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|Rapamune Solution

Rapamune Solution

Rapamune Solution 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 Solution 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 Solution if:

• you are allergic to any ingredient in Rapamune Solution
• 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 Solution:

Some medical conditions may interact with Rapamune Solution. 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 Solution. 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 Solution 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 Solution:

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

• Rapamune Solution may be taken with or without food. Always take it the same way, either always with food or always on an empty stomach.
• Rapamune Solution comes with an additional patient leaflet. Read it carefully and reread it each time you get Rapamune Solution refilled.
• Take Rapamune Solution at the same time each day.
• If you are also taking cyclosporine, take Rapamune Solution 4 hours after your cyclosporine dose, unless otherwise directed by your doctor.
• Avoid eating grapefruit or drinking grapefruit juice while taking Rapamune Solution. Do not dilute Rapamune Solution with grapefruit juice.
• The first dose of this medication should be taken as soon as possible after kidney transplant surgery.
• Open the solution by removing the safety cap and squeezing the tab counterclockwise.
• On the first use, insert the adapter (plastic tube with the stopper) tightly into the bottle until it is even with the top of the bottle. Do not remove the adapter from the bottle once it is inserted.
• For each use, tightly insert the syringes with the plunger fully depressed into the opening in the adapter. Withdraw the prescribed amount of medicine by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the appropriate mark on the syringe.
• Always keep the bottle in an upright position. If bubbles form in the syringe, empty the syringe into the bottle and repeat the instructions.
• When carrying the bottled medicine with you, make sure the syringe is tightly closed and placed in a carrying case.
• To take Rapamune Solution, empty the bottle contents in the syringe into a glass or plastic cup containing at least 2 ounces (60 mL) of water or orange juice, stir vigorously for 1 minute, and drink mixture at once. Refill the glass or cup with at least 4 ounces (120 mL) of water or orange juice, stir vigorously again, and drink the contents.
• Only glass or plastic cups should be used to mix Rapamune Solution.
• Clean the mouth of the bottle with a dry cloth before returning it to the refrigerator.
• If you miss a dose of Rapamune Solution, 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 Solution.

Important safety information:

• Rapamune Solution 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 Solution. Using Rapamune Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Rapamune Solution 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 Solution. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
• Avoid getting Rapamune Solution in your eyes, nose, or mouth. If Rapamune Solution gets in your eyes, rinse your eyes with water. If Rapamune Solution gets on your skin, wash the area with soap and water.
• Check with your doctor before having vaccinations while you are using Rapamune Solution.
• When the bottled solution is refrigerated, a slight haze may develop. This will not affect the solution. If the solution becomes hazy, bring it to room temperature and shake it until the haze disappears.
• Rapamune Solution 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 Solution.
• 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 Solution 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 Solution. Continue to use effective birth control for at least 12 weeks after stopping Rapamune Solution.
• PREGNANCY and BREAST-FEEDING: Rapamune Solution may cause harm to the fetus. Avoid becoming pregnant while taking Rapamune Solution. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Rapamune Solution during pregnancy. It is unknown if Rapamune Solution is excreted in breast milk. Do not breast-feed while taking Rapamune Solution.

Possible side effects of Rapamune Solution:

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 in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, the bottles may be stored at room temperatures up to 77 degrees F (25 degrees C) for a short period of time (no more than 15 days). Use bottled contents within 1 month after opening. Rapamune Solution may be kept in the syringe and stored at room temperature or in the refrigerator for a maximum of 24 hours. Use the syringe only once and discard after using. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rapamune Solution out of the reach of children and away from pets.

General information:

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