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RAPAMUNE
SIROLIMUS TABLETS - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

SIROLIMUS TABLETS - ORAL

(sir-oh-LEE-muss)

COMMON BRAND NAME(S): Rapamune

WARNING: This medication may make you more likely to develop an infection or certain types of cancer (e.g., lymphoma, skin cancer). Notify your doctor immediately if you develop any signs of an 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 swelling, or unexplained weight loss. When sirolimus has been used in liver transplants, an infrequent but potentially fatal liver problem has occurred (hepatic artery thrombosis). Use of this medication to prevent rejection of liver transplants is not recommended. Notify your doctor immediately if you develop: dark urine, stomach pain, yellowing eyes or skin, extreme fatigue or nausea. When sirolimus has been used in lung transplants, an infrequent but potentially fatal lung problem has occurred (bronchial anastomotic dehiscence). Use of this medication to prevent rejection of lung transplants is not recommended. Notify your doctor immediately if you develop: difficulty breathing.

Uses

This medication is used to prevent the rejection of transplanted organs (e.g., kidney transplant).

How To Use

Take this medication by mouth usually once daily, exactly as prescribed by your doctor. The dosage is based on your medical condition and response to therapy. This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals (e.g., every 24 hours) and take this drug consistently either with or without food. Other medications (e.g., antibiotics, immunosuppressants) may be prescribed to help prevent infection in your body and to help prevent rejection of the transplanted organ. Take these additional medications exactly as prescribed by your doctor. If you are prescribed cyclosporine along with sirolimus, take this medication four hours after your cyclosporine dose. Consult your pharmacist for more information.

Side Effects

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

Precautions

Tell your doctor your medical history, especially of: liver or kidney problems, high cholesterol or triglyceride levels, any allergies. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol intake because it can intensify the dizziness effects of this medication. This medication may make you more susceptible to 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 promptly if you have unusual lumps, swollen glands, unusual swelling or unexplained weight loss. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received oral polio vaccine. Avoid prolonged sun exposure, tanning booths, or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Women of childbearing potential should use effective birth control methods before starting this drug, during the use of this drug and for 12 weeks after stopping therapy with this drug. Consult your doctor or pharmacist for more information. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is passed into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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), rifamycin antibiotics (e.g., rifampin, rifabutin), macrolide antibiotics (e.g., clarithromycin, erythromycin), aminoglycoside antibiotics (e.g., gentamicin, tobramycin), antifungal drugs (e.g., itraconazole, ketoconazole, amphotericin B), anti-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), herbal products (e.g., St. John's Wort). Do not eat grapefruit or drink grapefruit juice while using this medication unless your doctor instructs you otherwise. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: unusually fast heartbeat.

Notes

Do not share this medication with others. Keep all scheduled medical appointments. Laboratory and medical tests will be performed to monitor your condition and response to therapy.

Missed Dose

If you miss a dose, take 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.

Storage

Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from light and moisture.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).