Coagulation Factor X (human), Infusion

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KEY POINTS

• This medicine is given by IV to prevent or control bleeding in people who have hereditary Factor X deficiency.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihemophilic; coagulation factor

Generic and brand names: coagulation factor X, human, infusion; Coagadex

What is this medicine used for?

This medicine is given by IV to prevent or control bleeding in people who have hereditary Factor X deficiency.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is usually given by IV infusion (slow drip through a needle into a large vein) by your healthcare provider. You may be able to infuse this medicine yourself or with the help of someone at home. Your healthcare provider or a hemophilia center can teach you the proper way to give the infusions. If you take this medicine on a regular schedule, do not stop taking this medicine without your healthcare provider's approval.

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 12.

What if I miss a dose?

If you are taking this medicine on a schedule and you miss a dose, contact your healthcare provider.

What should I watch out for?

You may be at a higher risk of for developing a blood clot after treatment with this medicine. You will have several blood tests to check your blood clotting time. Keep all appointments.

Your body may make antibodies that prevent this medicine from working. Tell your healthcare provider if this medicine does not seem to be working as well as usual. If your bleeding is not controlled after you receive this medicine, contact your healthcare provider right away.

This medicine is made from human blood. It is tested for viruses such as hepatitis. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain; trouble breathing; unexplained cough; pain, redness, or swelling in your lower leg; swelling or pain in your hands or feet, or any unexplained swelling; sudden weight gain; trouble urinating or decreased urination; foamy urine; blood in the urine or bowel movement; unusual bruising or bleeding; severe dizziness or fainting.

Other: Change in sense of taste, mild headache, numbness or tingling in mouth, irritation at spot where the shot was given, tiredness, mild back pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aminocaproic acid (Amicar)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), edoxaban (Savaysa), fondaparinux (Arixtra), and rivaroxaban (Xarelto)
• Tranexamic acid (Cyklokapron, Lysteda)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How do I store this medicine?

Store the medicine without the diluent added to it in the refrigerator or at room temperature. Do not let it freeze. After you add the diluent to the medicine, use it within 1 hour. Discard any medicine left in the vial at the end of your infusion. Do not use the medicine after the expiration date printed on the vial. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.