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CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI

mmunosuppressant 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,

physicians should also consider the risk that reduced immunosuppression

represents to the graft.

-- CellCept can cause fetal harm when administered to a pregnant woman. A

patient who is planning a pregnancy should not use CellCept unless she

cannot be successfully treated with other immunosuppressant drugs. If

this drug is used during pregnancy, or if the patient becomes pregnant

while taking this drug, the patient should be apprised of the potential

hazard to the fetus.

-- Women of childbearing potential (including pubertal girls and

peri-menopausal women) taking CellCept must receive contraceptive

counseling and use effective contraception. The patient should begin

using her chosen contraceptive method 4 weeks prior to starting

CellCept therapy. She should continue contraceptive use during therapy

and for 6 weeks after stopping CellCept. Two reliable forms of

contraception must be used simultaneously unless abstinence is the

chosen method. Patients should be aware that CellCept reduces blood

levels of the hormones in the oral contraceptive pill and could

theoretically reduce its effectiveness.

-- Severe neutropenia [absolute neutrophil count (ANC)

<0.5 x 10cubed/microL] developed in up to 2.0% of renal, up to 2.8% of

cardiac, and up to 3.6% of hepatic transplant patients receiving

CellCept 3 g daily. Patients receiving CellCept should b

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