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Important Safety Information
There is an increased risk of developing infections or certain cancers, especially
lymphoma and skin cancers. Rapamune has not been shown to be safe and effective
in people who have had liver or lung transplants. Serious complications and death
may happen in people who take Rapamune after a liver or lung transplant. You should
not take Rapamune if you have had a liver or lung transplant without talking with
your doctor.
Do not take Rapamune if you know you are allergic to sirolimus or any of the other
ingredients in Rapamune. Symptoms of an allergic reaction include swelling of your
face, eyes, or mouth; trouble breathing or wheezing; throat tightness; chest pain
or tightness; feeling dizzy or faint; and rash or peeling of your skin.
Before taking Rapamune, tell your doctor if you have liver problems, skin cancer
or it runs in your family, high cholesterol or triglycerides, are breastfeeding
or plan to breastfeed, and are pregnant or plan to become pregnant. Women of childbearing
potential should use effective birth control before therapy, during therapy, and
for 12 weeks after Rapamune therapy has been stopped. Rapamune may interact with
other medicines. Make sure that your doctor is aware of all prescription and over-the-counter
drugs that you are taking, including vitamins, herbs, and nutritional supplements.
Rapamune may cause swelling in your hands, feet, and in various tissues of your
body. Call your doctor if you have trouble breathing.
Rapamune may cause your wounds to heal slowly or not heal well resulting in redness,
drainage, or opening of the wound.
Rapamune may increase the levels of cholesterol and triglycerides (lipids or fat)
in your blood. Your doctor should do blood tests to check your lipids during treatment
with Rapamune. Your doctor may recommend treatment if your lipid levels become too
high. Your lipid levels may remain high even if you follow your prescribed treatment
plan.
In patients taking Rapamune with cyclosporine, decreased kidney function has been
observed. Your doctor will regularly check your kidney function.
Rapamune may increase protein in your urine. Your doctor may monitor you for abnormal
protein in your urine from time to time.
Rapamune may increase your risk for viral infections. Certain viruses can live in
your body and cause active infections when your immune system is weak. One of these
viruses, BK virus, can affect how your kidney works and cause your transplanted
kidney to fail. A certain virus can cause a rare serious brain infection called
Progressive Multifocal Leukoencephalopathy causing death or severe disability.
Rapamune may cause potentially life-threatening lung or breathing problems. Symptoms
may include coughing, shortness of breath, or difficulty breathing.
When Rapamune is taken with cyclosporine or tacrolimus, you may develop a blood
clotting problem resulting in unexplained bleeding or bruising.
Common side effects associated with Rapamune include high blood pressure, pain (including
stomach and joint pain), diarrhea, headache, fever, urinary tract infection, low
red blood cell count (anemia), nausea, and low platelet count (cells that help blood
to clot). If you experience any side effects, contact your doctor.
Indications and Usage
RAPAMUNE® (sirolimus)
is indicated for the prevention of organ rejection in kidney transplant patients
aged 13 years or older. Blood levels of sirolimus should be checked in all patients
taking Rapamune.
In patients at low to moderate risk of acute rejection, it is
recommended that Rapamune be used initially in combination with cyclosporine and
corticosteroids; cyclosporine should be withdrawn approximately 3 months after transplantation.
Cyclosporine withdrawal has not been studied in patients who have had severe acute
rejection prior to cyclosporine withdrawal, those who require dialysis or have a
high serum creatinine, Black patients, patients receiving a repeat kidney transplant,
patients receiving other transplanted organs besides the kidney transplant, or patients
with antibodies that may be directed against the kidney transplant.
In patients at high risk of acute rejection (defined as Black patients
and/or patients receiving a repeat kidney transplant who lost a previous kidney
transplant from rejection and/or patients with high levels of antibodies that may
be directed against the kidney transplant), it is recommended that Rapamune be used
in combination with cyclosporine and corticosteroids for the first year following
transplantation. The safety and efficacy of this combination in high-risk patients
have not been studied beyond one year; therefore, after the first year, adjustments
to the immunosuppressive regimen may be considered by your doctor.
In pediatric patients, the safety and efficacy of Rapamune have
not been established in kidney transplant patients less than 13 years old, or in
patients less than 18 years old who are considered at high risk of acute rejection.
The safety and efficacy of Rapamune without cyclosporine in newly transplanted kidney
patients have not been established.
The safety and efficacy of changing from either cyclosporine or tacrolimus to Rapamune
in maintenance kidney transplant patients have not been established.
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