Prograf (Tacrolimus) - Warnings and PrecautionsRx drug information, pharmaceutical research, clinical trials, news, and more Summary Description Indications and Dosage Warnings and Precautions Side Effects and Adverse Reactions Drug Interactions, Overdosage and Contraindications Clinical Pharmacology Other Rx Information Active Ingredients Adverse Event Reports Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Prograf can cause neurotoxicity and nephrotoxicity, particularly when used in high doses. Nephrotoxicity was reported in approximately 52% of kidney transplantation patients and in 40% and 36% of liver transplantation patients receiving Prograf in the U.S. and European randomized trials, respectively, and in 59% of heart transplantation patients in a European randomized trial (see ADVERSE REACTIONS). Use of Prograf with sirolimus in heart transplantation patients in a US study was associated with increased risk of renal function impairment, and is not recommended (See CLINICAL STUDIES). More overt nephrotoxicity is seen early after transplantation, characterized by increasing serum creatinine and a decrease in urine output. Patients with impaired renal function should be monitored closely as the dosage of Prograf may need to be reduced. In patients with persistent elevations of serum creatinine who are unresponsive to dosage adjustments, consideration should be given to changing to another immunosuppressive therapy. Care should be taken in using tacrolimus with other nephrotoxic drugs.
