Coagulation factor XIII concentrate (human)

Generic Name: coagulation factor xiii concentrate (human) (koe-AG-yoo-LAY-shun FAK-tor THUR-teen)
Brand Name: Corifact

Coagulation factor XIII concentrate (human) is used for:

Preventing bleeding in patients with congenital factor XIII (FXIII) deficiency.

Coagulation factor XIII concentrate (human) is a human clotting factor derived from human plasma. It works by increasing the amount of clotting FXIII in the blood, which helps the blood form clots more normally and prevent bleeding.

Do NOT use coagulation factor XIII concentrate (human) if:

  • you are allergic to any ingredient in coagulation factor XIII concentrate (human) or to other products that are made from human plasma

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Before using coagulation factor XIII concentrate (human):

Some medical conditions may interact with coagulation factor XIII concentrate (human). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a blood clot, are at risk of developing blood clots, or have a history of blood clots
  • if you have a history of bleeding problems other than congenital FXIII deficiency

Some MEDICINES MAY INTERACT with coagulation factor XIII concentrate (human). However, no specific interactions with coagulation factor XIII concentrate (human) are known at this time.

Ask your health care provider if coagulation factor XIII concentrate (human) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use coagulation factor XIII concentrate (human):

Use coagulation factor XIII concentrate (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with coagulation factor XIII concentrate (human). Talk to your pharmacist if you have questions about this information.
  • Coagulation factor XIII concentrate (human) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using coagulation factor XIII concentrate (human) at home, a health care provider will teach you how to use it. Be sure you understand how to use coagulation factor XIII concentrate (human). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use coagulation factor XIII concentrate (human) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of coagulation factor XIII concentrate (human), contact your doctor right away.

Ask your health care provider any questions you may have about how to use coagulation factor XIII concentrate (human).

Important safety information:

  • Some patients have developed antibodies that decrease coagulation factor XIII concentrate (human)'s effectiveness. Discuss any questions or concerns with your doctor. Contact your doctor right away if you experience breakthrough bleeding while you are using coagulation factor XIII concentrate (human).
  • Coagulation factor XIII concentrate (human) is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using coagulation factor XIII concentrate (human). Discuss any questions or concerns with your doctor.
  • Lab tests, including blood FXIII levels, may be performed while you use coagulation factor XIII concentrate (human). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Coagulation factor XIII concentrate (human) should be used with extreme caution in the ELDERLY; safety and effectiveness in these patients have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using coagulation factor XIII concentrate (human) while you are pregnant. It is not known if coagulation factor XIII concentrate (human) is found in breast milk. If you are or will be breast-feeding while you use coagulation factor XIII concentrate (human), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of coagulation factor XIII concentrate (human):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; joint pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding or bruising at the injection site; chest, jaw, or left arm pain; confusion; decreased coordination; dizziness; fainting; fever or chills; light-headedness; numbness of an arm or leg; one-sided weakness; shortness of breath; slurred speech; stomach pain or swelling; sudden, severe headache or vomiting; symptoms of a blood clot in your leg or arm (eg, pain, tenderness, warmth, redness, swelling, lump); unusual or persistent bruising or bleeding (eg, nosebleeds); vision changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of coagulation factor XIII concentrate (human):

Coagulation factor XIII concentrate (human) is usually handled and stored by a health care provider. If you are using coagulation factor XIII concentrate (human) at home, store coagulation factor XIII concentrate (human) as directed by your pharmacist or health care provider. Keep coagulation factor XIII concentrate (human) out of the reach of children and away from pets.

General information:

  • If you have any questions about coagulation factor XIII concentrate (human), please talk with your doctor, pharmacist, or other health care provider.
  • Coagulation factor XIII concentrate (human) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take coagulation factor XIII concentrate (human) or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about coagulation factor XIII concentrate (human). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to coagulation factor XIII concentrate (human). This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using coagulation factor XIII concentrate (human).

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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