SIROLIMUS

(sih RO lim us) Brand: Rapamune

What is the most significant information I must know about sirolimus?

• Sirolimus may reason a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving determined medicines. Call your doctor right away if you have any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

• Speak your doctor if you become pregnant during treatment. Use effective birth control while you are using this medicine and for at least 12 weeks after your treatment ends.

• The oral liquid form of sirolimus should be mixed with water or orange juice only. Do not use any another liquids to mix this medication. Do not mix this medication with grapefruit juice or potentially dangerous effects may result. Avoid eating grapefruit or drinking grapefruit juice while you are taking sirolimus.

• If you also take cyclosporine, take the sirolimus at least 4 hours after taking cyclosporine.

• Sirolimus can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or another contagious illnesses. Do not receive any vaccines without your doctor's advice. Contact your doctor immediately if you develop signs of infection.

• Avoid getting this medicine on your skin, or near your nose and mouth. If it does get onto any of these areas, wash with soap and water. If this medication gets into your eyes, rinse them with plain water.

• Sirolimus may magnify your risk of developing lymphoma or another forms of cancer. Conversation with your doctor about your specific cancer risk.

What is sirolimus?

• Sirolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

• Sirolimus is used to prevent your body from rejecting a transplanted kidney. Sirolimus is sometimes used in a combination treatment with cyclosporine (Neoral, Sandimmune) and a steroid medication such as prednisone.

• Sirolimus may also be used for purposes not listed in this medicine guide.

What must I discuss with my doctor till taking sirolimus?

• Sirolimus may magnify your risk of developing lymphoma or another forms of cancer. Conversation with your doctor about your specific cancer risk.

• You must not use this medicine if you are allergic to sirolimus.

• To create certain you can safely take sirolimus, speak your doctor if you have any of these another conditions:

· tall cholesterol or triglycerides;

· cytomegalovirus (CMV);

· liver malady; or

· kidney disease.

• FDA pregnancy category C. It is not known whether sirolimus will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medicine. Use effective birth control while you are using this medicine and for at least 12 weeks after your treatment ends.

• It is not known whether sirolimus passes into breast milk or if it could harm a nursing child. You must not breast-feed while taking sirolimus.

• This medication must not be given to a baby younger than 13 years old.

How must I take sirolimus?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results.

• Take the sirolimus tablet with a full glass of water.

• Do not crush, chew, or interrupt a sirolimus tablet. Speak your doctor if you have trouble swallowing the tablet whole.

• You may take sirolimus with or without food, but take it the same way each time.

• The oral liquid (solution) comes with patient instructions for safety and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

• The oral liquid should be mixed with at least 2 ounces (1/4 cup) of water or orange juice. Do not use any another liquids to mix this medicine.

• Stir the mixture and drink all of it right away. Then add at least 4 ounces (1/2 cup) more water or orange juice to the same glass, stir again and drink right away.

• Sirolimus is generally taken once a day. If you also take cyclosporine, wait at least 4 hours after your cyclosporine doze till you take sirolimus.

• Sirolimus can lower blood cells that help your body fight infections. This can create it easier for you to bleed from an injury or get sick from being near others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

• Avoid getting sirolimus liquid on your skin or near your nose. If it does get onto any of these areas, wash with soap and water. If this medication gets into your eyes, rinse them with plain water.

• Store sirolimus tablets at room temperature, away from heat, moisture, and light.

• Store sirolimus oral liquid in the refrigerator. Do not freeze. You may announcement a slight haze to the liquid after it has been refrigerated. This haze will not affect the medicine, and must disappear when the medication reaches room temperature.

• If you are taking Rapamune oral liquid with a disposable syringe, you may store a loaded syringe in the carrying case provided. Hold the case at room temperature and use the medication within 24 hours. Use a disposable syringe only once and then throw it away.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include some of the serious side effects listed in this medicine guide.

What must I avoid while taking sirolimus?

• Grapefruit and grapefruit juice may interact with sirolimus and could lead to potentially dangerous effects. Do not mix this medication with grapefruit juice. Avoid eating grapefruit or drinking grapefruit juice while you are taking sirolimus.

• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.

• Do not receive a "live" vaccine while using sirolimus. The vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

• Avoid exposure to sunlight or tanning beds. Sirolimus may magnify your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of sirolimus?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· quick heart rate;

· pain when you breathe, feeling short of breath;

· chest pain, feeling weak or tired;

· coughing up blood or mucus;

· feeling like you might pass out;

· pale skin, light bruising or bleeding, weakness;

· fever, chills, body aches, flu symptoms;

· night sweats, weight loss;

· swelling in your person, stomach, hands or feet;

· rapid weight gain;

· pain or burning when you urinate; or

· slow healing of a wound.

• Smaller serious side effects may include:

· joint pain;

· nausea, vomiting, diarrhea, constipation, stomach pain;

· headache; or

· acne or skin rash.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect sirolimus?

• Speak your doctor about all another medicines you use, especially:

· amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

· bromocriptine (Parlodel);

· cimetidine (Tagamet);

· cisapride (Propulsid);

· danazol (Danocrine);

· metoclopramide (Reglan );

· rifampin (Rifater, Rifadin, Rimactane), rifabutin (Mycobutin), rifapentine (Priftin);

· St. John's wort;

· tacrolimus (Prograf);

· an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

· an antibiotic such clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, Erythrocin, E.E.S), telithromycin (Ketek), capreomycin (Capastat), or troleandomycin (Tao);

· an antifungal medicine such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

· a calcium channel blocker such as diltiazem (Tiazac, Cardizem), nicardipine (Cardene), or verapamil (Calan, Covera, Verelan);

· HIV medicines such as indinavir (Crixivan) or ritonavir (Norvir); or

· seizure medication such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal).

• This list is not complete and another drugs may interact with sirolimus. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about sirolimus.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

(41)