Full Prescribing Information Important Safety Information
Healthcare Professionals
Patients & Caregivers
The information provided on this website is intended for residents of the United States
Indication
  • Prograf® (tacrolimus) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally. In heart transplant recipients, it is recommended that Prograf be used in conjunction with azathioprine or mycophenolate mofetil. The safety and efficacy of the use of Prograf with sirolimus has not been established.
Important Safety Information
WARNING
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. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
  • Prograf is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with a hypersensitivity to castor oil. Patients receiving Prograf injection should be under continuous observation for at least the first 30 minutes following the start of infusion and at frequent intervals thereafter. If signs or symptoms of anaphylaxis occur, the infusion should be stopped.
  • Insulin-dependent post-transplant diabetes mellitus was reported in 11% to 22% of Prograf-treated liver, kidney, and heart transplant patients with no prior history of diabetes mellitus. Black and Hispanic kidney transplant patients were at increased risk. Insulin dependence was reversible in 15% to 45% of patients at 1 year.
  • Prograf has been associated with nephrotoxicity, particularly when used in high doses. In particular, to avoid excess nephrotoxicity, Prograf should not be used simultaneously with cyclosporine. Prograf or cyclosporine should be discontinued at least 24 hours prior to initiating the other. In the presence of elevated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed.
  • Use of Prograf with sirolimus in heart transplant patients in a US study was associated with increased risk of wound healing complications, renal function impairment, and insulin-dependent post-transplant diabetes, and is not recommended.
  • A safe and effective dosing regimen of mycophenolate mofetil (MMF) in combination with Prograf has not been established in kidney transplantation. In one clinical study, 12-month mortality was 4.2% in patients receiving Prograf/MMF compared with 2.4% in patients receiving cyclosporine/MMF.
  • Mild to severe hyperkalemia was reported in 31% of kidney transplant recipients, in 45% and 13% of liver transplant recipients in the US and European randomized trials, respectively, and in 8% of heart transplant recipients in a European randomized trial, and may require treatment. Serum potassium levels should be monitored and potassium-sparing diuretics should not be used during Prograf therapy (see PRECAUTIONS).
  • Neurotoxicity, including tremor, headache, and other changes in motor function, mental status, and sensory function, was reported in approximately 55% of liver transplant recipients in the two randomized studies. Tremor occurred more often in Prograf-treated kidney transplant (54%) and heart transplant patients (15%) compared with cyclosporine-treated patients. Seizures have occurred in adult and pediatric patients receiving Prograf. Coma and delirium also have been associated with high plasma concentrations of tacrolimus.
  • In postmarketing experience, patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES). If PRES is suspected or diagnosed, immediate reduction of immunosuppression is advised. Activation of latent viral infections, including BK virus-associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML), has also been reported.
  • The principal adverse reactions of Prograf include tremor, headache, hypertension, gastrointestinal disturbance, abnormal renal function, hyperglycemia, leukopenia, CMV infection, infection, and hyperlipemia.