LYCOS RETRIEVER
Prograf: Patients
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Prograf should not be administered concurrently with ciclosporin as the half-life of the latter may be increased. Synergistic/additive nephrotoxic effects can ... occur. Care should be taken when administering Prograf to patients who have previously received ciclosporin and when converting patients from ciclosporin to Prograf-based therapy. It is recommended that ciclosporin blood levels are monitored prior to the administration of Prograf. The most appropriate time to initiate Prograf therapy should be based upon information on ciclosporin blood levels and the clinical condition of the patient. Dosing may be delayed in the presence of elevated ciclosporin levels.
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Insulin-dependent post-transplant diabetes mellitus (PTDM) was reported in 20% of Prograf-treated kidney transplant patients without pretransplant history of diabetes mellitus in the Phase III study (See Tables Below). The median time to onset of PTDM was 68 days. Insulin dependence was reversible in 15% of these PTDM patients at one year and in 50% at two years post transplant. Black and Hispanic kidney transplant patients were at an increased risk of development of PTDM.
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Prograf(R) is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf(R) injection is contraindicated in patients with a hypersensitivity to castor oil. The safety and efficacy of the use of tacrolimus with sirolimus has not been established. For full prescribing information, visit http://www.prograf.com/ or contact Astellas at 1-800-727-7003.
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The use of Prograf in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood levels of tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients (see DOSAGE AND ADMINISTRATION).
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Prograf therapy requires careful monitoring in hospital units equipped and staffed with adequate laboratory and supportive medical resources. The drug should only be prescribed, and changes in immunosuppressive therapy should be initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
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Prograf is the brand name for tacrolimus. You may have ... heard it called FK506. Prograf is an immunosuppressant that is used alone or in combination with other drugs to reduce the symptoms experienced by patients with rheumatoid arthritis.
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