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Sirolimus (By mouth)

Sirolimus (sir-OH-li-mus)

Given after a kidney transplant to keep your body from rejecting the new kidney.

Brand Name(s):

Rapamune

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to sirolimus.

How to Use This Medicine:

Liquid, Tablet

  • Take your medicine as directed.
  • You may take this medicine with or without food. However, you should take it the same way (with or without food) each time.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Swallow the tablet whole. Do not crush, break, or chew it. If you are unable to take the tablet form, your doctor will give you an oral liquid and be given instructions on how to take it.
  • Use the syringe (plastic needle) that comes with the bottle of the oral liquid to draw the right amount of medicine out of the bottle. Empty the medicine from the syringe into a glass or plastic cup. Mix the medicine with at least 2 ounces (¼ cup or 60 mL) water or orange juice. Drink it right away. Add another 4 ounces (½ cup or 120 mL) of water or orange juice to the cup, swirl or mix it around, and then drink it right away to make sure you have taken all the medicine.
  • Throw away the syringe after you have used it.
  • The oral liquid may be mixed with water or orange juice only. Do not use apple juice or grapefruit juice.
  • If you get any of the oral liquid on your skin, wash the area with soap and water. If you get it in your eyes, rinse them with plain water.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the oral liquid in the refrigerator. Do not freeze. You may leave the medicine out at room temperature for a short while, but keep it away from extreme hot or cold temperatures. If you see a slight haze or cloudiness in the bottle, leave it out at room temperature and shake it until the haze disappears. Then prepare the medicine as usual.
  • Store the tablets at room temperature in a closed container, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Do not take clarithromycin (Biaxin®), erythromycin (Ery-Tab®), itraconazole (Sporanox®), ketoconazole (Nizoral®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), telithromycin (Ketek®), or voriconazole (Vfend®) while you are being treated with this medicine, unless your doctor tells you to.
  • Make sure your doctor knows if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®). If you are also taking cyclosporine, take it at least 4 hours before taking sirolimus.
  • Tell your doctor if you are also using an aminoglycoside medicine (such as gentamicin, tobramycin, or Garamycin®), amphotericin B (Fungizone®), bromocriptine (Parlodel®), carbamazepine (Tegretol®), cimetidine (Tagamet®), cisapride (Propulsid®), clotrimazole (Lotrimin®), danazol (Danocrine®), diltiazem (Dilacor®), fluconazole (Diflucan®), indinavir (Crixivan®), metoclopramide (Reglan®), nicardipine (Cardene®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifapentine (Priftin®), ritonavir (Norvir®), troleandomycin (Tao®), verapamil (Isoptin®), or St. John's wort.
  • Make sure your doctor knows if you are using a blood pressure medicine (such as enalapril, lisinopril, Accupril®, Lotrel®, or Zestril®) or medicine to lower cholesterol (such as atorvastatin, Lipitor®, Lopid®, or Zocor®).
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

  • Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant, and keep using it for at least 12 weeks after you stop taking sirolimus. If you think you have become pregnant while using the medicine, tell your doctor right away.
  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have liver disease, lung disease, high cholesterol or fats in the blood, any type of infection, swelling problems (such as ascites, peripheral edema, pleural effusion), or a history of skin cancer.
  • This medicine may increase your chance of getting an infection or of developing certain types of cancer, especially skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you or your child have concerns about this risk.
  • This medicine may cause serious types of allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, lips, or throat while you are using this medicine.
  • This medicine may also increase your risk of bleeding and cause delay in wound healing. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you or your child notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.
  • This medicine may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you or your child are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
  • This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you or your child are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
  • This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Back or flank pain, or severe stomach pain.
  • Blistering, peeling, or red skin rash.
  • Blurred vision, confusion, convulsions, or drowsiness.
  • Changes in how much or how often you urinate, painful urination, or cloudy or bloody urine.
  • Chest pain.
  • Coughing up blood or mucus (phlegm, snot), or severe shortness of breath.
  • Dry mouth, increased thirst or hunger, or muscle cramps.
  • Fast, pounding, or uneven heartbeat.
  • Fever, chills, cough, sore throat, and body aches.
  • Lightheadedness, dizziness, or fainting.
  • Lumps in your neck, armpits, or groin.
  • Rapid weight gain.
  • Swelling in your hands, ankles, or feet.
  • Unusual bleeding or bruising, pinpoint red spots on skin, or pale skin.
  • Unusual weakness or tiredness.
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Cold sores.
  • Diarrhea, constipation, nausea, or vomiting, or mild stomach pain.
  • Gaining weight around your neck, upper back, breast, face, or waist.
  • Headache.
  • Joint pain.
  • Mild skin rash or acne.
  • Shakiness or tremors.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 11/4/2014


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