OVERDOSE
There has been no reported experience of overdosage of
mycophenolate mofetil in humans. The highest dose administered
to renal transplant patients in clinical trials has been
4 g/day. In limited experience with cardiac and hepatic
transplant patients in clinical trials, the highest doses
used were 4 g/day or 5 g/day. At doses of 4 g/day or 5
g/day, there appears to be a higher rate, compared to
the use of 3 g/day or less, of gastrointestinal intolerance
(nausea, vomiting, and/or diarrhea), and occasional hematologic
abnormalities, principally neutropenia, leading to a need
to reduce or discontinue dosing.
In acute oral toxicity studies, no deaths occurred in
adult mice at doses up to 4000 mg/kg or in adult monkeys
at doses up to 1000 mg/kg; these were the highest doses
of mycophenolate mofetil tested in these species. These
doses represent 11 times the recommended clinical dose
in renal transplant patients and approximately 7 times
the recommended clinical dose in cardiac transplant patients
when corrected for BSA. In adult rats, deaths occurred
after single oral doses of 500 mg/kg of mycophenolate
mofetil. The dose represents approximately 3 times the
recommended clinical dose in cardiac transplant patients
when corrected for BSA.
MPA and MPAG are usually not removed by hemodialysis.
However, at high MPAG plasma concentrations (>100 µg/mL),
small amounts of MPAG are removed. By increasing excretion
of the drug, MPA can be removed by bile acid sequestrants,
such as cholestyramine.
CONTRAINDICATIONS
Allergic reactions to CellCept have been observed; therefore,
CellCept is contraindicated in patients with a hypersensitivity
to mycophenolate mofetil, mycophenolic acid or any component
of the drug product. CellCept Intravenous is contraindicated
in patients who are allergic to Polysorbate 80 (TWEEN).
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