When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you have had an allergic reaction to a coagulation factor or to products made from human blood.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• This medicine is usually given about once a month, depending on your recent blood test results.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how factor XIII works. Tell your doctor if you are also using factor VIIa.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease or a history of stroke or blood clots.
• This medicine may cause the following problems:
  
  • Blood clots
• Corifact® is made from donated human blood. There is a very small risk that it could contain a virus, although all medicines and donors are checked for viruses.
• Tell your doctor if this medicine does not prevent or stop bleeding as expected.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, or coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)
• Unexplained bleeding, severe bruises that you cannot explain

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain
• Pain under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088