{
 "query": "golimumab",
 "ingredient": "golimumab",
 "slug": "golimumab",
 "rxcui": "819300",
 "brands": [
  "Simponi"
 ],
 "names": [
  "golimumab"
 ],
 "classes": [
  {
   "id": "L04AB",
   "name": "Tumor necrosis factor alpha (TNF-alpha) inhibitors"
  }
 ],
 "alternatives": [
  "adalimumab",
  "certolizumab pegol",
  "etanercept",
  "infliximab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA ( 5.1 ). Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis ( 5.1 ). Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA ( 5.1 ). Monitor all patients for active TB during treatment, even if initial latent TB test is negative ( 5.1 ). Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member ( 5.2 ). SERIOUS INFECTIONS Patients treated with SIMPONI ARIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI ARIA if a ...",
  "indications_and_usage": "is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. 1.3 Ankylosing Spondylitis (AS) SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Serious Infections: Do not start SIMPONI ARIA during an active infection. If an infection develops, monitor carefully, and stop SIMPONI ARIA if infection becomes serious ( 5.1 ). Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI ARIA, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic ( 5.1 ). Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop SIMPONI ARIA and begin anti-viral therapy ( 5.1 ). Malignancies: More cases of lymphoma have been observed among patients receiving TNF blockers compared with patients in the control groups. Cases of other malignancies have been observed among patients receiving TNF blockers ( 5.2 ). Congestive Heart Failure: Worsening, or new onset, may occur. Stop SIMPONI ARIA if new or worsening symptoms occur ( 5.3 ). Demyelinating Disorders: Exacerbation or new onset may occur ( 5.4 ). Lupus-like Syndrome: Discontinue SIMPONI ARIA if symptoms develop ( 5.5 ). Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur ( 5.11 ). 5.1 Serious Infections Patients...",
  "warnings": "",
  "adverse_reactions": "The most serious adverse reactions were: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence \u2265 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction 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 reflect the rates observed in clinical practice. The safety data described below are based on one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by intravenous infusion (Trial RA). The protocol included provisions for patients taking placebo to receive treatment with SIMPONI ARIA at Week 16 or Week 24 either by patient response (based on uncon...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling (Medication Guide) . Advise patients of the potential benefits and risks of SIMPONI ARIA. Instruct patients to read the Medication Guide before starting SIMPONI ARIA therapy and to read it each time the prescription is renewed. Infections Inform patients that SIMPONI ARIA may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation. Malignancies Patients should be counseled about the risk of lymphoma and other malignancies while receiving SIMPONI ARIA. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, demyelinating disorders, autoimmune diseases, liver disease, cytopenias, or psoriasis. Vaccinations Inform patients that because SIMPONI ARIA may lower the ability of their immune system to fight infections, they should avoid live vaccines. Inform pregnant patients r...",
  "spl_medguide": "MEDICATION GUIDE SIMPONI ARIA \u00ae ( SIM-po-nee AHR-ee-uh ) (golimumab) injection, for intravenous use What is the most important information I should know about SIMPONI ARIA? SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections. Some people have serious infections while receiving SIMPONI ARIA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections. Your doctor should test you for TB and hepatitis B before starting SIMPONI ARIA. Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI ARIA. You should not start receiving SIMPONI ARIA if you have any kind of infection unless your doctor tells you to. Before receiving SIMPONI ARIA, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel ve...",
