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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 39-week study in rhesus monkeys followed by a 13-week recovery period, the no observable effect level was set at the highest dose level of 24 mg/kg/week, leading to exposure values greater than 1,000-times the systemic exposure (AUC) in renal transplant patients given the recommended clinical dose together with concomitant immunosuppressive therapy.
