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Sirolimus is an immunosuppressant drug used to prevent the body from rejecting a transplanted organ. It is typically used in combination with other drugs to reduce the body’s natural immunity in patients who receive a kidney transplant.


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Before using this drug, talk to your doctor about the following precautions:

  • Do not eat raw oysters or other shellfish while you are taking sirolimus and take special care to ensure that oysters and shellfish are fully cooked. Even eating oysters from “clean” water or good restaurants does not guarantee that the oysters do not contain the bacteria.
  • If you can, avoid contact with people with colds or other infections.
  • Avoid other persons who have taken the oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective facemask that covers the nose and mouth.
  • Treatment with sirolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.
  • Grapefruits and grapefruit juice may increase the effects of sirolimus by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.

How sirolimus works

Sirolimus works by preventing the white blood cells from getting rid of the transplanted organ.

Taking sirolimus

  • Take sirolimus exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse or pharmacist to explain them to you.
  • Keep sirolimus in the container it came in, tightly closed and out of the reach of children.
  • Store tablets at room temperature and away from excess heat and moisture.
  • Keep liquid medication in the refrigerator, closed tightly, and throw away any unused medication one month after the bottle is opened.
  • Do not freeze.
  • If needed, you may store the pouches for up to 24 hours and the bottles for up to 15 days at room temperature.
  • Throw away any medication that is outdated or no longer needed, and talk to your pharmacist about the proper disposal of your medication.


If you miss a dose. When you start to take sirolimus, ask your doctor what you should do if you forget a dose, and write down these directions so that you can refer to them later. If you miss more than one dose, it is important that you call your doctor.

Over Dosage. In case of overdose, call your local poison control center. If the victim has collapsed or is not breathing, call local emergency services at 911.

Common side effects

Sirolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • back pain
  • difficulty falling asleep or staying asleep
  • fever
  • headache
  • joint pain
  • rash
  • stomach pain, constipation, diarrhea and/or vomiting
  • swelling of the hands, feet, ankles, or lower legs
  • tremor
  • weakness
  • weight gain

Dangerous side effects

If you experience any of the following symptoms, call your doctor immediately:

  • cough
  • pale skin
  • shortness of breath
  • unusual bleeding or bruising

Sirolimus and pregnancy

Although sirolimus has not been studied in pregnant women, it is not recommended for use during pregnancy because it may cause birth defects. Therefore, it is very important that an effective form of birth control be used before starting sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has stopped.

It is not known whether sirolimus passes into human breast milk. However, because this medicine may cause serious side effects, breast-feeding is not recommended while you are receiving it.

Drug interactions

Before taking sirolimus, tell your doctor if you are taking, have taken, or need to take any of the following medicines:

Amphotericin B (e.g. Abelcet, AmBisome, Amphocin, Fungizone); Antifungals such as clotrimazole (e.g. Lotrimin); Fluconazole (e.g. Diflucan); Itraconazole (e.g. Sporanox); Ketoconazole (e.g. Nizoral); Bromocriptine (e.g. Parlodel); Cimetidine (e.g. Tagamet); Cisapride (e.g. Propulsid); Clarithromycin (e.g. Biaxin); Cyclosporine (e.g. Neoral or Sandimmune); Danazol (e.g. Danocrine); Diltiazem (e.g. Cardizem, Dilacor, Tiazac); Erythromycin (e.g. E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (e.g. Crixivan); Ketoconazole (e.g. Nizoral); Carbamazepine (e.g. Tegretol); Phenobarbital (e.g. Luminal, Solfoton); Phenytoin (e.g. Dilantin); Metoclopramide (e.g. Reglan); Nicardipine (e.g. Cardene); Rifabutin (e.g. Mycobutin); Rifampin (e.g. Rifadin, Rimactane); Rifapentine (e.g. Priftin); Ritonavir (e.g. Norvir); St. John’s wort; tacrolimus (e.g. Prograf);Troleandomycin (e.g. TAO); Verapamil (e.g. Calan, Covera, Isoptin, Verelan); vitamins

Brand names

Rapamune, manufactured by Wyeth

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