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SIROLIMUS (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Rapamune

In Canada—

  • Rapamune

Another commonly used name is Rapamycin .


  • Immunosuppressant


Sirolimus (sir-OH-li-mus) belongs to a group of medicines known as immunosuppressive agents. It is used to lower the body"s natural immunity in patients who receive kidney transplants.

When a patient receives an organ transplant, the body"s white blood cells will try to get rid of (reject) the transplanted organ. Sirolimus works by preventing the white blood cells from getting rid of the transplanted organ.

Sirolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also reduce the body"s ability to fight infections. You and your doctor should talk about the good this medicine will do as well as the risks of using it.

Sirolimus is available only with your doctor"s prescription, in the following dosage forms:

  • Oral
  • Oral solution (U.S. and Canada)
  • Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sirolimus, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sirolimus. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sirolimus has not been studied in pregnant women. However, studies in animals have shown that sirolimus causes problems in the fetus. It is very important that an effective form of birth control be used before starting sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has stopped.

Breast-feeding—It is not known whether sirolimus passes into human breast milk. However, because this medicine may cause serious side effects, breast-feeding may not be recommended while you are receiving it. Discuss with your doctor whether or not you should breast-feed while you are receiving sirolimus.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sirolimus, it is especially important that your health care professional knows if you are taking any of the following:

  • Clarithromycin (e.g., Biaxin) or
  • Cyclosporine (e.g. Neoral or Sandimmune) or
  • Diltiazem (e.g., Cardizem) or
  • Erythromycin (e.g., Akne-Mycin, Ery-Tab) or
  • Itraconazole (e.g., Sporanox) or
  • Ketoconazole (e.g., Nizoral)
  • Telithromycin (e.g., Ketek) or
  • Verapamil (e.g., Calan SR, Isoptin, Verelan) or
  • Voriconazole (e.g., VFEND)—May increase the effects of sirolimus by increasing the amount of this medicine in the body
  • Carbamazepine (e.g., Tegretol) or
  • Rifabutin (e.g., Mycobutin) or
  • Rifampin (e.g., Rifadin) or
  • Rifapentine (e.g., Priftin)
  • St. John"s wort—May decrease the effects of sirolimus by decreasing the amount of sirolimus in the body
  • Tacrolimus (e.g. Prograf)—May cause liver transplant rejection or serious side effects in patients on sirolimus

Other medical problems—The presence of other medical problems may affect the use of sirolimus. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cancer or
  • Hyperlipidemia (high amount of cholesterol and fats in the blood)—Sirolimus can make these conditions worse
  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
  • Infection—Sirolimus decreases the body"s ability to fight infection
  • Liver disease—A lower dose of sirolimus may be needed in patients with this condition
  • Liver transplantation or
  • Lung transplantation—Sirolimus is not recommended in liver or lung transplant patients

Proper Use of This Medicine

This medicine usually comes with patient information or directions. Read them carefully and make sure you understand them before taking this medicine. If you have any questions, ask your health care professional.

Take this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may lead to rejection of your transplanted kidney.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. This will help sirolimus work better by keeping a constant amount in the blood.

Absorption of this medicine may be changed if you change your diet. This medicine should be taken consistently with respect to meals. You should not change the type or amount of food you eat unless you discuss it with your health care professional.

Do not stop taking this medicine without first checking with your doctor. You may have to take this medicine for the rest of your life to prevent your body from rejecting the transplant.

Sirolimus usually is used along with a corticosteroid (cortisone-like medicine) and cyclosporine (another immunosuppressive agent). Sirolimus should be taken 4 hours after cyclosporine modified oral solution (Neoral ) or cyclosporine modified capsules (Neoral ). If you have any questions about this, ask your health care professional.

Mix sirolimus oral solution with at least 2 ounces (1/4 cup, 60 milliliters [mL]) of water or orange juice in a glass or plastic container. Stir the mixture well and drink it immediately. Then, rinse the container with at least 4 ounces (1/2 cup, 120 mL) of additional water or orange juice, stir it well, and drink it to make sure that all of the medicine is taken.

