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
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Sections Modified
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Summary of Changes to Contraindications and Warnings
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WARNINGS
- Nephrotoxicity
- Neurotoxicity
- Latent Viral Infections
- Prograf in Combination with MMF or Sirolimus
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WARNINGS
- 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...
PRECAUTIONS
- 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...
ADVERSE REACTIONS
- Urogenital
- Post Marketing/Nervous System
- posterior reversible encephalopathy syndrome (PRES), progressive multifocal
leukoencephalopathy (PML)
- Post Marketing/Respiratory
- interstitial lung disease
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