Corifact is used to prevent bleeding episodes in people with a hereditary bleeding disorder caused by a deficiency of Factor XIII.

Factor XIII (thirteen) 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. This medicine works by temporarily raising levels of these factor XIII in the blood to aid in clotting.

Corifact will not treat a bleeding episode that has already begun.

Corifact may also be used for purposes not listed in this medication guide.

You should not use Corifact if you are allergic to any medicine made with human plasma.

Before using Corifact, tell your doctor if you have liver disease.

You may be shown how to use an IV at home. Do not self-inject Corifact if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Call your doctor at once if you have new or worsening bleeding episodes, sudden numbness or weakness, chest pain, coughing up blood, problems with vision or speech, or pain, swelling, warmth, or redness in one or both legs.

Corifact is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Corifact is usually given once every 4 weeks. Follow your doctor's dosing instructions very carefully.

Corifact is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Allow the mixture to reach room temperature before giving the injection. Do not heat the medicine before using.

Corifact should look clear or slightly yellow in color. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Do not mix Corifact with other injectable medications in the same IV line.

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 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.

While using this medicine, you may need frequent blood tests.

Store unmixed Corifact in the refrigerator, do not freeze. Keep the medicine in its original container.

Unopened vials may also be stored at room temperature for up to 6 months, away from moisture, heat, and light. Do not refrigerate an unopened vial that has been stored at room temperature.

After mixing with a diluent, store at room temperature and use within 4 hours. Do not refrigerate or freeze.

Throw away any unused Corifact after the expiration date on the label has passed.

You should not use Corifact if you are allergic to factor XIII or to any medicine made with human plasma.

To make sure Corifact is safe for you, tell your doctor if you have:

• liver disease.

It is not known whether Corifact will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

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

Corifact 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.

Call your doctor for instructions if you miss a dose of Corifact.

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 any signs of an allergic reaction to Corifact: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening bleeding episodes;

• unusual bruising;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• 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 Corifact side effects may include:

• fever, chills, flu symptoms;

• stomach pain, vomiting, diarrhea,

• headache;

• joint pain;

• mild rash or itching; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 interact with factor XIII, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.