Check with your doctor before you stop using cyclosporine when you have been taking sirolimus together with cyclosporine for 4 months after your transplant. Your doctor will tell you if you need to keep taking cyclosporine.

Dosing—The dose of sirolimus will be different for different patients. Follow your doctor"s orders or the directions on the label. The following information includes only the average doses of sirolimus. If your dose is different, do not change it unless your doctor tells you to do so. If you have any questions about the proper dose of sirolimus, ask your doctor.

  • For oral dosage form (oral solution or tablets):
    • Adults and children 13 years of age and older weighing 88 pounds (40 kilograms) or more: The usual dose is 2 milligrams (mg) a day after an initial one-time dose of 6 mg.
    • For children 13 years of age and older who weigh less than 88 pounds (40 kilograms): The dose is based on body size. It is usually 1 mg per square meter of body surface area once a day after an initial one-time dose of 3 mg per square meter of body surface area.
    • For children up to 13 years of age: Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of sirolimus and remember it within 12 hours, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose, go back to your regular dosing schedule, and check with your doctor. Do not double doses.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Store the oral liquid form in the refrigerator.
  • Store tablets at room temperature.
  • Protect from exposure to light.
  • Keep the medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are taking sirolimus, it is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.

Raw oysters or other shellfish may contain bacteria that can cause serious illness and possibly death. This is more likely to be a problem if these foods are eaten by patients with certain medical conditions. Even eating oysters from “clean” water or good restaurants does not guarantee that the oysters do not contain the bacteria. Eating raw shellfish is not a problem for most healthy people; however, patients with the following conditions may be at greater risk: cancer, immune disorders, organ transplantation, long-term corticosteroid use (as for asthma, arthritis, or organ transplantation), liver disease (including viral hepatitis), excess alcohol intake (2 to 3 drinks or more per day), diabetes, stomach problems (including stomach surgery and low stomach acid), and hemochromatosis (an iron disorder). Do not eat raw oysters or other shellfish while you are taking sirolimus. Be sure oysters and shellfish are fully cooked.

While you are being treated with sirolimus, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations without your doctor"s approval. Sirolimus may lower your body"s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken the oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Treatment with sirolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

Grapefruits and grapefruit juice may increase the effects of sirolimus by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.

Sirolimus may cause you to have a greater risk for getting skin cancer. When you begin taking this medicine:

  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses
  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips
  • Do not use a sunlamp or tanning bed or booth.
Check with your doctor right away if you notice a new mole; a change in size, shape or color of an existing mole; or a mole that leaks fluid or bleeds.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way sirolimus acts on the body, there is a chance that it may cause effects that may not occur until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphoma.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black or red, tarry stools; chest pain; general feeling of discomfort or illness; shortness of breath; swollen glands; weight loss, unusual; yellow skin and eyes

