Roche revises CellCept's prescribing information

July 2, 2008

Changes have been made to the Warnings and Adverse Reactions sections to the immunosuppressant.

Roche Laboratories has announced that it has made changes to the Warnings and Adverse Reactions sections to the immunosuppressant CellCept (mycophenolate mofetil). The changes were made as a result of postmarketing data, which found that the antirejection drug has been associated with cases of progressive multifocal leukoencephalopathy (PML). Back in April the Food & Drug Administration had issued an early warning about the link between PML and the drug. CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. The agent should be used concomitantly with cyclosporine and corticosteroids.

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