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Sirolimus Oral solution

It is used to decrease the immune system's response to a transplanted organ.

Generic Name: sirolimus  |  Brand Name: Rapamune

Brand Names: Rapamune

There is an FDA Alert for this drug. Click here to view it.

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

    Use Not Recommended in Liver or Lung Transplant Patients
  • Safety and efficacy of sirolimus as immunosuppressive therapy not established in liver or lung transplant patients; such use is not recommended. (See Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis in Liver Transplant Patients under Cautions and see Bronchial Anastomotic Dehiscence in Lung Transplant Patients under Cautions.)


FDA approved a REMS for sirolimus to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

SIROLIMUS (sir OH li mus) is used to decrease the immune system's response to a transplanted organ.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • high cholesterol or triglycerides
  • 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 use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Empty the correct amount of this medicine into a glass or plastic container with at least 2 ounces or 1/4 cup of water or orange juice. Do not mix with grapefruit juice or any other liquids. Stir well and drink. Refill the container with at least 4 ounces or 1/2 cup of water or orange juice, stir, and drink.

You may take this medicine with or without food, but choose one way and always take each dose the same way. If you are also taking cyclosporine, take this medicine at least 4 hours after taking your dose of cyclosporine. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

-certain antibiotics like clarithromycin, erythromycin, telithromycin
-grapefruit juice
-medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole
-mifepristone, RU-486
-rifabutin, rifampin
This medicine may also interact with the following medications:

-St. John's wort

What should I watch for while using this medicine?

Visit your doctor for regular checks on your progress. You will need frequent blood checks.

This medicine can cause your cholesterol or lipid levels to go up. You may need treatment for high cholesterol.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

This medicine may increase your risk of getting some cancers. Talk with your doctor.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Women who are able to have children should use effective birth control before, during, and for 12 weeks after stopping this medicine.

Last Updated: December 14, 2012
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