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Brand Names: Rapamune

Generic Name: sirolimus (Pronunciation: sih RO lim us)

• What is sirolimus (Rapamune)?
• What are the possible side effects of sirolimus (Rapamune)?
• What is the most important information I should know about sirolimus (Rapamune)?
• What should I discuss with my doctor before taking sirolimus (Rapamune)?
• How should I take sirolimus (Rapamune)?
• What happens if I miss a dose (Rapamune)?
• What happens if I overdose (Rapamune)?
• What should I avoid while taking sirolimus (Rapamune)?
• What other drugs will affect sirolimus (Rapamune)?
• Where can I get more information?

What is sirolimus (Rapamune)?

Sirolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Sirolimus is used to prevent your body from rejecting a transplanted kidney. Sirolimus is sometimes used in a combination treatment with cyclosporine (Neoral, Sandimmune) and a steroid medicine such as prednisone.

Sirolimus may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sirolimus (Rapamune)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fast heart rate;
• pain when you breathe, feeling short of breath;
• chest pain, feeling weak or tired;
• coughing up blood or mucus;
• feeling like you might pass out;
• pale skin, easy bruising or bleeding, weakness;
• fever, chills, body aches, flu symptoms;
• night sweats, weight loss;
• swelling in your face, stomach, hands or feet;
• rapid weight gain;
• pain or burning when you urinate; or
• slow healing of a wound.

Less serious side effects may include:

• joint pain;
• nausea, vomiting, diarrhea, constipation, stomach pain;
• headache; or
• acne or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sirolimus (Rapamune)?

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use an effective form of birth control while you are using this medication and for at least 12 weeks after your treatment ends.

The oral liquid form of sirolimus must be mixed with water or orange juice only. Do not use any other liquids to mix this medicine.

Do not mix this medicine with grapefruit juice or potentially dangerous effects may result. Avoid eating grapefruit or drinking grapefruit juice while you are taking sirolimus.

If you also take cyclosporine, take the sirolimus at least 4 hours after taking cyclosporine.

You may take sirolimus with or without food, but take it the same way every time.

Sirolimus can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines without your doctor's advice. Contact your doctor immediately if you develop signs of infection.

Avoid getting this medication on your skin, or around your nose and mouth. If it does get onto any of these areas, wash with soap and water. If this medicine gets into your eyes, rinse them with plain water.

Sirolimus may increase your risk of developing lymphoma or other forms of cancer. Talk with your doctor about your specific cancer risk.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Sirolimus may increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.