Drugs A - Z

Sirolimus Oral tablet

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

Generic Name: sirolimus

Brand Names: Rapamune

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

    Immunosuppression
  • 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.)

REMS:

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 However, FDA later rescinded REMS requirements.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 or heart failure
  • 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 with a glass of water. Do not cut, crush or chew this medicine. Follow the directions on the prescription label. If you take the medicine with food, always take it with food. Do not take the medicine with grapefruit juice. 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 of age for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can, and call your doctor or health care professional. Call your doctor or health care professional if you vomit after a dose.

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, voriconazole
-mifepristone, RU-486
-rifabutin, rifampin
This medicine may also interact with the following medications:

-boceprevir
-bromocriptine
-carbamazepine
-cimetidine
-cisapride
-clotrimazole
-cyclosporine
-danazol
-diltiazem
-fluconazole
-indinavir
-metoclopramide
-nicardipine
-phenobarbital
-phenytoin
-rifapentine
-ritonavir
-St. John's wort
-telaprevir
-troleandomycin
-vaccines
-verapamil

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
Licensed from
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks, and other material contained on the Healthline Site ("Content"), its services, and any information or material posted on the Healthline Site by third parties are provided for informational purposes only. None of the foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately. Please read the Terms of Service for more information regarding use of the Healthline Site.
Advertisement