Clinical trials have been conducted with exemestane given as a
single dose to healthy female volunteers at doses as high as 800 mg and daily
for 12 weeks to postmenopausal women with advanced breast cancer at doses as
high as 600 mg. These dosages were well tolerated. There is no specific antidote
to overdosage and treatment must be symptomatic. General supportive care,
including frequent monitoring of vital signs and close observation of the
patient, is indicated.
A male child (age unknown) accidentally ingested a 25-mg tablet of
exemestane. The initial physical examination was normal, but blood tests
performed 1 hour after ingestion indicated leucocytosis (WBC 25000/mm3 with 90% neutrophils). Blood tests were repeated 4 days after
the incident and were normal. No treatment was given.
In mice, mortality was observed after a single oral dose of exemestane of
3200 mg/kg, the lowest dose tested (about 640 times the recommended human dose
on a mg/m2 basis). In rats and dogs, mortality was
observed after single oral doses of exemestane of 5000 mg/kg (about 2000 times
the recommended human dose on a mg/m2 basis) and of 3000
mg/kg (about 4000 times the recommended human dose on a mg/m2 basis), respectively.
Convulsions were observed after single doses of exemestane of 400 mg/kg and
3000 mg/kg in mice and dogs (approximately 80 and 4000 times the recommended
human dose on a mg/m2 basis), respectively.