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Sirolimus oral

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.




WARNING: This medication may make you more likely to develop an infection or certain types of cancer (e.g., lymphoma, skin cancer). Notify your doctor immediately if you develop any signs of infection such as fever, chills, sore throat, white patches in your mouth or a change in vaginal discharge. Also notify your doctor immediately if you have unusual lumps, swollen glands, unusual sweating or unexplained weight loss. When sirolimus has been used in liver transplants, an infrequent but potentially fatal liver problem has occurred (hepatic artery thrombosis). Use of this medication to prevent rejection of liver transplants is not recommended. Notify your doctor immediately if you develop: dark urine, stomach pain, yellowing eyes or skin, extreme fatigue or nausea. When sirolimus has been used in lung transplants, an infrequent but potentially fatal lung problem has occurred (bronchial anastomotic dehiscence). Use of this medication to prevent rejection of lung transplants is not recommended. Notify your doctor immediately if you develop: difficulty breathing.


This medication is used to prevent the rejection of transplanted organs (e.g., kidney).

How To Use

Take this medication by mouth once daily, exactly as prescribed by your doctor. The dosage depends on your condition and response to therapy. Learn all preparation and usage instructions in the product package. Ask your doctor or pharmacist if you have questions about any of the information. Mix the prescribed dose of this medication with at least two ounces (1/4 cup, 60 ml) of water or orange juice in a plastic or glass container. Stir vigorously and drink immediately. Refill the container with at least four more ounces (1/2 cup, 120 ml) of water or orange juice, stir vigorously and drink immediately. Do not use grapefruit juice to dilute this medication. Avoid grapefruit juice while using this medication unless your doctor specifically instructs you otherwise. This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals (e.g., every 24 hours) and take this drug consistently with or without food. Other medications (e.g., antibiotics, other immunosuppressants such as cyclosporine) may be prescribed to prevent infections, and prevent rejection of the transplanted organ. Take these medications exactly as prescribed by your doctor. If you use certain generics/types of cyclosporine (e.g., Neoral, SangCya), take sirolimus four hours after your dose of cyclosporine. Consult your pharmacist for more information. If a syringe is used to measure the prescribed dose, use a new syringe for each dose. Discard used syringes safely and properly.

Side Effects

Nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if you have any of these serious side effects: signs of infection such as fever or persistent sore throat, unexplained weight loss, unusual lumps or swollen glands, severe headache, unusual tiredness or weakness, unusual bleeding or bruising, muscle/joint/back pain, unusually fast/slow/irregular pulse, swelling, dizziness, rash. Tell your doctor immediately if you have any of these highly unlikely but very serious side effects: a change in the amount of urine. If you notice other effects not listed above, contact your doctor or pharmacist.


Tell your doctor your medical history, including: any allergies, liver problems, high blood levels of cholesterol or triglycerides. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received oral polio vaccine. Avoid prolonged sun exposure, tanning booths, or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Women of childbearing age should use effective birth control methods before starting this drug, during the use of this drug and for 12 weeks after stopping therapy with this drug. Consult your doctor or pharmacist for more information. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is passed into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially of: drugs for high cholesterol or triglycerides (e.g., lovastatin, atorvastatin, gemfibrozil), calcium-channel blockers (e.g., diltiazem, verapamil, nicardipine), rifamycins (e.g., rifampin, rifabutin), macrolide antibiotics (e.g., clarithromycin, erythromycin), aminoglycoside antibiotics (e.g., gentamicin, tobramycin), antifungal drugs (e.g., ketoconazole, fluconazole, amphotericin B), St John's wort, seizure medications (e.g., phenytoin, phenobarbital, carbamazepine), stomach or ulcer medications (e.g., metoclopramide, cisapride, cimetidine), bromocriptine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir). Do not start or stop any medicine without doctor or pharmacist approval.


If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include irregular heartbeat.


Do not share this medication with others. Keep all scheduled medical appointments. Laboratory and medical tests will be performed to monitor your progress.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.


Store at refrigerator temperature between 36 and 46 degrees F (2 to 8 degrees C) away from light and moisture. Once opened, bottles containing this drug should be used within 30 days. When refrigerated, this product may develop a slight haze. If this haze occurs, allow the drug to stand at room temperature and shake gently until the haze disappears. The haze does not affect the quality of the drug.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).