  "clinical_studies": "14.1 Rheumatoid Arthritis The efficacy and safety of SIMPONI ARIA were evaluated in one multicenter, randomized, double-blind, controlled trial (Trial RA, NCT00973479) in 592 patients \u2265 18 years of age with moderately to severely active RA despite concurrent MTX therapy and had not previously been treated with a biologic TNF-blocker. Patients were diagnosed according to the American College of Rheumatology (ACR) criteria, at least 3 months prior to administration of study agent and were required to have at least 6 swollen and 6 tender joints. Patients were randomized to receive either SIMPONI ARIA 2 mg/kg (N=395) or placebo (N=197) over a 30-minute intravenous infusion at Weeks 0, 4 and every 8 weeks thereafter in addition to their weekly maintenance MTX dose (15\u201325 mg). All patients receiving placebo + MTX received SIMPONI ARIA + MTX after Week 24, but the trial remained blinded until all patients had completed 108 weeks of treatment. Efficacy data were collected and analyzed through Week 52. Patients were allowed to continue stable doses of concomitant low dose corticosteroids (equivalent to \u2264 10 mg of prednisone a day) and/or NSAIDs. The use of other DMARDs including cytotoxic a...",
  "brand_name": "SIMPONI ARIA",
  "manufacturer": "Janssen Biotech, Inc.",
  "application_number": "BLA125433",
  "pharm_class_epc": [
   "Tumor Necrosis Factor Blocker [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20250909",
  "set_id": "9e260a47-55af-4c92-8d88-a86ccc767fff",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 80259,
  "serious": 59095,
  "death": 6238,
  "hospitalization": 18484,
  "primary_suspect": 80242,
  "top_reactions": [
   [
    "Drug Ineffective",
    21134
   ],
   [
    "Rheumatoid Arthritis",
    14292
   ],
   [
    "Pain",
    13515
   ],
   [
    "Fatigue",
    11409
   ],
   [
    "Off Label Use",
    10303
   ],
   [
    "Joint Swelling",
    9899
   ],
   [
    "Arthralgia",
    9788
   ],
   [
    "Rash",
    9517
   ],
   [
    "Alopecia",
    9425
   ],
   [
    "Drug Intolerance",
    8985
   ],
   [
    "Abdominal Discomfort",
    8841
   ],
   [
    "Swelling",
    8642
   ],
   [
    "Systemic Lupus Erythematosus",
    8561
   ],
   [
    "Contraindicated Product Administered",
    8444
   ],
   [
    "Pemphigus",
    8312
   ]
  ],
  "by_year": {
   "2019": 7018,
   "2020": 9390,
   "2021": 7421,
   "2022": 7283,
   "2023": 6577,
   "2024": 8230,
   "2025": 7135,
   "2026": 2496
  },
  "by_year_primary": {
   "2019": 7018,
   "2020": 9389,
   "2021": 7421,
   "2022": 7279,
   "2023": 6575,
   "2024": 8224,
   "2025": 7135,
   "2026": 2494
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 0,
  "anda": 0,
  "first_approval": "20090424",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "CENTOCOR ORTHO BIOTECH INC",
   "JANSSEN BIOTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/24/2009"
 },
 "trials": {
  "total": 172,
  "completed": 102,
  "terminated": 25,
  "with_results": 55,
  "industry": 97,
  "phase3": 40,
  "results_share": 0.5392156862745098,
  "terminated_share": 0.14534883720930233
 },
 "pubmed": {
  "rct": 121,
  "meta": 15,
  "recent_rct": 18,
  "cochrane": [
   {
    "pmid": "20091667",
    "title": "Golimumab for rheumatoid arthritis",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 81.35,
  "records": 3,
  "by_name": [
   [
    "Simponi",
    81.35
   ]
  ],
  "names_checked": [
   "golimumab",
   "Simponi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 31835,
  "beneficiaries": 5263,
  "spend": 230605796.54000002,
  "by_brand": [
   {
    "brand": "Simponi",
    "claims": 25616,
    "per_claim": 7210.8276148,
    "is_generic": false
   },
   {
    "brand": "Simponi Aria",
    "claims": 6219,
    "per_claim": 7379.520238,
    "is_generic": false
   }
  ],
  "per_claim": 7243.78189225695
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "golimumab",
  "matched": "golimumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "121 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $81 tied to this drug last year: negligible",
    "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": 74,
 "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, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over adalimumab, certolizumab pegol, etanercept? 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.)"
 ]
}