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Prograf (tacrolimus) Injection, 5 mg/ml February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Nephrotoxicity
  • Neurotoxicity
  • Latent Viral Infections
  • Prograf in Combination with MMF or Sirolimus



  • Nephrotoxicity
    • can cause nephrotoxicity, particularly when used in high doses...
  • Neurotoxicity
    • can cause neurotoxicity, particularly when used in high doses
    • Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES)...
  • Latent Viral Infections
    • Immunosuppressed patients are at increased risk for opportunistic infections...
  • Prograf in Combination with MMF or Sirolimus
    • In one randomized, open-label, multi-center trial... A safe and effective dosing regimen of MMF in combination with Prograf has not been established in kidney transplantation.
    • The use of full-dose Prograf with sirolimus (2 mg per day) in heart transplant recipients...


  • Other Drug Interactions
    • a second paragraph added...At a given MMF dose, mycophenolic acid (MPA) exposure is higher with Prograf co-administration than with cyclosporine co-administration...


  • Urogenital
    • BK nephropathy
  • Post Marketing/Nervous System
    • posterior reversible encephalopathy syndrome (PRES), progressive multifocal
      leukoencephalopathy (PML)
  • Post Marketing/Respiratory
    • interstitial lung disease