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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

SIROLIMUS - ORAL

(sir-oh-LEE-muss)

COMMON BRAND NAME(S): Rapamune

WARNING: Sirolimus lowers the body's ability to fight an infection/disease (immunosuppression). This may increase your risk of developing an infection or certain types of cancer (e.g., skin cancer, lymphoma). To reduce the risk of these serious side effects, take this medication at the lowest effective dose as directed by your doctor. Keep all medical and laboratory appointments.

Tell your doctor immediately if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, unexplained weight loss, signs of infection (e.g., fever, persistent sore throat).

Sirolimus is not recommended for the prevention of rejection of liver or lung transplants because it has infrequently caused very serious (possibly fatal) liver/lung problems in those cases.

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: Read the Medication Guide provided by your pharmacist before you start taking sirolimus and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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.