TACROLIMUS ORAL (PROGRAF) BOXED WARNING Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine on an EMPTY stomach, 1 hour before or 2 hours after the ingestion of food. * Dose adjustments should not be done without first consulting physician. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * This medicine may increase BLOOD SUGAR levels in diabetics, dose adjustment of diabetes medicine may be necessary. * It is important that your doctor monitors your BLOOD CELL COUNTS at regular intervals. * It is important that your doctor monitors your BLOOD STUDIES at regular intervals. * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight. * DO NOT take this medication if you are pregnant or intend to become pregnant. * Nursing mothers should be advised not to breastfeed. Other Common Side Effects: TOP High blood pressure; Low phosphorus level; Shakiness; Skin rash; Burning pain, tingling, or numbness; Swelling of the extremities; Nausea; Difficulty falling asleep; Headache; Diarrhea; Constipation; Vomiting; High potassium level; High blood sugar level; Low potassium level; Low magnesium level; Scanty urine production; Dizziness; Stomach discomfort or pain; Decreased appetite; Indigestion; Liver problems; Kidney function tests abnormalities; Changes in urination frequency or amount; Urinary tract infection; Anemia; Cough; Difficulty breathing; Itching; Joint pain; Accumulation of abdominal serous fluid; Muscle weakness; Back pain; Swelling of feet or lower legs; Fever; Infection; Generalized pain. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved