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|Sirolimus

Sirolimus

Sirolimus 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.

Sirolimus 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 Sirolimus if:

• you are allergic to any ingredient in Sirolimus
• 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 Sirolimus :

Some medical conditions may interact with Sirolimus . 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 Sirolimus . 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 Sirolimus 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 Sirolimus :

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

• Sirolimus may be taken with or without food. Always take it the same way, either always with food or always on an empty stomach.
• Take Sirolimus at the same time each day.
• If you are also taking cyclosporine, take Sirolimus 4 hours after your cyclosporine dose unless otherwise directed by your doctor.
• Avoid eating grapefruit or drinking grapefruit juice while taking Sirolimus .
• The first dose of this medication should be taken as soon as possible after kidney transplant surgery.
• If you miss a dose of Sirolimus , 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 Sirolimus .

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 Sirolimus . Using Sirolimus alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Sirolimus 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 Sirolimus . 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 Sirolimus .
• Do not stop taking Sirolimus without first checking with your doctor.
• Sirolimus 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 Sirolimus .
• 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 Sirolimus 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 Sirolimus . Continue to use effective birth control for at least 12 weeks after stopping Sirolimus .
• PREGNANCY and BREAST-FEEDING: Sirolimus may cause harm to the fetus. Avoid becoming pregnant while taking Sirolimus . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Sirolimus during pregnancy. It is unknown if Sirolimus is excreted in breast milk. Do not breast-feed while taking Sirolimus .

Possible side effects of Sirolimus :

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.

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.

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 Sirolimus out of the reach of children and away from pets.

General information:

• If you have any questions about Sirolimus , please talk with your doctor, pharmacist, or other health care provider.
• Sirolimus 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 Sirolimus . 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.