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In clinical studies, Simulect has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no untoward acute effects.
In a 4-weekly study in rhesus monkeys, the no observable effect level was 5 mg/kg twice weekly, leading to a serum Cmax of 170 mcg/mL. Levels in humans are generally <10 mcg/mL with the recommended regimen.
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