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• Prograf^®

Tacrolimus injection is used along with other medications to prevent rejection (attack of the transplanted organ by the transplant recipient's immune system) in people who have received kidney, liver, or heart transplants. Tacrolimus injection should only be used by people who are unable to take tacrolimus by mouth. Tacrolimus injection is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

Tacrolimus injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• uncontrollable shaking of a part of the body
• diarrhea
• constipation
• nausea
• vomiting
• heartburn
• stomach pain
• loss of appetite
• difficulty falling asleep or staying asleep
• dizziness
• weakness
• back or joint pain
• burning, numbness, pain or tingling in the hands or feet

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• decreased urination
• pain or burning on urination
• swelling of the arms, hands, feet, ankles or lower legs
• weight gain
• unusual bleeding or bruising
• seizures
• coma (loss of consciousness for a period of time)

Tacrolimus injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).