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General Information ⬇

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IMPORTANT WARNING:

Sirolimus may make it harder for you to fight infections and increase the risk that you will get a serious infection. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, frequent or painful urination, or other signs of infection.

Sirolimus may increase the risk that you will develop cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: new sores or changes on the skin; night sweats; swollen glands in the neck, armpits, or groin; unexplained weight loss; trouble breathing; chest pain; weakness or tiredness that does not go away; or pain, swelling, or fullness in the stomach.

Sirolimus may cause serious side effects or death in patients who have had liver or lung transplants. This medication is not recommended to prevent rejection of liver or lung transplants.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to sirolimus.

You will be given the Medication Guide when you begin treatment with sirolimus and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of taking sirolimus.

Use ⬆ ⬇

WHY is this medicine prescribed?

Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. It is also used to treat lymphangioleiomyomatosis (LAM; a rare lung condition). Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body's immune system.

HOW should this medicine be used?

Sirolimus comes as a tablet and a solution (liquid) to take by mouth. Take once a day, either always with food or always without food. Take sirolimus at around the same time every day.

Take sirolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably adjust your dose of sirolimus during your treatment.

Continue to take sirolimus even if you feel well. Do not stop taking sirolimus without talking to your doctor.

Sirolimus solution may develop a haze when refrigerated. If this happens, let the bottle stand at room temperature and gently shake it until the haze goes away. The haze does not mean that the medication is damaged or unsafe to use.

The solution must be diluted before use. Use the bottle adapter and syringe provided by the manufacturer to measure each dose. To dilute the liquid, add the measured dose to at least 2 ounces (60 milliliters) of water or orange juice just before taking it. Do not use any other liquids. Stir vigorously for 1 minute and drink right away. Read the written instructions that come with the medication. Ask your doctor or pharmacist if you have any questions about preparing or giving a dose of the solution.

Are there OTHER USES for this medication?

Sirolimus also is used sometimes to prevent organ rejection in people who have received heart, pancreas, or intestinal transplants. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special ⬆ ⬇

What SPECIAL PRECAUTIONS should I follow?

Before taking sirolimus,

What SPECIAL DIETARY instructions should I follow?

Avoid drinking grapefruit juice while taking this medication. Talk to your doctor or pharmacist about safety of eating grapefruit during sirolimus treatment.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects ⬆ ⬇

What SIDE EFFECTS can this medicine cause?

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

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

Sirolimus may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose ⬆ ⬇

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage ⬆ ⬇

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store tablets at room temperature and away from light, excess heat, and moisture (not in the bathroom).

Store the solution in the refrigerator, away from light and tightly closed. Do not freeze. Dispose of any unused medication one month after the bottle is opened. If needed, you may store the bottles for up to 15 days at room temperature. The solution may also be stored in a syringe at room temperature or in the refrigerator for up to 24 hours. Do not store diluted sirolimus solution.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Miscellaneous ⬆

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2026.