Sirolimus weakens your body's immune system, to help keep it from "rejecting" a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Sirolimus is used with other medicines to prevent organ rejection after a kidney transplant.

Sirolimus is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (lim-FAN-gee-oh-LYE-oh-MYE-oh-ma-TOE-sis). This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

Sirolimus may also be used for purposes not listed in this medication guide.

You should not use sirolimus if you have ever had a lung transplant or liver transplant.

Sirolimus may cause your body to overproduce white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Call your doctor right away if you have: fever, flu symptoms, burning when you urinate, a new skin lesion, any change in your mental state, decreased vision, weakness on one side of your body, problems with speech or walking, or pain around your transplant.

Sirolimus comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day, either always with food or always without food. To help you remember to take sirolimus, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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, usually not more than once every 7 to 14 days.

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.

To use the bottles of solution, follow these steps:

1. Open the solution bottle. On first use, insert the plastic tube with stopper tightly into the bottle until it is even with the top of the bottle. Do not remove from the bottle once inserted.
2. For each use, tightly insert one of the amber syringes, with the plunger fully pushed in, into the opening in the plastic tube.
3. Draw up the amount of solution your doctor has prescribed by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the correct mark on the syringe. Keep the bottle upright. If bubbles form in the syringe, empty the syringe into the bottle and repeat this step.
4. Empty the syringe into a glass or plastic cup containing at least 2 ounces (60 milliliters [1/4 cup]) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
5. Refill the cup with at least 4 ounces (120 milliliters [1/2 cup]) of water or orange juice. Stir vigorously and drink the rinse solution.
6. Dispose of the used syringe.

If you need to carry a filled syringe with you, snap a cap onto the syringe and put the syringe in the carrying case. Use the medication in the syringe within 24 hours.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Sirolimus is usually taken once a day. If you also take cyclosporine, take it at least 4 hours before you take sirolimus.

You may take sirolimus with or without food, but take it the same way every time.

Do not crush, chew, or break a sirolimus tablet. Tell your doctor if you have trouble swallowing the tablet whole.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Sirolimus oral liquid must be mixed only with water or orange juice, no other juices or liquids. Measure the liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Sirolimus can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests. Your dosing schedule may be delayed based on the results of these tests.

You should not stop using sirolimus without your doctor's advice. Stopping suddenly could make your condition worse.

Store sirolimus tablets at room temperature, away from heat, moisture, and light.

Store sirolimus liquid in the refrigerator. Do not freeze. You may notice a slight haze to the liquid. This haze should disappear when the liquid reaches room temperature.

If you are using sirolimus oral liquid with a disposable syringe, you may store a loaded syringe in the carrying case provided. Keep the case at room temperature and use the medicine within 24 hours. Use a disposable syringe only once and then throw it away.

You should not use sirolimus if you are allergic to sirolimus, or if you have ever had a lung transplant or liver transplant.

Talk with your doctor about the risks and benefits of using this medicine. Sirolimus can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Tell your doctor if you have ever had:

• high cholesterol or triglycerides;

• cytomegalovirus (CMV);

• liver disease; or

• a family history of skin cancer (melanoma).

Do not use sirolimus if you are pregnant. Use effective birth control to prevent pregnancy while you are taking sirolimus, and for at least 12 weeks after your last dose.

You should not breast-feed while using this medicine.

Sirolimus should not be given to a child younger than 13 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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). Keep liquid medication in the refrigerator, away from light, closed tightly, and dispose of any unused medication one month after the bottle is opened. Do not freeze. If needed, you may store the bottles for up to 15 days at room temperature.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Avoid drinking grapefruit juice while taking this medication.

Avoid exposure to sunlight or tanning beds. Sirolimus may increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid getting sirolimus oral liquid on your skin. Wash the skin with soap and water if this happens. If sirolimus gets into your eyes, rinse them with plain water.

Grapefruit may interact with sirolimus and lead to unwanted side effects. Avoid the use of grapefruit and grapefruit juice while taking sirolimus.

Do not receive a "live" vaccine while using sirolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Sirolimus may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, or peeling skin; wheezing, difficulty breathing, chest pain or tightness; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Sirolimus may cause serious side effects. Call your doctor at once if you have:

• redness, oozing, or slow healing of a skin wound;

• a new skin lesion, or a mole that has changed in size or color;

• unusual bleeding or bruising;

• sudden chest pain or discomfort, cough, feeling short of breath;

• tenderness around the transplanted kidney;

• signs of infection--fever, chills, painful mouth sores, skin sores, cold or flu symptoms, pain or burning when you urinate; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of sirolimus may include:

• fever, cold symptoms such as stuffy nose, sneezing, sore throat;

• mouth sores;

• nausea, stomach pain, diarrhea;

• headache, muscle aches;

• chest pain;

• dizziness; or

• acne.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can interact with sirolimus, especially:

• bromocriptine (Cycloset, Parlodel);

• cyclosporine;

• danazol;

• St. John's wort;

• tacrolimus;

• cholesterol-lowering medication;

• an antibiotic or antifungal medicine;

• antiviral medicine to treat HIV or hepatitis C;

• heart or blood pressure medication;

• medicine to reduce stomach acid or treat an ulcer; or

• seizure medicine.

This list is not complete and many other drugs may affect sirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.