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U.S. Department of Health and Human Services


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Myfortic (mycophenolic acid) Delayed-Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008


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


  • Lymphoma and Other Malignancies
  • Progressive Multifocal Leukoencephalopathy (PML)


  • Postmarketing Experience (new subsection)
    • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal...
    • Congenital malformations have been reported in offspring of patients...

Lymphoma and Other Malignancies

...The rates for lymphoproliferative disease or lymphoma in Myfortic-treated patients were comparable to the mycophenolate mofetil group in the de novo and maintenance studies. As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.

Progressive Multifocal Leukoencephalopathy (PML)

Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil (MMF)...