Etanercept

What it is and how it works

Mechanism of Action TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory processes of RA, polyarticular JIA, PsA, and AS and the resulting joint pathology. In addition, TNF plays a role in the inflammatory process of PsO. Elevated levels of TNF are found in involved tissues and fluids of patients with RA, JIA, PsA, AS, and PsO. Two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75), exist naturally as monomeric molecules on cell surfaces and in soluble forms. Biological activity of TNF is dependent upon binding to either cell surface TNFR.

Mechanism class: Tumor Necrosis Factor Receptor Blocking Activity

Indications

Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Ankylosing Spondylitis (AS) Plaque Psoriasis (PsO) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) Plaque Psoriasis, 4 years of age or older Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

Dosage and administration (summary)

Enbrel is administered by subcutaneous injection. Patient Population Recommended Dose and Frequency Adult RA and PsA 50 mg once weekly with or without methotrexate (MTX) AS 50 mg once weekly Adult PsO 50 mg twice weekly for 3 months, followed by 50 mg once weekly pJIA, Pediatric PsO and JPsA 0.8 mg/kg weekly, with a maximum of 50 mg per week Testing and Procedures Prior to Treatment Initiation Perform the following evaluations and procedures prior to initiating treatment with Enbrel: Prior to initiating Enbrel and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection .

Contraindications

Enbrel is contraindicated in patients with sepsis. Enbrel is contraindicated in patients with sepsis.

Warnings and precautions

Do not start Enbrel during an active infection. If an infection develops, monitor carefully and stop Enbrel if infection becomes serious. Consider empiric anti-fungal therapy for patients at risk for invasive fungal infections who develop a severe systemic illness on Enbrel (those who reside or travel to regions where mycoses are endemic). Demyelinating disease, exacerbation or new onset, may occur. Cases of lymphoma have been observed in patients receiving TNF-blocking agents. Congestive heart failure, worsening or new onset, may occur.

Pregnancy

Pregnancy Risk Summary Available studies with use of etanercept during pregnancy do not reliably support an association between etanercept and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS) Enbrel Pregnancy Registry in women with rheumatic diseases or psoriasis and a Scandinavian …

Storage and supply

Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage. Do not store Enbrel in extreme heat or cold. DO NOT SHAKE. DO NOT FREEZE.

Source: Etanercept (Enbrel) — US FDA prescribing information, 2026-05-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.