Molecule
Etanercept is a tumor necrosis factor blocker indicated for the treatment of adult patients with, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Etanercept for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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
Source: US FDA prescribing information
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. Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface TNFRs, rendering TNF biologically inactive.
Source: US FDA prescribing information
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
Source: US FDA prescribing information
Enbrel is contraindicated in patients with sepsis.
Source: US FDA prescribing information
Boxed warning (serious infections and malignancies warning: serious infections and malignancies serious infections): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. 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.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections Neurologic Reactions Malignancies Patients with Heart Failure Hematologic Reactions Hepatitis B Reactivation Allergic Reactions Autoimmunity Immunosuppression Most common adverse reactions (incidence > 5%): infections and injection site reactions.
Source: US FDA prescribing information
Specific drug interaction studies have not been conducted with Enbrel. Live vaccines – Avoid concurrent administration with Enbrel. Anakinra – Increased risk of serious infection. Abatacept – Increased risk of serious adverse events, including infections. Cyclophosphamide – Not recommended for use with Enbrel.
Source: US FDA prescribing information
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 FREEZE. For convenience, storage of individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 30 days is permissible, with protection from light and sources of heat. Once a single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge has been stored at room temperature, it should not be placed back into the refrigerator.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Etanercept, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Enbrel 50 mg/1 mL injectionSubcutaneous Cold chain | Immunex | US FDA | Available on request |
| Enbrel 25 mg/0.5 mL injectionSubcutaneous Cold chain | Immunex | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Etanercept in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Etanercept and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Etanercept, including Enbrel.
Yes. The US FDA first approved Etanercept on 2 November 1998, according to Drugs@FDA.
Yes. Etanercept has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Etanercept must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Etanercept is classified under ATC code L04AB01 (Etanercept).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.