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Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function
Date:6/1/2008

pression 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

immunosuppressant therapies and impairment of immune function. In

immunosuppressed patients, physicians should consider PML in the

differential diagnosis in patients reporting neurological symptoms and

consultation with a neurologist should be considered as clinically

indicated. Consideration should be given to reducing the amount of

immunosuppression in patients who develop PML. In transplant patients,
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SOURCE Roche
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