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. factor XIII works by temporarily raising levels of these factor XIII in the blood to aid in clotting.

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

Factor XIII will not treat a bleeding episode that has already begun.

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

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

Factor XIII is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject factor XIII 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.

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

Factor XIII 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.

Factor XIII 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 factor XIII 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 factor XIII, you may need frequent blood tests.

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

Unopened vials of factor XIII 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 factor XIII with a diluent, store at room temperature and use within 4 hours. Do not refrigerate or freeze.

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

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

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

• liver disease.

It is not known whether factor XIII 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.

Factor XIII 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 factor XIII.

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; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Factor XIII may cause serious side effects. 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 side effects of factor XIII 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.