RAPAMUNE

Drug Name: RAPAMUNE

RAPAMUNE DESCRIPTION:
SIROLIMUS - ORAL (sir-oh-LEE-muss)

COMMON RAPAMUNE BRAND NAME(S):
Rapamune

RAPAMUNE SIDE EFFECTS:
Nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if you have any of these serious side effects: signs of infection such as fever or persistent sore throat, unexplained weight loss, unusual lumps or swollen glands, severe headache, unusual tiredness or weakness, unusual bleeding or bruising, muscle/joint/back pain, unusually fast/slow/irregular pulse, swelling, dizziness, rash. Tell your doctor immediately if you have any of these highly unlikely but very serious side effects: a change in the amount of urine. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE RAPAMUNE:
RAPAMUNE: Take RAPAMUNE by mouth once daily, exactly as prescribed by your doctor. The dosage depends on your condition and response to therapy. Learn all preparation and usage instructions in the product package. Ask your doctor or pharmacist if you have questions about any of the information. Mix the prescribed dose of RAPAMUNE with at least two ounces (1/4 cup, 60 ml) of water or orange juice in a plastic or glass container. Stir vigorously and drink immediately. Refill the container with at least four more ounces (1/2 cup, 120 ml) of water or orange juice, stir vigorously and drink immediately. Do not use grapefruit juice to dilute RAPAMUNE. Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise. RAPAMUNE works best when the amount of medicine in your body is kept at a constant level. Therefore, take RAPAMUNE at evenly spaced intervals (e.g., every 24 hours) and take RAPAMUNE consistently with or without food. Other medications (e.g., antibiotics, other immunosuppressants such as cyclosporine) may be prescribed to prevent infections, and prevent rejection of the transplanted organ. Take these medications exactly as prescribed by your doctor. If you use certain brands/types of cyclosporine (e.g., Neoral, SangCya), take sirolimus four hours after your dose of cyclosporine. Consult your pharmacist for more information. If a syringe is used to measure the prescribed dose, use a new syringe for each dose. Discard used syringes safely and properly.

RAPAMUNE WARNING:
RAPAMUNE may make you more likely to develop an infection or certain types of cancer (e.g., lymphoma). Notify your doctor immediately if you develop any signs of infection such as fever, chills, sore throat, white patches in your mouth or a change in vaginal discharge. Also notify your doctor immediately if you have unusual lumps, swollen glands, unusual sweating or unexplained weight loss.

RAPAMUNE USES:
RAPAMUNE is used to prevent the rejection of transplanted organs (e.g., kidney).

RAPAMUNE PRECAUTIONS:
Tell your doctor your medical history, including any allergies, liver problems; or high blood levels of cholesterol or triglycerides. RAPAMUNE may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received oral polio vaccine. Women of childbearing age should use effective birth control methods before starting RAPAMUNE, during the use of RAPAMUNE and for 12 weeks after stopping therapy with RAPAMUNE. Consult your doctor or pharmacist for more information. RAPAMUNE should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether RAPAMUNE is passed into breast milk. Because of the potential risk to the infant, breast-feeding while using RAPAMUNE is not recommended. Consult your doctor before breast-feeding.

RAPAMUNE DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription medication you may use, especially drugs for high cholesterol or triglycerides (e.g., lovastatin, atorvastatin, gemfibrozil); calcium-channel blockers (e.g., diltiazem, verapamil, nicardipine); rifamycins (e.g., rifampin, rifabutin); macrolide antibiotics (e.g., clarithromycin, erythromycin); aminoglycoside antibiotics (e.g., gentamicin, tobramycin); antifungal drugs (e.g., ketoconazole, fluconazole, amphotericin B); seizure medications (e.g., phenytoin, phenobarbital, carbamazepine); stomach or ulcer medications (e.g., metoclopramide, cisapride, cimetidine); bromocriptine, danazol or HIV-protease inhibitors (e.g., ritonavir, indinavir). Do not start or stop any medicine without doctor or pharmacist approval.

RAPAMUNE OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately.

RAPAMUNE NOTES:
Do not share RAPAMUNE with others. Keep all scheduled medical appointments. Laboratory and medical tests will be performed to monitor your progress.

MISSED RAPAMUNE DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

RAPAMUNE STORAGE:
Store at refrigerator temperature between 36 and 46 degrees F (2 to 8 degrees C) away from light and moisture. Once opened, bottles containing RAPAMUNE should be used within 30 days. When refrigerated, this product may develop a slight haze. If this haze occurs, allow the drug to stand at room temperature and shake gently until the haze disappears. The haze does not affect the quality of the drug. Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert(TM) at 1-800-854-1166. In Canada call 1-800-668-1507.