{
 "query": "etanercept",
 "ingredient": "etanercept",
 "slug": "etanercept",
 "rxcui": "214555",
 "brands": [
  "Enbrel"
 ],
 "names": [
  "etanercept"
 ],
 "classes": [
  {
   "id": "L04AB",
   "name": "Tumor necrosis factor alpha (TNF-alpha) inhibitors"
  }
 ],
 "alternatives": [
  "adalimumab",
  "certolizumab pegol",
  "golimumab",
  "infliximab"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. 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. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting Enbrel. ( 5.1 ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Enbrel. ( 5.3 ) SERIOUS INFECTIONS Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexa...",
  "indications_and_usage": "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. 1.2 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. 1.3 Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical ...",
  "contraindications": "Enbrel is contraindicated in patients with sepsis. Enbrel is contraindicated in patients with sepsis. ( 4 )",
  "warnings_and_cautions": "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 vario...",
  "warnings": "",
  "adverse_reactions": "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. Becaus...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Juvenile Psoriatic Arthritis ( 1.6 ) 10/2023 Dosage and Administration, Pediatric Patients ( 2.4 ) 10/2023",
  "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Enbrel, and each time the prescription is renewed, as there may be new information they need to know. Patients or their caregivers should be provided the Enbrel \"Medication Guide\" and provided an opportunity to read it and ask questions prior to initiation of therapy. The healthcare provider should ask the patient questions to determine any risk factors for treatment. Patients developing signs and symptoms of infection should seek medical evaluation immediately. Patient Counseling Patients should be advised of the potential benefits and risks of Enbrel. Physicians should instruct their patients to read the Medication Guide before starting Enbrel therapy and to reread each time the prescription is renewed. Infections Inform patients that Enbrel may lower the ability of their immune system to fight infections. Advise patients of the importance of contacting their doctor if they develop any symptoms of infection, tuberculosis or reactivation of hepatitis B virus infections. Other Medical Conditions Advise patients to report any signs...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 09/2024 Medication Guide Enbrel \u00ae (en-brel) (etanercept) injection, for subcutaneous use Enbrel \u00ae (en-brel) (etanercept) for injection, for subcutaneous use Read the Medication Guide that comes with Enbrel before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. It is important to remain under your healthcare provider's care while using Enbrel. Enbrel is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that affects your immune system. What is the most important information I should know about Enbrel? Enbrel may cause serious side effects, including: 1. Risk of Infection 2. Risk of Cancer 1. Risk of infection Enbrel can lower the ability of your immune system to fight infections. Some people have serious infections while taking Enbrel. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections. Your h...",
  "clinical_studies": "14.1 Adult Rheumatoid Arthritis The safety and efficacy of Enbrel were assessed in four randomized, double-blind, controlled studies. The results of all four trials were expressed in percentage of patients with improvement in RA using ACR response criteria. Study I evaluated 234 patients with active RA who were \u2265 18 years old, had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs) (e.g. hydroxychloroquine, oral or injectable gold, MTX, azathioprine, D-penicillamine, sulfasalazine), and had \u2265 12 tender joints, \u2265 10 swollen joints, and either erythrocyte sedimentation rate (ESR) \u2265 28 mm/hr, C-reactive protein (CRP) > 2.0 mg/dL, or morning stiffness for \u2265 45 minutes. Doses of 10 mg or 25 mg Enbrel or placebo were administered SC twice a week for 6 consecutive months. Study II evaluated 89 patients and had similar inclusion criteria to Study I except that patients in Study II had additionally received MTX for at least 6 months with a stable dose (12.5 to 25 mg/week) for at least 4 weeks and they had at least 6 tender or painful joints. Patients in Study II received a dose of 25 mg Enbrel or placebo SC twice a week for 6 months in addit...",
  "brand_name": "ENBREL",
  "manufacturer": "Immunex Corporation",
  "application_number": "BLA103795",
  "pharm_class_epc": [
   "Tumor Necrosis Factor Blocker [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260511",
  "set_id": "a002b40c-097d-47a5-957f-7a7b1807af7f",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 377056,
  "serious": 157358,
  "death": 12288,
  "hospitalization": 41560,
  "primary_suspect": 376988,
  "top_reactions": [
   [
    "Drug Ineffective",
    64590
   ],
   [
    "Rheumatoid Arthritis",
    35423
   ],
   [
    "Pain",
    34835
   ],
   [
    "Arthralgia",
    29978
   ],
   [
    "Injection Site Pain",
    25119
   ],
   [
    "Fatigue",
    22019
   ],
   [
    "Off Label Use",
    21926
   ],
   [
    "Joint Swelling",
    20341
   ],
   [
    "Injection Site Erythema",
    17864
   ],
   [
    "Condition Aggravated",
    17157
   ],
   [
    "Rash",
    16798
   ],
   [
    "Drug Intolerance",
    16473
   ],
   [
    "Pain In Extremity",
    15968
   ],
   [
    "Headache",
    15734
   ],
   [
    "Malaise",
    14980
   ]
  ],
  "by_year": {
   "2019": 31037,
   "2020": 26774,
   "2021": 17417,
   "2022": 17059,
   "2023": 13378,
   "2024": 8465,
   "2025": 7852,
   "2026": 3412
  },
  "by_year_primary": {
   "2019": 31035,
   "2020": 26766,
   "2021": 17412,
   "2022": 17046,
   "2023": 13351,
   "2024": 8459,
   "2025": 7848,
   "2026": 3411
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "19981102",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "IMMUNEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/02/1998"
 },
 "trials": {
  "total": 509,
  "completed": 351,
  "terminated": 61,
  "with_results": 193,
  "industry": 311,
  "phase3": 111,
  "results_share": 0.5498575498575499,
  "terminated_share": 0.11984282907662082
 },
 "pubmed": {
  "rct": 360,
  "meta": 48,
  "recent_rct": 30,
  "cochrane": [
   {
    "pmid": "23728649",
    "title": "Etanercept for the treatment of rheumatoid arthritis",
    "year": "2013"
   },
   {
    "pmid": "14584021",
    "title": "Etanercept for the treatment of rheumatoid arthritis",
    "year": "2003"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 656058.59,
  "records": 33512,
  "by_name": [
   [
    "Enbrel",
    656058.59
   ]
  ],
  "names_checked": [
   "etanercept",
   "Enbrel"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 409277,
  "beneficiaries": 53261,
  "spend": 3225567875.91,
  "by_brand": [
   {
    "brand": "Enbrel Sureclick",
    "claims": 296022,
    "per_claim": 7895.1999144,
    "is_generic": false
   },
   {
    "brand": "Enbrel",
    "claims": 80845,
    "per_claim": 7827.2178968,
    "is_generic": false
   },
   {
    "brand": "Enbrel Mini",
    "claims": 32410,
    "per_claim": 7887.1822259,
    "is_generic": false
   }
  ],
  "per_claim": 7881.136433051453
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "etanercept",
  "matched": "etanercept",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 19718,
  "fills": 409277,
  "per_million": 48177.64008238919,
  "ratio": 17.39924677811086,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "48,178 FDA reports naming it as the suspect drug per million Medicare fills, 17.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "360 randomized trials and 48 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $656,059 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are rheumatoid arthritis, pain, arthralgia. How would we recognize and handle those?",
  "Why this one over adalimumab, certolizumab pegol, golimumab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}