Sirolimus

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.

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.

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.

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.

Before taking sirolimus,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking sirolimus. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cyclosporine capsules or solution, take them 4 hours before sirolimus.
• the following nonprescription or herbal products may interact with sirolimus: cimetidine; St. John's wort; cannabidiol. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking sirolimus. Do not start any of these medications while taking sirolimus without discussing with your healthcare provider.
• tell your doctor if you have or have ever had high cholesterol or triglycerides, diabetes, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking sirolimus. Use effective birth control before starting treatment, during treatment, and for 12 weeks after your final dose. Talk to your doctor about the best birth control methods for you. If you become pregnant while taking sirolimus or within 12 weeks of your final dose, call your doctor immediately. Sirolimus may harm the fetus.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking sirolimus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sirolimus.
• do not have any vaccinations without talking to your doctor.

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

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.

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

• stomach pain
• headache
• constipation
• diarrhea
• nausea
• joint or muscle pain
• mouth sores
• acne

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:

• unusual bleeding or bruising
• new or worsening cough, shortness of breath, or difficulty breathing
• swollen, red, cracked, scaly. or peeling skin
• hives; rash; itching; difficulty breathing or swallowing; hoarseness; or swelling of the face, eyes, throat, tongue, or lips
• wound that is red, oozing pus, or slow to heal
• chest pain; trouble breathing; lightheadedness; fainting; or swelling of the belly, hands, feet, ankles, or lower legs
• weakness on one side of the body that worsens over time; clumsiness of the arms or legs; changes in your thinking, memory, walking, balance, eyesight, or strength that last several days; confusion; or personality changes
• pale skin, weakness, tiredness, shortness of breath, headache, or dizziness and fainting

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 https://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. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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.

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.

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