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In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity was observed after single oral doses of 2000 mg/kg (limit test) in either mice or rats.
Reported experience with overdose in humans is very limited. There is a single case of an accidental ingestion of everolimus 1.5 mg by a 2-year old child, but no adverse events were observed. Single doses up to 25 mg have been administered to transplant patients with acceptable acute tolerability.
General supportive measures should be initiated in all cases of overdose.
