Rapamune - Talk Medical

Generic Name: sirolimus

Brands: Rapamune

What is the most important information I should know about Rapamune?

· Do not consume grapefruit or grapefruit juice during treatment with Rapamune unless your doctor specifically directs otherwise. Rapamune can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects.

· Increased susceptibility to infection and the possible development of lymphoma (cancer of the immune system) and other forms of cancer may result from the use of an immunosuppressant such as Rapamune. Discuss these risks with your doctor and avoid sources of infection.

· Notify your doctor immediately if you develop a cough, sore throat, fever, chills, or swelling of glands. These symptoms could be early signs of an infection.

· Tell your doctor and dentist that you are taking this medication before having surgery, starting any other medicines, or receiving any vaccinations.

What is Rapamune?

· Rapamune is an immunosuppressant. Immunosuppressants decrease the effects of the body's immune system.

· Rapamune is used to prevent your body from rejecting a transplanted kidney. It is usually combined with a steroid medication (e.g., prednisone) and cyclosporine (Neoral, Sandimmune).

· Rapamune may also be used for purposes other than those listed in this medication guide.

Who should not take Rapamune?

· Before taking Rapamune, tell your doctor if you have ·liver disease; ·a viral, bacterial, or fungal infection; ·high blood cholesterol or triglycerides; or ·any other serious or chronic medical condition.

· You may not be able to take Rapamune, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

· Rapamune is in the FDA pregnancy category C. This means that it is not known whether Rapamune will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. For women who could become pregnant, effective contraception is recommended before the start of treatment with Rapamune, during treatment with Rapamune, and for 12 weeks after Rapamune therapy has been stopped.

· It is not known whether Rapamune passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

· Rapamune is not approved for use by children younger than 13 years of age.

How should I take Rapamune?

· Take Rapamune exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

· Take the oral tablets with a full glass of water.

· To use the oral solution from a bottle: ·Upon first use, open the solution bottle and insert the adapter assembly (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle. Do not remove the adapter assembly from the bottle once inserted. For each use, fully depress the plunger of one of the amber syringes, then insert it tightly into the opening of the adaptor. ·Withdraw the prescribed amount of Rapamune solution 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 procedure. If it is necessary to carry a filled syringe, place a cap securely on the syringe (the cap should snap into place) then place the capped syringe into the enclosed carrying case. Rapamune solution can be kept in the syringe for a maximum of 24 hours at room temperature up to 25 degrees Celsius (77 degrees Fahrenheit) or refrigerated between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit). ·Empty the prescribed amount of Rapamune from the syringe into only a glass or plastic container holding at least 2 ounces (one-quarter cup, 60 mL) of water or orange juice. No other liquids should be used to dilute the solution. Stir vigorously for one minute and drink at once. Refill the container with at least 4 ounces (one-half cup, 120 mL) more of water or orange juice, stir vigorously, and drink at once. Discard each syringe and cap after one use. ·If it is necessary to wipe clean the mouth of the bottle before returning the product to the refrigerator, wipe with a dry cloth to avoid introducing water, or any other liquid, into the bottle. ·The Rapamune solution may develop a slight haze when refrigerated. If this occurs, allow the solution to stand at room temperature and shake gently until the haze disappears. The presence of this haze does not affect the quality of the product.

· To use the oral solution from the pouches: ·Before opening a pouch, squeeze the pouch from the neck area to push the contents into the lower part of the pouch. Fold the pouch along the marked line, then use scissors to cut along the marked line. ·Squeeze the entire contents of the pouch, into only a glass or plastic container holding at least 2 ounces (one-quarter cup, 60 mL) of water or orange juice. No other liquids should be used to dilute the solution. Stir vigorously for one minute and drink at once. Refill the container with at least 4 ounces (one-half cup, 120 mL) more of water or orange juice, stir vigorously, and drink at once.

· Rapamune is usually taken once a day. It is recommended that Rapamune be taken 4 hours after taking cyclosporine (Neoral, Sandimmune). Follow your doctor's instructions

· Rapamune can be taken either with or without food, but it is very important to take every dose of Rapamune in the same relation to food. For example, if you take Rapamune with food, you should take every dose with food. If you take Rapamune on an empty stomach, you should take every dose on an empty stomach.

· Your doctor may want you to have regularly scheduled blood tests while taking Rapamune.

· If Rapamune comes into direct contact with skin or mucous membranes, wash thoroughly with soap and water. If Rapamune comes into contact with the eyes, rinse the eyes with plain water.

· Store Rapamune oral tablets at room temperature. Store Rapamune bottles or pouches of oral solution in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit). Once a bottle is opened, use the contents within one month. If necessary, the pouches and bottles can be stored at room temperature up to 25 degrees Celsius (77 degrees Fahrenheit) for several days, but not longer than 30 days.

What happens if I miss a dose?

· Notify your doctor if you miss a dose of this medication.

What happens if I overdose?

· Seek emergency medical attention.

· Symptoms of a Rapamune overdose are not known.

What should I avoid while taking Rapamune?

· Increased susceptibility to infection and the possible development of lymphoma (cancer of the immune system) and other types of cancer may result from the use of an immunosuppressant such as Rapamune. Discuss these risks with your doctor and avoid sources of infection.

· Tell your doctor and dentist that you are taking this medication before having surgery, starting any other medicines, or receiving any vaccinations.

· Rapamune may increase the risk of skin cancer. Avoid prolonged exposure to sunlight or UV light and wear protective clothing and use a sunscreen with a high sun protection factor (SPF) when sun exposure is unavoidable.

What are the possible side effects of Rapamune?

· If you experience any of the following serious side effects, stop taking Rapamune and seek emergency medical attention or contact your doctor immediately: ·an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or ·cough, sore throat, fever, chills, or swelling of glands.

· Increased susceptibility to infection and the possible development of lymphoma (cancer of the immune system) or other types of cancer may result from the use of Rapamune.

· Other, less serious side effects may also occur. Continue to take Rapamune and notify your doctor if you experience ·upset stomach, abdominal pain, nausea, or vomiting; ·diarrhea or constipation; ·headache; ·increased blood pressure; ·increased cholesterol or triglyceride levels; ·water retention or swelling; ·insomnia; ·tremor; ·sore or weak muscles or joints; ·a rash; ·upper respiratory or urinary tract infections; or ·acne.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Rapamune?

· Do not take Rapamune without first talking to your doctor if you are taking any other medicines, especially any of the following: ·a seizure medicine including carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin); ·an antifungal medicine including ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan); ·a calcium channel blocker (heart medicine) including verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), or nicardipine (Cardene); ·erythromycin (Ery-Tab, E-Mycin, E.E.S., others), clarithromycin (Biaxin), or troleandomycin (TAO); ·an HIV-protease inhibitor including ritonavir (Norvir), indinavir (Crixivan), and others; ·bromocriptine (Parlodel); ·cimetidine (Tagamet, Tagamet HB); ·cisapride (Propulsid); ·danazol (Danocrine); ·metoclopramide (Reglan); ·rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), or rifapentine (Priftin); or ·any type of vaccination.

· You may not be able to take Rapamune, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

· Drugs other than those listed here may also interact with Rapamune. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

· Your pharmacist has additional information about Rapamune written for health professionals that you may read.

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