Enbrel

Enbrel Overdosage

etanercept

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Overdosage
The maximum tolerated dose of etanercept has not been established in humans. Single intravenous 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 rheumatoid arthritis patients has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 (~25 mg) administered twice weekly.
Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg. Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 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 rheumatoid arthritis patients.
There is no known antidote to etanercept.
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