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etanercept

Enbrel · ATC code L04AB01

Key facts
Active substance
etanercept
Drug class
Immunosuppressive drug
ATC code
L04AB01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Enbrel 25 mg powder for solution for injection · Enbrel 25 mg powder and solvent for solution for injection · Enbrel 25 mg solution for injection in pre-filled syringe / Enbrel 50 mg solution for injection in pre-filled syringe · Enbrel 25 mg solution for injection in pre-filled pen / Enbrel 50 mg solution for injection in pre-filled pen · Enbrel 10 mg powder and solvent for solution for injection for paediatric use · Enbrel 25 mg solution for injection in dose-dispenser cartridge / Enbrel 50 mg solution for injection in dose-dispenser cartridge
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-27

Key facts

Etanercept is a TNF-alpha inhibitor (fusion protein) and biological immunosuppressant. It is used in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

What it is used for

  • Moderate to severe active rheumatoid arthritis in adults (with methotrexate or as monotherapy); also severe RA not previously treated with methotrexate
  • Juvenile idiopathic arthritis (polyarthritis, extended oligoarthritis and other forms)
  • Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
  • Moderate to severe plaque psoriasis in adults who failed other systemic therapy
  • Chronic severe plaque psoriasis in children and adolescents (age limits in the full text)

Dosing

  • Rheumatoid arthritis: 25 mg twice weekly or 50 mg once weekly subcutaneously
  • Psoriatic arthritis and axial spondyloarthritis: 25 mg twice weekly or 50 mg once weekly
  • Plaque psoriasis: 25 mg twice weekly or 50 mg once weekly; alternatively 50 mg twice weekly for up to 12 weeks
  • Juvenile idiopathic arthritis: 0.4 mg/kg (maximum 25 mg) twice weekly or 0.8 mg/kg (maximum 50 mg) once weekly
  • Clinical response is usually achieved within 12 weeks; continued therapy in non-responders should be reconsidered
  • Initiated and supervised by experienced specialists; patients receive the Patient Card

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Sepsis or risk of sepsis
  • Active infections, including chronic or localised infections (treatment should not be initiated)

Important warnings

  • Serious infections, sepsis, tuberculosis and opportunistic infections (e.g. invasive fungal infections, listeriosis) reported, sometimes fatal; evaluate for infections before, during and after treatment
  • Hepatitis B reactivation possible; test for HBV before starting
  • Malignancies including lymphoma and skin cancer reported
  • Rare serious haematological, neurological (demyelinating) and autoimmune reactions

Side effects

  • Most common: injection site reactions (pain, swelling, itching, reddening, bleeding)
  • Infections (upper respiratory, bronchitis, bladder, skin), headache, allergic reactions, autoantibodies, itching, fever
  • Serious infections in fewer than 1 in 100 patients; rare pancytopenia, very rare aplastic anaemia

Interactions

  • Anakinra: higher rate of serious infections and neutropenia; combination not recommended
  • Abatacept: increased serious adverse events; combination not recommended
  • Sulfasalazine: see the full text

Pregnancy and breastfeeding

  • Women of childbearing potential should consider contraception during therapy and for three weeks after; one observational study found a higher rate of major birth defects
  • Breast-feeding: may be considered weighing the benefit of breast-feeding and of therapy; detected at low levels in human milk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Benepali · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/004007
  • EnbrelPfizer Europe MA EEIG · EMEA/H/C/000262
  • Erelzi · biosimilarSandoz GmbH · EMEA/H/C/004192
  • Fubelv · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/006738
  • Nepexto · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/004711

Source: European Medicines Agency (EMA), product information

Turkey

  • EnbrelPFİZER PFE İLAÇLARI A.Ş. · 7 register entries
  • EnerceptanCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • ErelziSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 9 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Enbrel, Erelzi, Fubelv, Nepexto
Liechtenstein
Enbrel, Erelzi, Fubelv, Nepexto
Norway
Enbrel, Erelzi, Fubelv, Nepexto

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Enbrel – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/enbrel-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AB.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.