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Abdominal cramps or pain; accumulation of pus; anxiousness, unexplained; backache; bleeding from gums or nose; blindness; bloody or cloudy urine; blue lips and fingernails; blurred vision; body aches or pain; bone pain; bruising; burning while urinating; burning, dry, or itching eyes; burning or stinging of skin; burning, tingling, numbness, or pain in the hands, arms, feet, or legs; change in mental status; changes in skin color; chills; cold hands and feet; cold sweats; confusion; convulsions (seizures); cough; cough producing mucus; cough that sometimes produces a pink frothy sputum; coughing up blood; dark or bloody urine; deafness; decreased urge to urinate; decreased urine output; decreased vision; difficult, fast, noisy breathing sometimes with wheezing; difficulty in breathing or swallowing; difficulty speaking; dilated neck veins; discharge from eye; dizziness; drowsiness; dry mouth; ear congestion; earache; excessive tearing; extreme fatigue; eye pain; facial hair growth in females; fainting; faintness or lightheadedness when getting up from lying or sitting position; fast, slow, or irregular heartbeat; fatigue; feeling faint; feeling of warmth or heat; fever; flushed, dry skin; flushing or redness of skin, especially on face and neck; fractures; frequent urge to urinate; fruit-like breath odor; full or round face, neck, or trunk; increased menstrual flow or vaginal bleeding; increased hunger; increased sweating; increased thirst; increased urination; irregular breathing; irritability; itching, pain, redness, swelling, tenderness, warmth on skin; lab results that show problems with liver; large, flat, blue or purplish patches in the skin; lightheadedness; lack or loss of appetite; loss of consciousness; loss of sexual ability, desire, drive, or performance; loss of voice; lower back or side pain; lower back or side pain; lump in abdomen; menstrual irregularities; mood changes; muscle cramps in hands, arms, feet, legs, or face; muscle pain; muscle wasting; nasal congestion; nausea or vomiting; noisy breathing; numbness or tingling around lips, hands, or feet; pain in chest, groin, or legs, especially the calves; pain, tenderness, swelling of foot or leg; painful blisters on trunk of body; painful cold sores or blisters on lips, nose, eyes, or genitals; painful or difficult urination; pale skin; paralysis; pinpoint red spots on skin; pounding or racing heartbeat or pulse; prolonged bleeding from cuts; pus in urine; rapid heartbeat; rapid, shallow breathing; rash; red or dark brown urine; redness or swelling in ear; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; ringing in the ears; runny nose; sensation of pins and needles; severe constipation; severe vomiting; severe, sudden headache; slurred speech; sneezing; sore mouth or tongue; sore throat; sores or white spots on lips or in mouth; stabbing pain; stomach pain or upset; stomachache; sudden decrease in amount of urine; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; sudden, unexplained shortness of breath; sweating; swelling of face, fingers, hands, ankles, feet, or lower legs; swollen glands; swollen, painful or tender lymph glands in neck, armpit, or groin; swollen, red, tender area of infection; tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area; tightness in chest; tiredness; tremor; trouble breathing; ulcers on lips or in mouth; unusual bleeding or bruising; unusual tiredness or weakness; vision changes; weakness; weakness or heaviness of legs; weight gain; wheezing; white patches in mouth and/or on tongue

Less common

Bloating; change is size, shape or color of existing mole; darkened urine; hoarseness; mole that leaks fluid or bleeds; new mole; pains in stomach, side or abdomen, possibly radiating to the back; skin ulcer or sores


Weight gain, unusual

Unknown frequency

Abnormal wound healing; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Abdomen enlarged; abnormal vision; acne; belching; blistering, crusting, irritation, itching, or reddening of skin; bloated full feeling; burning feeling in chest or stomach; burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feeling; constipation; continuing ring or buzzing or other unexplained noise in ears; cracked, dry, scaly skin; crying; decrease in frequency of urination; decrease in height; decreased interest in sexual intercourse; degenerative disease of the joint; depersonalization; diarrhea; difficulty in moving; difficulty in passing urine [dribbling]; discouragement; dysphoria; ear pain; euphoria; excess air or gas in stomach or intestines; excessive muscle tone, muscle tension or tightness; fear; feeling sad or empty; headache; hearing loss; heartburn; inability to have or keep an erection; increase in heart rate; increased hair growth, especially on the face; increased urge to urinate during the night; indigestion; irritation in mouth; itching skin; joint pain or swelling; kidney pain; leg cramps; loss of bladder control; loss of energy or weakness; loss of interest or pleasure; loss of strength or energy; lower abdominal pain; mental depression; muscle aches, pain, stiffness, or weakness; nervousness; pain; pain in back, ribs, arms, or legs; pain or burning in throat; pain or tenderness around eyes and cheekbones; paranoia; passing gas; pelvic pain; quick to react or overreact emotionally; rapid breathing; rapidly changing moods; inflammation, redness, or swelling of gums or mouth; shaking or trembling; shivering; sleepiness; sunken eyes; swelling; swelling of the scrotum; tender, or enlarged gums; tenderness in stomach area; thickening of the skin; trouble concentrating; trouble in sleeping; waking to urinate at night; wrinkled skin

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/20/2000
Revised: 09/03/2004

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