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Generic Name: Sirolimus Tablets (sir-OH-li-mus)
Brand Name: Rapamune

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

Rapamune is used for:

Preventing organ rejection after a kidney transplant. It is used with other medicines. It may also be used for other conditions as determined by your doctor.

Rapamune is an immunosuppressant. It works by inhibiting the effects of the immune system that attack the transplanted organ and cause organ rejection.

Do NOT use Rapamune if:

  • you are allergic to any ingredient in Rapamune
  • you are pregnant
  • you have liver transplant rejection
  • you are taking astemizole, terfenadine, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rapamune :

Some medical conditions may interact with Rapamune . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are of childbearing age, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have high cholesterol, high fat levels in the blood, lung transplant rejection, kidney disease, or decreased blood platelets, or you have recently been vaccinated with a live vaccine

Some MEDICINES MAY INTERACT with Rapamune . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aminoglycosides (eg, gentamicin), amphotericin B, calcineurin inhibitors (eg, tacrolimus), corticosteroids (eg, prednisone), cyclosporine, diltiazem, HIV protease inhibitors (eg, indinavir), imidazoles (eg, ketoconazole), ketolides (eg, telithromycin), macrolides (eg, erythromycin), mibefradil, verapamil, or voriconazole because side effects, such as increased risk of kidney toxicity, may occur
  • Astemizole, hydantoins (eg, phenytoin), or terfenadine because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rapamune may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rapamune :

Use Rapamune as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rapamune may be taken with or without food. Always take it the same way, either always with food or always on an empty stomach.
  • Take Rapamune at the same time each day.
  • If you are also taking cyclosporine, take Rapamune 4 hours after your cyclosporine dose unless otherwise directed by your doctor.
  • Avoid eating grapefruit or drinking grapefruit juice while taking Rapamune .
  • The first dose of this medication should be taken as soon as possible after kidney transplant surgery.
  • If you miss a dose of Rapamune , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rapamune .

Important safety information:

  • This medicine may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rapamune . Using Rapamune alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Rapamune may increase your risk of skin cancer and sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Rapamune . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
  • Check with your doctor before having vaccinations while you are using Rapamune .
  • Do not stop taking Rapamune without first checking with your doctor.
  • Rapamune may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Additional monitoring of your dose or condition may be needed if you are taking quinupristin, dalfopristin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen).
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Rapamune .
  • LAB TESTS, including kidney function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Rapamune with extreme caution in CHILDREN younger than 13 years of age or in high-risk kidney transplant patients younger than 18 years of age. Safety and effectiveness in these age groups have not been confirmed.
  • Use an effective form of (contraceptive) birth control before starting and while taking Rapamune . Continue to use effective birth control for at least 12 weeks after stopping Rapamune .
  • PREGNANCY and BREAST-FEEDING: Rapamune may cause harm to the fetus. Avoid becoming pregnant while taking Rapamune . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Rapamune during pregnancy. It is unknown if Rapamune is excreted in breast milk. Do not breast-feed while taking Rapamune .

Possible side effects of Rapamune :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back pain; chest pain; constipation; diarrhea; dizziness; fever; headache; indigestion; joint pain; nausea; pain; sleeplessness; stomach pain; swelling; tremor; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination; fast, slow, or irregular heartbeat; hoarseness; infection (fever, chills, sore throat); muscle pain; pounding in the chest; severe dizziness; skin lesions; swelling of the face, feet, hands, or abdomen; unusual bleeding or bruising; unusual tiredness; unusual weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Rapamune :

Store this medicine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rapamune out of the reach of children and away from pets.

General information:

  • If you have any questions about Rapamune , please talk with your doctor, pharmacist, or other health care provider.
  • Rapamune is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rapamune . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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