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Label Changes for:

Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mg

February 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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.

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