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Precautions and Warnings With Sirolimus

People who have an infection, a weakened immune system, or liver disease should consult their healthcare provider before taking sirolimus. Other warnings and precautions involve possible complications this drug may cause, such as lung problems or an increased risk for lymphoma. In addition, you may not be able to safely take this medicine if you are using certain other drugs or if you have certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking sirolimus (Rapamune®) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Sirolimus Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • You should only use sirolimus under the direction of a healthcare provider who has experience prescribing medications that suppress the immune system and in treating people who have had an organ transplant.
  • Sirolimus can increase your risk for developing infections, including potentially serious fungal, bacterial, or viral infections. You could become infected with the BK virus, which could cause your new kidney to fail, or with a virus that can cause a serious brain infection known as progressive multifocal leukoencephalopathy (PML). It may also take you longer to get over an infection or for wounds or sores on your body to heal.
  • Contact your healthcare provider right away if you experience signs of an infection, such as:
    • Fever
    • Sore throat
    • Muscle aches or pains
    • Sweats
    • Chills
    • Confusion
    • Sores or wounds that do not heal
    • Confusion or difficulty thinking
    • Loss of strength on one side of the body.
  • Because sirolimus suppresses the immune system, it increases the risk for developing cancers, especially skin cancer and lymphoma (cancer of the lymph nodes). Limit your time in the sun during treatment, and wear sunscreen and protective clothing while outside. Also, contact your healthcare provider if you notice any skin changes or lumps in your neck, underarms, or groin area, as these could be signs of skin cancer or lymphoma.
  • Sirolimus may cause life-threatening side effects, or even death, if used in people who have had a lung or liver transplant. This medicine should not be used to prevent transplant rejection after lung or liver transplantation.
  • Keep all your healthcare provider and laboratory appointments while receiving this medicine. You will need routine monitoring and blood tests to see how you are responding to it. Your healthcare provider will measure your sirolimus blood levels and monitor your kidney function, lipid levels, and urine protein levels.
  • You may develop high blood lipids (high cholesterol and triglycerides) during treatment. If this happens, your healthcare provider may recommend dietary changes and exercise. You also may need to take medicines to reduce your cholesterol level.
  • The use of sirolimus has been associated with serious allergic reactions, including angioedema, which is a potentially dangerous swelling below the surface of the skin. Seek immediate medical attention if you experience any signs of an allergic reaction, such as:
    • Hives
    • Swelling of the face, eyes, lips, or tongue
    • Difficulty breathing
    • Problems swallowing.
  • This medicine has been reported to cause potentially life-threatening lung problems. Contact your healthcare provider if you develop difficulty breathing, shortness of breath, or a new or worsening cough, as these may be signs of lung disease.
  • This medicine is given in combination with cyclosporine (Gengraf®, Neoral®, Sandimmune®) to prevent kidney transplant rejection, at least initially. Using it without cyclosporine may increase the risk for transplant rejection. However, the combination may increase the risk for blood clotting problems. Contact your healthcare provider if you notice:
    • Unusual bruising or bleeding
    • Red spots on the skin
    • Weakness or fatigue
    • Confusion
    • Decrease in urination.
 These could be signs of a serious problem.
  • Your healthcare provider may recommend you take antibiotic or antiviral medicines for as long as a year after your surgery to prevent certain infections. Make sure you know how long you should take the antibiotics, as this is an important part of your treatment.
  • Talk to your healthcare provider before getting any type of vaccination or immunization during sirolimus treatment. Vaccinations may be less effective during this time. People taking this drug should not receive "live" vaccines (see Drug Interactions With Sirolimus).
  • Sirolimus can react with a number of other medications (see Drug Interactions With Sirolimus).
  • This product is considered a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this drug when pregnant (see Rapamune and Pregnancy).
  • It is unknown if sirolimus passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Rapamune and Breastfeeding).

Sirolimus Drug Information

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