Pronunciation: sih RO lim us
0.5 mg, triangular, tan, imprinted with RAPAMUNE 0.5 mg
1 mg, triangular, white, imprinted with RAPAMUNE 1 mg
2 mg, triangular, beige, imprinted with RAPAMUNE 2 mg
1 mg, triangular, white, imprinted with RAPAMUNE 1 mg
1 mg, triangular, white, imprinted with RD 53
2 mg, triangular, yellow, imprinted with RD 54
What is the most important information I should know about sirolimus?
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.
What is sirolimus?
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.
What should I discuss with my healthcare provider before taking sirolimus?
You should not use this medicine 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.
How should I take sirolimus?
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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking sirolimus?
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 this medicine 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).
What are the possible side effects of sirolimus?
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.
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 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
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.
What other drugs will affect sirolimus?
Tell your doctor about all your current medicines. Many drugs can interact with sirolimus, especially:
- bromocriptine (Cycloset, Parlodel);
- St. John's wort;
- 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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