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In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity were observed in either mice or rats given single oral doses of 2,000 mg/kg (limit test).
Reported experience with overdose in humans is very limited. There was a single case of accidental ingestion of 1.5 mg everolimus by a 2-year old child, but no adverse events were observed. Single doses of 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.
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