Doses higher than 25 mg twice weekly are not recommended.
Children (4 to 17 years of age): The recommended dose of etanercept for children 4 to 17 years of age with active polyarticular-course JRA is 0.4 mg/kg (upto a maximum of 25 mg/dose). Given SC twice weekly 72 to 96 hours apart. Glucocorticoids, NSAIDS, or analgesics may be continued during treatment with etanercept.
Etanercept has been studied in approximately 1200 patients with RA, followed for up to 36 months and in 157 patients with psoriatic arthritis for 6 months. The proportion of patients who discontinued treatment because of adverse events was approximately 4% in etanercept and placebo treated patients. The vast majority of these patients were treated with recommended dose 25 mg SC twice daily.
In controlled trials of RA and psoriatic arthritis, rates of serious adverse events were seen at a frequency of approximately 5% among etanercept - and control -treated patients. Among RA patients in placebo-controlled, active-controlled, and open-label trials of etanercept, malignancies and infections were the most common serious adverse events observed. ...
Other infrequent serious adverse events observed in RA and psoriatic arthritis clinical trials included the following : Heart failure; MI; myocardial ischemia ; cerebral ischemia ; hypertension ; hypotension ; cholecystitis ; pancreatitis ; GI hemorrhage ; bursitis ; depression ; dyspnea ; deep vein thrombosis ; pulmonary embolism; membranous glomerulonephropathy ; polymyositis and thrombophlobitis.
The following serious adverse events were observed in the 50 mg twice weekly arm: GI bleeding, normal pressure hydrocephalous, seizure, and stroke. No serious adverse events were observed in the 25 mg arm (Kastrup, et al., 2003)
Etanercept Structure and Mechanism of Action
Etanercept is a fully human dimeric fusion protein consisting of the extra cellular ligand-binding domain of the 75 kilodalton (kDa). TNF- receptor linked to the Fc portion of human immunoglobulin G1 (IgG1). Despite the presence of an Fc region, etanercept does not promote complement-mediated lysis in vitro. Etanercept has been shown to have a very low (