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Rapamune

Pronunciation

Generic Name: sirolimus (sih RO lim us)
Brand Name: Rapamune

What is Rapamune (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 given in a combination treatment with cyclosporine and a steroid medicine to prevent your body from rejecting a transplanted kidney.

Sirolimus is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (lim-FAN-gee-oh-LYE-oh-MYE-oh-ma-TOE-sis). This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

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

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

You should not use sirolimus if you have ever had a lung transplant or liver transplant.

Sirolimus can lower blood cells that help fight infection, and may lead to serious conditions including cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Call your doctor right away if you have signs of infection (fever, chills, body aches), a change in your mental state, or problems with vision, speech, or walking.

What should I discuss with my doctor before taking Rapamune (sirolimus)?

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

You should not use this medicine if you are allergic to sirolimus, or if you have ever had a lung transplant or liver transplant.

To make sure sirolimus is safe for you, tell your doctor if you have:

  • high cholesterol or triglycerides;

  • cytomegalovirus (CMV);

  • liver disease; or

  • a family history of skin cancer (melanoma).

It is not known whether this medicine will harm an unborn baby. Do not use sirolimus if you are pregnant. Use effective birth control to prevent pregnancy while you are taking sirolimus, 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. You should not breast-feed while using this medicine.

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

How should I take Rapamune (sirolimus)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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.

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

Sirolimus oral liquid must be mixed in a glass or plastic cup with at least 2 ounces (1/4 cup) of water or orange juice. Do not use any other juices or 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.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Sirolimus can lower blood cells that help fight infection, and may cause you to produce too much of a certain type of white blood cell. This can lead to serious conditions including cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Your blood will need to be tested often. Your kidney function will also need to be tested. Your sirolimus dosing schedule may be delayed based on the results of these tests.

You should not stop using sirolimus without your doctor's advice. Stopping suddenly could make your condition worse.

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

Store sirolimus 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 liquid reaches room temperature.

If you are using sirolimus 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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Rapamune (sirolimus)?

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.

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

Avoid getting sirolimus oral liquid on your skin. Wash the skin with soap and water if this happens. If this medicine gets into your eyes, rinse them with plain water.

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.

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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Rapamune (sirolimus) side effects

Sirolimus may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, or peeling skin; wheezing, difficulty breathing, chest pain or tightness; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain or burning when you urinate;

  • redness, oozing, or slow healing of a skin wound;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • sudden chest pain or discomfort, new or worsening cough, feeling short of breath;

  • general ill feeling, pain or swelling near your transplanted organ;

  • signs of infection--fever, chills, painful mouth sores, skin sores, cold or flu symptoms, night sweats, weight loss;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision; or

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

  • nausea, stomach pain, diarrhea;

  • high blood sugar;

  • headache;

  • joint pain;

  • swelling in your hands or feet;

  • fever; or

  • high blood pressure (severe headache, blurred vision, pounding in your neck or ears).

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.

See also: Side effects (in more detail)

What other drugs will affect Rapamune (sirolimus)?

Many drugs can interact with sirolimus. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • bromocriptine (Cycloset, Parlodel);

  • danazol;

  • St. John's wort;

  • tacrolimus;

  • cholesterol-lowering medication;

  • an antibiotic or antifungal medicine;

  • antiviral medicine to treat HIV or hepatitis C;

  • heart or blood pressure medication;

  • medicine to reduce stomach acid or treat an ulcer; or

  • seizure medicine.

This list is not complete and many other drugs can interact with sirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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.
  • Disclaimer: Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.04. Revision Date: 2015-07-13, 9:54:37 PM.

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