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The maximum tolerated dose of Enbrel has not been established in humans. Single IV doses up to 60 mg/m2 have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities. The highest dose level evaluated in RA patients has been an IV loading dose of 32 mg/m2 followed by SC doses of 16 mg/m2 (~25 mg) administered twice weekly.
Enbrel did not induce lethality or notable signs of toxicity in mice or rats following a single SC dose of 2000 mg/kg or a single IV dose of 1000 mg/kg. Enbrel did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly SC administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were >27-fold higher than that obtained in humans at the recommended human dose of 25 mg.
No dose-limiting toxicities were observed during clinical trials of RA patients.
There is no known antidote to Enbrel.
