Sirolimus

Generic Name: sirolimus (sir-OH-li-mus)
Brand Name: Rapamune

Sirolimus decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever), any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.

Sirolimus may increase the risk of severe side effects, including death, when used with certain other immunosuppressants in liver or lung transplant patients. Use of sirolimus in liver or lung transplant patients is not recommended.


Sirolimus is used for:

Preventing organ rejection after a kidney transplant. It is used with other medicines. It may also be used for other conditions as determined by your doctor.

Sirolimus is an immunosuppressant. It works by blocking the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Do NOT use sirolimus if:

  • you are allergic to any ingredient in sirolimus
  • you have had a liver or lung transplant
  • you are taking clarithromycin, enzalutamide, erythromycin, itraconazole, ketoconazole, mifepristone, posaconazole, rifabutin, rifampin, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using sirolimus:

Some medical conditions may interact with sirolimus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, kidney problems, high cholesterol or triglycerides, low blood platelet levels, diabetes, or a history of lung or breathing problems
  • if you are on dialysis, have recently received or are scheduled to receive a vaccine or have a history of tuberculosis (TB), or have ever had a positive TB skin test
  • if you have had multiple organ transplants, an organ retransplanted, or a previous transplant that was rejected
  • if you or a family member has a history of skin cancer
  • if you previously took cyclosporine and have recently stopped taking it
  • if you take medicines that may harm the kidney (eg, aminoglycosides [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], vancomycin). Ask your doctor or pharmacist if you are unsure if any of your medicines might harm the kidney

Some MEDICINES MAY INTERACT with sirolimus. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for abortion, cancer, Cushing syndrome, endometriosis, fibrocystic breast disease, hepatitis C, hereditary angioedema, high blood pressure, high blood prolactin levels, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, Parkinson disease, seizures, stomach acid, ulcers or other stomach or bowel problems), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with sirolimus.

This may not be a complete list of all interactions that may occur. Ask your health care provider if sirolimus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use sirolimus:

Use sirolimus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sirolimus comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get sirolimus refilled.
  • You may take sirolimus by mouth on an empty stomach or with food. However, you must take it the same way each time for it to work best. If you take sirolimus on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
  • Swallow sirolimus whole. Do not break, crush, or chew before swallowing. If you cannot swallow sirolimus whole, check with your doctor.
  • Wash your hands immediately after taking sirolimus.
  • If you are also taking cyclosporine, take sirolimus 4 hours after your cyclosporine dose unless your doctor tells you otherwise.
  • Grapefruit and grapefruit juice may increase the risk of side effects from sirolimus. Do not eat grapefruit or drink grapefruit juice while taking sirolimus.
  • Sirolimus works best if it is taken at the same time each day. Continue to take sirolimus even if you feel well. Do not miss any doses.
  • Do not stop taking sirolimus without first checking with your doctor.
  • If you miss a dose of sirolimus, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use sirolimus.

Important safety information:

  • Do not change your dose of sirolimus without first checking with your doctor.
  • Sirolimus may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Some patients treated with sirolimus have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine). Discuss any questions or concerns with your doctor.
  • Sirolimus may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Discuss any questions or concerns with your doctor.
  • To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking sirolimus. Talk with your doctor before you receive any vaccine.
  • Sirolimus may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Do not switch between the tablet and solution forms of sirolimus without first checking with your doctor. The same doses may not be equally effective.
  • Tell your doctor or dentist that you take sirolimus before you receive any medical or dental care, emergency care, or surgery.
  • If you may become pregnant, you must use an effective form of birth control before you start taking sirolimus. You will need to continue to use birth control while you take sirolimus and for 12 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.
  • Decreased sperm production has occurred in some men taking sirolimus. Normal sperm production has usually returned when sirolimus was stopped. Discuss any questions or concerns with your doctor.
  • Patients who take sirolimus after an organ transplant may have an increased risk of developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Lab tests, including complete blood cell counts, kidney function, urine protein, blood cholesterol and triglyceride levels, and sirolimus blood levels, may be performed while you take sirolimus. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sirolimus should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Sirolimus may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking sirolimus while you are pregnant. It is not known if sirolimus is found in breast milk. Do not breast-feed while taking sirolimus.

Possible side effects of sirolimus:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; joint pain; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, eyes, lips, or tongue; unusual hoarseness; wheezing); calf or leg pain, redness, tenderness, or swelling; chest pain; fainting; fast or irregular heartbeat; menstrual changes; muscle pain, cramps, or tenderness; new or worsening breathing problems (eg, shortness of breath); new or worsening cough; night sweats; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; skin growths or discoloration; swelling of the hands, ankles, feet, or stomach; swelling or soreness of the mouth or tongue; symptoms of infection (eg, chills, fever, frequent or painful urination, sore throat, unusual vaginal discharge or odor); symptoms of kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight changes; vision changes; wound healing problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of sirolimus:

Store sirolimus at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container, away from heat, moisture, and light. Do not store in the bathroom. If sirolimus comes in a blister container, keep the tablets in the original container and use the outer carton to protect from light. Do not use after the expiration date. Keep sirolimus out of the reach of children and away from pets.

General information:

  • If you have any questions about sirolimus, please talk with your doctor, pharmacist, or other health care provider.
  • Sirolimus is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sirolimus or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sirolimus. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sirolimus. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using sirolimus.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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