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.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given around-the-clock until you are ready to take the pill form of tacrolimus.
The tacrolimus capsule is usually taken every 12 hours. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
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.
Store tacrolimus at room temperature away from moisture and heat.Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.
Do not consume grapefruit or grapefruit juice during treatment with tacrolimus unless your doctor has told you do. Tacrolimus can have a dangerous interaction with grapefruit or grapefruit juice. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tacrolimus may increase the risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.Do not receive a "live" vaccine while you are being treated with tacrolimus. Vaccines may not work as well during your treatment with tacrolimus.
pain in the lower back or side;
urinating less than usual or not at all;
painful urination, blood in your urine;
problems with your vision, speech, or coordination;
tremor (shaking), headache, confusion, numbness or tingly feeling;
pale skin, easy bruising or bleeding, unusual weakness;
fever, chills, body aches, flu symptoms;
muscle weakness, tiredness, fast or pounding heartbeat, mild shortness of breath; or
increased urination, thirst, or hunger.
Less serious side effects may include:
swelling in your hands or feet;
nausea, vomiting, diarrhea, constipation, loss of appetite;
sleep problems (insomnia); or
itching skin or mild rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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