Sirolimus, Oral

What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: sirolimus, oral; Rapamune

What is this medicine used for?

This medicine is taken by mouth to prevent rejection of transplanted kidneys. It is used with cyclosporine (Sandimmune or Neoral) and corticosteroid drugs such as prednisone or cortisone.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• high cholesterol
• liver disease. This medicine should not be taken if you need a liver transplant.

Females of childbearing age: Do not take this medicine if you are pregnant because it may seriously harm the baby. Use an effective method of birth control before, during, and for 12 weeks after treatment with this medicine. Talk to your healthcare provider if you need birth control. Breast-feeding while taking this medicine is not recommended.

How do I take it?

This medicine is available as a tablet or in liquid form. The liquid form may come in a bottle or in individual pouches, depending on which your healthcare provider has prescribed. Follow the instructions on how to withdraw the proper amount of medicine from the package. Your pharmacist can explain how to prepare your medicine.

Take this medicine once a day, starting as soon as possible after the transplant. Take this medicine 4 hours after you take the cyclosporine unless your healthcare provider tells you otherwise. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

You may take this medicine with or without food, as long as you take it the same way each time. Take this medicine with water or diluted in water or orange juice only. Do not take this medicine with grapefruit juice or eat grapefruit while taking this medicine.

If you miss a dose, contact your healthcare provider right away.

What should I watch out for?

You need to have blood tests frequently to see how this medicine is affecting you. Keep all your appointments for tests.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

While taking this medicine there is an increased risk of skin cancer caused by exposure to sunlight or sunlamps. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. Ask your pharmacist for the most protective sunscreen lotion.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Shortness of breath; chest pain; yellow skin and eyes; fast or irregular heartbeat; unusual bruising or bleeding; scaly skin; fever, chills or sore throat; sudden weight gain; frequent urination; burning during urination; blood in the urine.

Other: Diarrhea, constipation, nausea, vomiting, acne, tremors, headache, dizziness, abdominal pain, back pain, muscle pain, swelling of hands or feet, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as clarithromycin (Biaxin), erythromycin (Erythrocin, E.E.S., EryPed, E-Mycin, Ilotycin), telithromycin (Ketek)), gentamicin, tobramycin (Nebcin), amikacin (Amikin), kanamycin (Kantrex), and rifampin (Rifadin, Rimactane)
• antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and fluconazole (Diflucan)
• anticonvulsants such as phenytoin (Dilantin), phenobarbital, fosphenytoin (Cerebyx), and carbamazepine (Tegretol, Atretol, Epitol)
• cholesterol-lowering medicines such as lovastatin (Mevacor), simvastatin (Zocor), atorvastatin (Lipitor), pravastatin (Pravachol), rosuvastatin (Crestor), fluvastatin (Lescol), gemfibrozil (Lopid), and fenofibrate (TriCor)
• cimetidine (Tagamet)
• cyclosporine (Sandimmune, Neoral) (may produce a reaction your healthcare provider wants)
• danazol (Danocrine)
• diltiazem (Cardizem, Dilacor, Diltia, Cartia)
• live virus vaccines
• metoclopramide (Reglan)
• nicardipine (Cardene)
• protease inhibitors such as ritonavir (Norvir), saquinavir (Fortovase, Invirase), indinavir (Crixivan), nelfinavir (Viracept), and amprenavir (Agenerase)
• rifabutin (Mycobutin)
• rifapentine (Priftin).
• St. John's wort
• verapamil (Calan, Isoptin, Covera HS, Verelan).

The effects of this medicine may be increased if you take it with grapefruit juice or eat grapefruit while you are taking it. Discuss this with your healthcare provider.

Many other products may interact with this medicine. Talk with your healthcare provider or pharmacist before you take any other medicine.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. Protect them from heat, moisture, and direct light.

Store the liquid in the refrigerator and away from bright light. Do not allow the liquid to freeze. When refrigerated, this medicine may develop a slight haze that disappears when the medicine reaches room temperature and is gently shaken. This haze is not harmful. If the medicine warms to room temperature, use it within 24 hours.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.