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sirolimus - oral, Rapamune (cont.)

USES: Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

HOW TO USE: Take this medication by mouth, usually once daily or as directed by your doctor. Swallow this medication whole. Do not crush, chew, or break the tablets. If you have nausea or an upset stomach, you may take this drug with food. However, you must choose one way (with food or without food) and always take this medication the same way so that your body always absorbs the same amount of drug. Consult your doctor or pharmacist for more details.Dosage is based on your weight, medical condition, blood test results (e.g., sirolimus trough levels), and response to treatment. Do not take more than 40 milligrams in any 24-hour period.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Also, do not stop taking this medication without your doctor's approval.Take this medication regularly in order to get the most benefit from it. It is important to take all doses on time to keep the amount of medicine in your body at a constant level. Remember to take it at the same time each day.The tablet and solution forms of this medication may deliver different amounts of medication. Do not switch between the tablet and solution forms without your doctor's permission and directions.Other medications (e.g., antibiotics, immunosuppressants) may also be prescribed to help prevent infection in your body and to help prevent rejection of the transplanted organ. Take these additional medications exactly as prescribed by your doctor.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.Inform your doctor if your condition worsens.

SIDE EFFECTS: See also Warning section.Diarrhea, joint pain, shaking, acne, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle pain/cramps, bone pain, increased thirst/hunger, frequent urination, vision changes, hearing problems (e.g., hearing loss, ringing in the ears), unusual tiredness/weakness, fast/slow/irregular heartbeat, easy bruising/bleeding, mental/mood changes, swelling ankles/feet, severe headache, dizziness, stomach/abdominal pain.Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, frothy urine, chest pain, shortness of breath, pain/redness/swelling of arms or legs, dark urine, yellowing eyes/skin, persistent nausea/vomiting.Sirolimus may slow wound healing after surgery. Tell your doctor immediately if you have signs that your surgery wound is not healing well (e.g., redness, swelling, pain). The risk of poor wound healing is higher if you are obese.Sirolimus may cause your cholesterol/triglycerides to increase. You may be required to have your cholesterol/triglycerides checked periodically and/or take another medication to control your cholesterol/triglycerides.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Sirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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