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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