Drug Notebook

FDA Alerts

  • Only clinicians experienced in immunosuppressive therapy and the management of renal transplant patients should prescribe sirolimus.
  • Patients should be managed in facilities with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.
  • Immunosuppression may result in increased susceptibility to infection and possible development of lymphoma or other neoplasms.

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sirolimus
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(sih RO lim us)

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

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.

What is sirolimus?

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 should I discuss with my doctor before taking sirolimus?

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

You should not use this medication if you are allergic to sirolimus.

Before using sirolimus, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take sirolimus.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using this medication and for at least 12 weeks after your treatment ends. It is not known whether sirolimus passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medicine should not be given to a child younger than 13 years old.
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