Sirolimus (By mouth)

Introduction:

Sirolimus (sir-OH-li-mus)

Given after a kidney transplant to keep your body from rejecting the new kidney.

Brand Name(s):

Rapamune

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food. However, you should take it the same way (with or without food) each time.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Use the syringe (plastic needle) that comes with the bottle of the oral liquid medicine to draw the right amount of medicine out of the bottle. Empty the medicine from the syringe into a glass or plastic cup. Mix the medicine with at least 2 ounces (¼ cup) water or orange juice. Drink it right away. Add another 4 ounces (½ cup) of water or orange juice to the cup, swirl or mix it around, and then drink it right away to make sure you have taken all the medicine.
• Throw away the syringe after you have used it.
• The oral liquid medicine may be mixed with water or orange juice only. Do not use apple juice or grapefruit juice.
• If you get any of the oral liquid on your skin, wash the area with soap and water. If you get it in your eyes, rinse them with plain water.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the oral liquid in the refrigerator. Do not freeze. You may leave the medicine out at room temperature for a short while, but keep it away from extreme hot or cold temperatures. If you see a slight haze or cloudiness in the bottle, leave it out at room temperature and shake it until the haze disappears. Then prepare the medicine as usual.
• Store the tablets at room temperature in a closed container, away from heat, moisture, and direct light.
• Keep all medicine away from children and never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take clarithromycin (Biaxin®), erythromycin (Ery-Tab®), itraconazole (Sporanox®), ketoconazole (Nizoral®), rifabutin (Mycobutin®), rifampin (Rimactane®), telithromycin (Ketek®), or voriconazole (Vfend®) while you are being treated with this medicine, unless your doctor tells you to.
• Make sure your doctor knows if you are also using cyclosporine. If you are also taking cyclosporine (Sandimmune® or Neoral®), take it at least 4 hours before taking sirolimus.
• Tell your doctor if you are also using an aminoglycoside medicine (such as gentamicin, tobramycin, or Garamycin®), amphotericin B (Fungizone®), bromocriptine (Parlodel®), carbamazepine (Tegretol®), cimetidine (Tagamet®), cisapride (Propulsid®), clotrimazole (Lotrimin®), danazol (Danocrine®), diltiazem (Dilacor®), fluconazole (Diflucan®), indinavir (Crixivan®), metoclopramide (Reglan®), nicardipine (Cardene®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifapentine (Priftin®), ritonavir (Norvir®), troleandomycin (Tao®), verapamil (Isoptin®), or St. John's wort.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant, and keep using it for at least 12 weeks after you stop taking sirolimus. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of skin cancer, high cholesterol or triglyceride levels in your blood, any type of infection (such as cytomegalovirus infection), liver problems, or lung disease.
• This medicine may increase your chances of getting an infection or of developing certain types of cancer, especially skin cancer or cancer of the lymph system. Avoid people who are sick or have infections.
• This medicine may also increase your risk of bleeding and cause delay in wound healing. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Back or flank pain, or severe stomach pain.
• Blistering, peeling, or red skin rash.
• Changes in how much or how often you urinate, painful urination, or cloudy or bloody urine.
• Chest pain.
• Coughing up blood or mucus (phlegm, snot), or severe shortness of breath.
• Dry mouth, increased thirst or hunger, or muscle cramps.
• Fast or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Lightheadedness, dizziness, or fainting.
• Lumps in your neck, armpits, or groin.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising, pinpoint red spots on skin, or pale skin.
• Unusual weakness or tiredness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Cold sores.
• Diarrhea, constipation, nausea, or vomiting.
• Headache.
• Joint pain.
• Mild skin rash or acne.
• Shakiness or tremors.

If you notice other side effects that you think are caused by this medicine, tell your doctor: