sirolimus

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use an effective form of birth control while you are using this medication and for at least 12 weeks after your treatment ends.

The oral liquid form of sirolimus must be mixed with water or orange juice only. Do not use any other liquids to mix this medicine.

Do not mix this medicine 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.

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

Sirolimus can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines. Contact your doctor immediately if you develop signs of infection.

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

Sirolimus may increase your risk of developing lymphoma, a form of cancer. Talk with your doctor about your specific risk.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Sirolimus may increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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 medicine such as prednisone.

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

Sirolimus may increase your risk of developing lymphoma, a form of cancer. Talk with your doctor about your specific risk.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• high cholesterol or triglycerides;
• cytomegalovirus (CMV);
• liver disease; or
• kidney disease.

If you have any of these conditions, you may not be able to use sirolimus, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using this medication 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 baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medicine should not be given to a child younger than 13 years old.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take the sirolimus tablet with a full glass of water.

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

The oral liquid must be mixed with at least 2 ounces (1/4 cup) of water or orange juice. Do not use any other 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 usually taken once a day. If you also take cyclosporine, wait at least 4 hours after your cyclosporine dose before you take sirolimus.

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

Sirolimus can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

Avoid getting sirolimus liquid on your skin or around your nose. If it does get onto any of these areas, wash with soap and water. If this medicine 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 notice a slight haze to the liquid after it has been refrigerated. This haze will not affect the medication, and should disappear when the medicine reaches room temperature.

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

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a sirolimus overdose are not known.

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

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with sirolimus, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Sirolimus may increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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

Call your doctor at once if you have any of these serious side effects:

• fast heart rate;
• fever, chills, body aches, flu symptoms;
• breathing problems, cough, chest tightness;
• pale skin, easy bruising or bleeding, weakness; or
• pain or burning when you urinate.

Other, less serious side effects may be more likely to occur, such as:

• joint pain;
• nausea, vomiting, diarrhea, constipation, stomach pain;
• headache;
• swelling in your hands or feet, weight gain;
• tremors; or
• acne or skin rash.

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.

Before taking sirolimus, tell your doctor if you are using any of the following drugs:

• amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
• bromocriptine (Parlodel);
• cimetidine (Tagamet);
• cisapride (Propulsid);
• danazol (Danocrine);
• metoclopramide (Reglan );
• rifampin (Rifater, Rifadin, Rimactane), rifabutin (Mycobutin), rifapentin (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 as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, Erythrocin, E.E.S), telithromycin (Ketek), capreomycin (Capastat), or vancomycin (Vancocin, Vancoled);
• antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
• a calcium channel blocker such as diltiazem (Tiazac, Cardizem), nicardipine (Cardene), or verapamil (Calan, Covera, Verelan);
• cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid);
• HIV medicines such as amprenavir (Agenerase), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept); or
• seizure medicine such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal).

If you are using any of these drugs, you may not be able to use sirolimus, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect sirolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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

Sirolimus is available with a prescription under the brand name Rapamune. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Rapamune 1 mg-white, triangular-shaped tablet
• Rapamune 2 mg-yellow, triangular-shaped tablet
• Rapamune 1 mg/mL--2 oz (60 mL) amber bottle