PROGRAF(tacrolimus) capsules, USP, PROGRAF(tacrolimus) injection, (for intravenous use)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF - ® (tacrolimus) capsules, USP ...
These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF.
PROGRAF ® (tacrolimus) capsules, USP
PROGRAF ® (tacrolimus) injection, (for intravenous use)
Initial U.S. Approval: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
See full prescribing information for complete boxed warning
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Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression (5.2)
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Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections (5.3, 5.4, 5.5)
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Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf (5.1)
INDICATIONS AND USAGE
Prograf is a calcineurin-inhibitor immunosuppressant indicated for
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Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants ( 1.1, 1.2, 1.3)
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Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) ( 1.1, 1.2, 1.3)
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Limitations of Use ( 1.4):
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Do not use simultaneously with cyclosporine
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Intravenous use reserved for patients who can not tolerate capsules orally
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Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established
DOSAGE AND ADMINISTRATION
Summary of Initial Oral Dosage Recommendation and Observed Whole Blood Trough Concentrations (2.1, 2.2).
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