Drugs & Vitamins

Rapamune Active Ingredients: Sirolimus Representative Names: Rapamune Available Product Images: What are sirolimus tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with sirolimus? What side effects may I notice from taking sirolimus? What should I watch for while taking sirolimus? Where can I keep my medicine? What are sirolimus tablets? (Back to top) SIROLIMUS (Rapamune®) is a medication used to decrease the immune system's response to a transplanted organ, which the body would otherwise see as foreign. Sirolimus helps to reduce immune responses and prevent organ rejection in patients who have received a kidney or other organ transplant. Generic sirolimus tablets are not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •heart disease, heart failure, or heart rhythm problems (fast or slow heartbeat) •high cholesterol or triglycerides •an active infection •liver disease •an unusual or allergic reaction to sirolimus, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Take sirolimus tablets by mouth once daily. Follow the directions on the prescription label. You may take sirolimus with or without food, but make sure to take it the same way all the time. Do not take your medicine more often than directed. If you are also taking cyclosporine, make sure to take sirolimus at least 4 hours after taking your dose of cyclosporine. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, take it as soon as you can. Remember if you are taking cyclosporine, you should wait at least 4 hours after taking cyclosporine before taking your sirolimus dose. Do not take double-doses. Contact your prescriber or health care professional if you miss more than one dose, or if you vomit after a dose. What drug(s) may interact with sirolimus? (Back to top) •amiodarone •bosentan •carbamazepine •cimetidine •cisapride •clarithromycin •cyclosporine •diltiazem •erythromycin •fluoxetine •fluvoxamine •grapefruit juice •imatinib •medicines for fungal infections (antifungal medicines applied to the skin should not interact) •medicines for HIV infection including protease inhibitors, delavirdine, efavirenz, and nevirapine •metoclopramide •micafungin •mifepristone •nefazodone •nicardipine •oxcarbazepine •phenobarbital •phenytoin •rifabutin •rifampin •rifapentine •St. John's wort •telithromycin •vaccines •verapamil Talk to your prescriber or health care professional before taking any of these medicines: •aspirin •acetaminophen •ibuprofen •ketoprofen •naproxen Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking sirolimus? (Back to top) Contact your prescriber or health care professional about any unusual effects. Side effects that you should report to your prescriber or health care professional as soon as possible: •difficulty breathing •rapid heart beat or chest pain •signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine •signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, and blood in the urine •signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness •skin rash or hives Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •acne •aches •diarrhea •difficulty sleeping •headache •nausea, vomiting What should I watch for while taking sirolimus? (Back to top) Sirolimus increases your cholesterol or lipid levels. This may require additional treatment in some cases. Your prescriber will check your blood levels on a regular basis while you are taking sirolimus to check for this effect. You will need to visit your prescriber or health care professional for regular checks on your progress. Sirolimus will decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Sirolimus may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bruising or bleeding. After you stop taking this medication, side effects can continue. Some side effects may not occur until years after the medicine was taken. These effects can include the development of certain types of cancer. Discuss this possibility with your prescriber or health care professional. Avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), ketoprofen (Orudis KT®), or naproxen (Aleve®) products as these may mask a fever, unless instructed to by your prescriber or health care professional. Patients who are able to have children should use effective birth control methods before, during, and for 12 weeks following sirolimus therapy. Where can I keep my medicine? (Back to top) Keep out of the reach of children. Store sirolimus tablets at room temperature. Last Updated:07/29/2005 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.