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Label Changes for:

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

May 2008

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


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

WARNINGS

  • Lymphoma and Malignancy
  • Infections
  • Progressive Multifocal Leukoencephalopathy (PML)

ADVERSE REACTIONS

  • See highlighted text for revised labeling
  • Postmarketing Experience
    • Resistance Mechanism Disorders
      • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal...

WARNINGS

Lymphoma and Malignancy

Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving CellCept (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of renal, cardiac, and hepatic transplant patients.

In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.

Infections

Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis. In patients receiving CellCept (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients.

Progressive Multifocal Leukoencephalopathy (PML)

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

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