Etanercept

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.

• Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 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.ICD-10: L40.50, L40.9, M06.9

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

Enbrel is administered by subcutaneous injection. Patient Population Recommended Dose and Frequency Adult RA and PsA ( 2.3 ) 50 mg once weekly with or without methotrexate (MTX) AS ( 2.3 ) 50 mg once weekly Adult PsO ( 2.3 ) 50 mg twice weekly for 3 months, followed by 50 mg once weekly pJIA, Pediatric PsO and JPsA ( 2.4 ) 0.8 mg/kg weekly, with a maximum of 50 mg per week 2.1 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 [see Warnings and Precautions (5.1) ]. Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with Enbrel [see Warnings and Precautions (5.8) ]. 2.2 Important Administration Instructions Administration of one 50 mg Enbrel single - dose prefilled syringe, one single - dose prefilled Enbrel SureClick autoinjector, or one Enbrel Mini single - dose prefilled cartridge (for use with the AutoTouch reusable autoinjector only), provides a dose equivalent to two 25 mg Enbrel single-dose prefilled syringes, two 25 mg single - dose vials, or two multiple-dose vials of lyophilized Enbrel, when multiple - dose vials are reconstituted and administered as recommended. 2.3 Recommended Dosage in Adult Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis Enbrel is administered by subcutaneous injection (Table 1). Table 1.

Do not start Enbrel during an active infection. If an infection develops, monitor carefully and stop Enbrel if infection becomes serious. ( 5.1 ) 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). ( 5.1 ) Demyelinating disease, exacerbation or new onset, may occur. ( 5.2 ) Cases of lymphoma have been observed in patients receiving TNF-blocking agents. ( 5.3 ) Congestive heart failure, worsening or new onset, may occur. ( 5.4 ) Advise patients to seek immediate medical attention if symptoms of pancytopenia or aplastic anemia develop, and consider stopping Enbrel. ( 5.5 ) Monitor patients previously infected with hepatitis B virus for reactivation during and several months after therapy. If reactivation occurs, consider stopping Enbrel and beginning anti-viral therapy. ( 5.6 ) Anaphylaxis or serious allergic reactions may occur. ( 5.7 ) Stop Enbrel if lupus-like syndrome or autoimmune hepatitis develops. ( 5.9 ) 5.1 Serious Infections Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF-blockers.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Neurologic Reactions [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Patients with Heart Failure [see Warnings and Precautions (5.4) ] Hematologic Reactions [see Warnings and Precautions (5.5) ] Hepatitis B Reactivation [see Warnings and Precautions (5.6) ] Allergic Reactions [see Warnings and Precautions (5.7) ] Autoimmunity [see Warnings and Precautions (5.9) ] Immunosuppression [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence > 5%): infections and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events [see Warnings and Precautions (5) ] . The most common adverse reactions with Enbrel were infections and injection site reactions. Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice.

8.1 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 study in pregnant women with chronic inflammatory disease. Both the OTIS Registry and the Scandinavian study showed the proportion of liveborn infants with major birth defects was higher for women exposed to etanercept compared to diseased etanercept unexposed women. However, the lack of pattern of major birth defects is reassuring and differences between exposure groups (e.g., disease severity) may have impacted the occurrence of birth defects (see Data ). Reports of etanercept use during the third trimester of pregnancy demonstrated that placental transfer of etanercept was low in infants at birth (see Data ) . There are risks to the mother and fetus associated with active rheumatoid arthritis. The theoretical risks of administration of live or live-attenuated vaccines to the infants exposed in utero to Enbrel should be weighed against the benefits of vaccinations (see Clinical Considerations ) .

Metabolism

After administration of 25 mg of Enbrel by a single SC injection to 25 patients with RA, a mean ± standard deviation half-life of 102 ± 30 hours was observed with a clearance of 160 ± 80 mL/hr. A maximum serum concentration (C max ) of 1.1 ± 0.6 mcg/mL and time to C max of 69 ± 34 hours was observed in these patients following a single 25 mg dose.

No dose-limiting toxicities have been observed during clinical trials of Enbrel. Single IV doses up to 60 mg/m 2 (approximately twice the recommended dose) have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities.

• Nov 2, 1998BLABLA103795Immunex

1. 1Drug Ineffective75,21013%
2. 2Injection Site Pain56,7019.6%
3. 3Rheumatoid Arthritis46,3707.8%
4. 4Arthralgia45,1367.6%
5. 5Pain43,1997.3%
6. 6Injection Site Erythema41,0266.9%
7. 7Fatigue30,4155.1%
8. 8Joint Swelling25,5494.3%
9. 9Pain In Extremity25,5304.3%
10. 10Psoriasis25,0324.2%
11. 11Headache24,8034.2%
12. 12Injection Site Swelling23,2623.9%
13. 13Off Label Use22,3143.8%
14. 14Injection Site Pruritus22,0943.7%
15. 15Injection Site Reaction20,8863.5%

