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CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI
Date:6/4/2008

entration-controlled CellCept and reduced level of CNI group (p<0.001) at most time points, significantly fewer CellCept withdrawals occurred versus the other two groups.

CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.

Important Safety Information:

WARNING:

Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Female users of childbearing potential must use contraception. Physicians should inform female patients that CellCept use during pregnancy is associated with increased rates of pregnancy loss and congenital malformations.
-- Patients receiving immunosuppressive regimens involving combinations of

drugs, including CellCept, as part of an immunosuppressive regimen are

at increased risk of developing lymphomas and other malignancies,

particularly of the skin.

-- Oversuppression of the immune system can also increase susceptibility

to infection, including opportunistic infections, and sepsis.

-- Cases of progressive multifocal leukoencephalopathy (PML), sometimes

fatal, have been reported in patients treated with CellCept.

Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were

the most frequent clinical features observed. The reported cases

generally had risk factors for PML, including treatment with

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SOURCE Roche
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