sirolimus

sirolimus

Pronunciation: sih RO lim us

Brand: Rapamune

Rapamune 1 mg

triangular, white, imprinted with RAPAMUNE 1 mg

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Rapamune 2 mg

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

Multum donot

Sirolimus may cause 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 certain 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.

Multum nopreg

Tell your doctor if you become pregnant during treatment. Use effective 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.

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 without your doctor's advice. Contact your doctor immediately if you develop signs of infection.

Multum avoideyes

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 or other forms of cancer. Talk 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 medicine such as prednisone.

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

What should I discuss with my doctor before taking sirolimus?

Sirolimus may increase your risk of developing lymphoma or other forms of cancer. Talk with your doctor about your specific cancer risk.

Multum donot

You should not use this medication if you are allergic to sirolimus.

To make sure you can safely take sirolimus, tell your doctor if you have any of these other conditions:

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

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

Multum nobrfeed

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

Multum nochild

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

How should I take sirolimus?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Multum water

Take the sirolimus tablet with a full glass of water.

Multum nocrush

Do not crush, chew, or break a sirolimus tablet. Tell your doctor if you have trouble swallowing the tablet whole.

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

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.

Sirolimus can lower 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. Your blood may need to be tested often. Visit your doctor regularly.

Multum avoideyes

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.

Multum rt

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

Multum refig

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 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Multum emt

Seek emergency 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 medication guide.

What should I avoid while taking sirolimus?

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 being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Multum donot

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 disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Multum nosun

Avoid exposure to sunlight or tanning beds. Sirolimus may increase 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?

Multum donot

Sirolimus may cause 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 certain 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.

Multum emt

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.

Multum donot

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

  • fast 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, easy bruising or bleeding, weakness;
  • fever, chills, body aches, flu symptoms;
  • night sweats, weight loss;
  • swelling in your face, stomach, hands or feet;
  • rapid weight gain;
  • pain or burning when you urinate; or
  • slow healing of a wound.

Less 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 report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sirolimus?

Tell your doctor about all other 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 medication 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 medicine such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal).

This list is not complete and other drugs may interact with sirolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sirolimus.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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