SIROLIMUS ORAL (RAPAMUNE) BOXED WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS See Full Prescribing Information for complete Boxed Warning. • Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamune. • The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended: – Liver Transplantation - Excess mortality, graft loss, and hepatic artery thrombosis. – Lung Transplantation - Bronchial anastomotic dehiscence BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * It is important to take this medication at the same time each day with respect to meals. * SOLUTION: MIX with WATER or ORANGE JUICE ONLY. DO not mix with any other juices or liquids. * If taking cyclosporin, take this medication FOUR HOURS after your cyclosporin dose. 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. * Notify your doctor if signs of INFECTION develops (eg, fever, sore throat, chills, or unusual bruising or bleeding). * AVOID GRAPEFRUIT while taking this medicine. * AVOID sources of INFECTION. This medication weakens your body's immune system and increases your risk of infection. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * It is important that you do not stop taking your medications without consulting your doctor. * Vaccination may be less effective while taking this medication. Avoid taking live attenuated vaccines. * This medicine may cause increased sensitivity to the sun. Take protective measures (sunscreens, protective clothing) against exposure. * SPECIAL POPULATIONS: * Women of childbearing potential should use effective CONTRACEPTION BEFORE, DURING and for 12 weeks AFTER treatment. * Pediatric: The appropriate dosing and safety have not been established below the age of 13 years old. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Swelling usually of face or lips; Severe allergic reaction. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Hypersensitivity reactions. Other Common Side Effects: TOP Headache; Joint pain; Shakiness; Weight gain; Muscle weakness; Swelling of the extremities; Indigestion; Constipation; Diarrhea; Difficulty breathing; Scaling and shedding of skin; Low potassium level; Low phosphorus level; High triglycerides level; High cholesterol level; High blood pressure; Acne; Stomach discomfort or pain; Anemia; Back pain; Chest pain; Swelling of feet or lower legs; Fever; Difficulty falling asleep; Nausea; Inflammation of the pharynx; Skin rash; Urinary tract infection; Vomiting. 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