Recent PubMed references pinned to Etanercept as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Possible Association Between Etanercept Use During Breastfeeding and Infant Somnolence, Hypotonia, and Feeding Difficulties: A Case Report and Literature Review.
  Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2026 · Eskiyurt B, Horoz E, Bakırlı DC, et al.
  PMID 42093128DOI 10.1177/15568253261446227
• Predictors of inactive disease and remission in children and young adults with juvenile idiopathic arthritis treated with etanercept.
  Rheumatology (Oxford, England) · 2026 · Chasnyk V, Constantin T, Nikishina I, et al.
  PMID 42011511DOI 10.1093/rheumatology/keag198
• Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein as Treatment for Gout Flare.
  International journal of rheumatic diseases · 2026 · Luo J, Xie Z, Zhang W, et al.
  PMID 41949339DOI 10.1111/1756-185x.70638
• Computational modeling-directed combination treatment with etanercept and mifepristone mitigates neuroinflammation in a mouse model of Gulf War Illness.
  PloS one · 2026 · Kelly KA, Felton CM, Billig BK, et al.
  PMID 41843558DOI 10.1371/journal.pone.0324577
• Effects of sialylated oligosaccharides on the N- and O-glycosylation of etanercept in recombinant CHO cells.
  Applied microbiology and biotechnology · 2026 · Kim TH, Lee HM, Ryu SH, et al.
  PMID 41826544DOI 10.1007/s00253-026-13778-1
• Improvement of protein purity in etanercept production through process optimization in recombinant CHO cell-based transient gene expression system.
  Bioprocess and biosystems engineering · 2026 · Kim HS, Lee HM, Kim TH, et al.
  PMID 41801332DOI 10.1007/s00449-026-03307-9
• Tumor necrosis factor alpha inhibition improves fetal growth in a rat model of preeclampsia.
  Placenta · 2026 · Coats LE, Campbell N, Solise D, et al.
  PMID 41671937DOI 10.1016/j.placenta.2026.02.002
• Structural modifications of the tumor necrosis factor-α inhibitor Enbrel affect its therapeutic efficacy in a mouse model of rheumatoid arthritis.
  The Journal of pharmacology and experimental therapeutics · 2026 · Birnboim-Perach R, Aharon A, Amir A, et al.
  PMID 41633063DOI 10.1016/j.jpet.2026.103804

The 10 most recently updated of 509 ClinicalTrials.gov registrations naming Etanercept as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Anti-inflammatory Therapy to Improve Outcomes After TPIAT
  Completed · Phase 4 · Interventional · 43 enrolled · University of Minnesota
  NCT02713997updated 2026-06-09
• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
  Active not recruiting · Phase 3 · Interventional · 120 enrolled · Janssen Research & Development, LLC
  NCT03451851updated 2026-06-08
• Psoriasis Longitudinal Assessment and Registry
  Active not recruiting · Observational · 15,849 enrolled · Janssen Scientific Affairs, LLC
  NCT00508547updated 2026-06-05
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
  Recruiting · Phase 3 · Interventional · 400 enrolled · Duke University
  NCT06654882updated 2026-06-01
• Safety of a Strategy Combining Etanercept Administration With Repeated Contrast Ultrasound in Patients With Alzheimer's Disease
  Recruiting · Phase 1 · Interventional · 5 enrolled · Fondation Ophtalmologique Adolphe de Rothschild
  NCT06585384updated 2026-05-12
• Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT
  Terminated · Phase 2 · Interventional · 12 enrolled · Mats Remberger
  NCT04118556updated 2026-05-06
• Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout
  Completed · Interventional · 26 enrolled · Lihua Duan
  NCT05925166updated 2026-04-15
• A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 135 enrolled · Sun Pharmaceutical Industries Limited
  NCT03997786updated 2026-04-15
• Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
  Active not recruiting · Phase 2 · Interventional · 49 enrolled · medac GmbH
  NCT06075706updated 2026-04-14

CPIC-curated drug–gene pairs for Etanercept. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• TNFCPIC C (provisional)ClinPGx 2B

Frequently asked questions

How does Etanercept work?

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.

What is Etanercept used for?

According to FDA labeling, Etanercept carries indications including: Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Etanercept?

Etanercept is classified as Tumor necrosis factor alpha (TNF-alpha) inhibitors, Tumor Necrosis Factor Blocker, Biological Response Modifiers, Tumor Necrosis Factor alpha Receptor Blocking Activity, Tumor Necrosis Factor beta Receptor Blocking Activity, Tumor Necrosis Factor Receptor Blocking Activity, Immunologic Activity Alteration.

What are the brand names for Etanercept?

Etanercept is marketed under brand names including Enbrel, Eticovo.

What are the contraindications for Etanercept?

Etanercept labeling lists contraindications including: Enbrel is contraindicated in patients with sepsis. Enbrel is contraindicated in patients with sepsis.. Always consult the full prescribing information and a clinician.