Coagulation factor X (10) is a man-made protein similar to a natural protein in the body that helps the blood to clot.

Coagulation factor X is used to treat or prevent bleeding in people with hereditary factor X deficiency. This medication is for use in adults and children.

Coagulation factor X 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 and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Coagulation factor X is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Coagulation factor X must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Gently swirl but do not shake the medicine. The mixture should appear clear or slightly pearl-like. Do not use the mixed medicine if it looks cloudy or has particles in it. Prepare a new kit or call your pharmacist for a new kit.

Prepare your dose only when you are ready to give an injection. Use the injection within 1 hour after mixing your dose.

You will need frequent medical tests.

Tell your doctor if this medicine seems to stop working as well in preventing a bleeding episode.

You may store this medicine at room temperature or in a refrigerator. Protect from light and do not freeze. Keep the injection kit in its original package until you are ready to prepare an injection.

Throw away any unused coagulation factor X after the expiration date on the medicine label has passed.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Factor X Deficiency:

On-demand Treatment and Control:
25 international units/kg IV infusion at the first sign of bleeding; repeat every 24 hours until bleeding stops.

Maximum dose: 60 international units/kg/day


Perioperative Management:
Pre-surgery:
-Calculate and administer dose needed to increase Factor X levels to 70 to 90 international units/dL (required dose [international units] = body weight [kg] x desired Factor X increase [international units/dL] x 0.5).
Post-surgery:
-Repeat pre-surgery dose as needed to maintain Factor X levels at a minimum of 50 international units/dL until patient is no longer at risk of bleeding due to surgery.

Maximum dose: 60 international units/kg/day

Comments: Measure post-infusion Factor X levels before and after surgery.

Use: Perioperative bleeding management in patients with mild hereditary Factor X deficiency.

Usual Pediatric Dose for Factor X Deficiency:

12 YEARS OR OLDER:
On-demand Treatment and Control:
25 international units/kg IV infusion at the first sign of bleeding; repeat every 24 hours until bleeding stops.

Maximum dose: 60 international units/kg/day


Perioperative Management:
Pre-surgery:
-Calculate and administer dose needed to increase Factor X levels to 70 to 90 international units/dL (required dose [international units] = body weight [kg] x desired Factor X increase [international units/dL] x 0.5).
Post-surgery:
-Repeat pre-surgery dose as needed to maintain Factor X levels at a minimum of 50 international units/dL until patient is no longer at risk of bleeding due to surgery.

Maximum dose: 60 international units/kg/day

Comments: Measure post-infusion Factor X levels before and after surgery.

Use: Perioperative bleeding management in patients with mild hereditary Factor X deficiency.

You should not use coagulation factor X if you have had an allergic reaction to clotting factor medicine.

Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

Coagulation factor X is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Call your doctor for instructions if you miss a 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, itching, tingling; wheezing, tightness in your chest, difficult breathing; fast heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Coagulation factor X may cause serious side effects. Call your doctor at once if you have:

• burning, stinging, redness, or swelling where the medicine was injected;

• fever or chills, cough, body aches, lack of energy;

• new or worsened bleeding; or

• continued bleeding after treatment.

Common side effects of coagulation factor X may include:

• feeling tired;

• back pain; or

• pain or redness 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.

Other drugs may affect coagulation factor X, 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.