Special Alerts:
[Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and mycophenolate (CellCept) to sirolimus (Rapamune) and mycophenolate at 12 weeks post heart transplantation. The safety and efficacy of mycophenolate in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept and http://www.fda.gov/medwatch/safety/2007/cellcept_DHCPletter_02-01-2007.pdf.
Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.Tacrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.
Some people receiving tacrolimus after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.
Tacrolimus 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.
Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
Tacrolimus may also be used for other purposes not listed in this medication guide.
Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.
Do not take tacrolimus if you are also using cyclosporine (Neoral, Sandimmune, Gengraf).Before taking tacrolimus, tell your doctor if you have:
an allergy to castor oil;
If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.
Some people receiving tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes if you have concerns.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tacrolimus can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.Related Learning Centers |
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