyone younger than 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 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.

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.

Stop using this medicine 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 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.

Usual Adult Dose for Factor IX Deficiency:

Units required to raise blood level percentages: 1.0 unit/kg x body weight (in kg) x desired increase (% of normal).
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.

Usual Adult Dose for Hemophilia B:

Units required to raise blood level percentages: 1.0 unit/kg x body weight (in kg) x desired increase (% of normal).
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.

Usual Adult Dose for Factor VII Deficiency:

Proplex T (only):
Units required to raise blood level percentages: 0.5 unit/kg x body weight (in kg) x desired increase (% of normal). Repeat dose every 4 to 6 hours as needed.
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40 to 60% of normal.

Usual Adult Dose for Hemophilia A with Inhibitors:

Proplex T (only):
Treatment of hemarthroses occurring in hemophiliacs with inhibitors to Factor VIII:
75 Factor IX units per kg of body weight.

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.

Applies to factor ix complex: intravenous solution reconstituted

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Headache.
• Tingling.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.