{
 "query": "abatacept",
 "ingredient": "abatacept",
 "slug": "abatacept",
 "rxcui": "614391",
 "brands": [
  "Orencia"
 ],
 "names": [
  "abatacept"
 ],
 "classes": [
  {
   "id": "L04AA",
   "name": "Selective immunosuppressants"
  }
 ],
 "alternatives": [
  "abetimus",
  "alefacept",
  "apremilast",
  "belatacept",
  "belumosudil",
  "cladribine",
  "efgartigimod alfa",
  "lymphocyte immune globulin, anti-thymocyte globulin, equine",
  "mycophenolic acid",
  "nerandomilast",
  "rabbit anti-human t-lymphocyte globulin",
  "remibrutinib"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is a selective T cell costimulation modulator indicated for: \u2022 the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1) \u2022 the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2) \u2022 the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3) \u2022 the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4) Limitations of Use: Concomitant use of ORENCIA with other immunosuppressives [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended. ( 1.5 , 5.1) 1.1 Adult Rheumatoid Arthritis ORENCIA \u00ae is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 1.2 Polyarticular Juvenile Idiopathic Arthritis ORENCIA is indicated for the treatment of patients 2 years of age and older with moder...",
  "contraindications": "None. None. (4)",
  "warnings_and_cautions": "\u2022 Concomitant use with a TNF antagonist can increase the risk of infections and serious infections. (5.1) \u2022 Hypersensitivity and anaphylaxis have occurred. (5.2) \u2022 Serious infections reported. Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections. Discontinue if a serious infection develops. (5.3) \u2022 Screen for latent TB infection prior to initiating therapy. Patients testing positive should be treated prior to initiating ORENCIA. (5.3) \u2022 Screen for viral hepatitis prior to initiating ORENCIA. (5.3) \u2022 Update vaccinations prior to initiating ORENCIA. Live vaccines should not be given concurrently or within 3 months of discontinuation. ORENCIA may blunt the effectiveness of some immunizations. (5.4) \u2022 COPD patients may develop more frequent respiratory adverse reactions. (5.5) \u2022 Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) reactivation in patients treated for aGVHD prophylaxis. (5.7) 5.1 Increased Risk of Infection with Concomitant Use of TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors In controlled clinical trials in patients with adult RA, patients receiving concomitant intravenous O...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors [see Warnings and Precautions (5.1) ] \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] \u2022 Infections [see Warnings and Precautions (5.3) ] \u2022 Increased Risk of Adverse Reactions When Used in Patients with Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions (5.5) ] \u2022 Immunosuppression [see Warnings and Precautions (5.6) ] \u2022 Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT) [see Warnings and Precautions (5.7) ] \u2022 Most common adverse events (\u226510%) in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. (6.1) \u2022 Most common adverse reactions (\u226510%) in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA a...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Increased Risk of Infection with Concomitant Use With Immunosuppressants for RA Inform patients that the concomitant use with other immunosuppressives (e.g., biologic DMARDs, JAK inhibitors) is not recommended [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ]. Hypersensitivity Reactions Instruct patients to immediately tell their healthcare professional if they experience symptoms of an allergic reaction on the day of administration or the day after ORENCIA administration [see Warnings and Precautions (5.2) ] . Infections Inform patients that serious infections have been reported in patients receiving ORENCIA [see Warnings and Precautions (5.3) ] . Immunizations Inform patients that live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation [see Warnings and Precautions (5.4) ] . Blood Glucose Testing Maltose is contained in ORENCIA for intravenous administration and can give falsely elevated blood glucose readings with certain blood glucose monitors on the day of ORENCIA infusion. Advise patients treated with intrav...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adult Rheumatoid Arthritis Description of Clinical Studies of Intravenous ORENCIA for the Treatment of Patients with RA The efficacy and safety of ORENCIA for intravenous administration were assessed in six randomized, double-blind, controlled studies (five placebo-controlled and one active-controlled) in patients \u226518 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria. Studies I, II, III, IV, and VI required patients to have at least 12 tender and 10 swollen joints at randomization, and Study V did not require any specific number of tender or swollen joints. ORENCIA or placebo treatment was given intravenously at weeks 0, 2, and 4 and then every 4 weeks thereafter in Studies I, II, III, IV, and VI. \u2022 Study I (NCT00279760) evaluated ORENCIA as monotherapy in 122 patients with active RA who had failed at least one non-biologic DMARD or etanercept. \u2022 In Study II (NCT00162266) and Study III (NCT00048568), the efficacy of ORENCIA were assessed in patients with an inadequate response to MTX and who were continued on their stable dose of MTX. \u2022 In Study IV (NCT00048581), the efficacy of ORENCIA was assessed in patients with an inadequat...",
  "brand_name": "ORENCIA",
  "manufacturer": "E.R. Squibb & Sons, L.L.C.",
  "application_number": "BLA125118",
  "pharm_class_epc": [
   "Selective T Cell Costimulation Modulator [EPC]"
  ],
  "route": [
   "INTRAVENOUS",
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251113",
  "set_id": "0836c6ac-ee37-5640-2fed-a3185a0b16eb",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 129358,
  "serious": 79085,
  "death": 8857,
  "hospitalization": 23936,
  "primary_suspect": 129296,
  "top_reactions": [
   [
    "Drug Ineffective",
    37866
   ],
   [
    "Rheumatoid Arthritis",
    24056
   ],
   [
    "Pain",
    21644
   ],
   [
    "Arthralgia",
    21030
   ],
   [
    "Joint Swelling",
    20456
   ],
   [
    "Fatigue",
    14135
   ],
   [
    "Contraindicated Product Administered",
    14008
   ],
   [
    "Drug Intolerance",
    13201
   ],
   [
    "Rash",
    13067
   ],
   [
    "Off Label Use",
    12099
   ],
   [
    "Arthropathy",
    11636
   ],
   [
    "Alopecia",
    10573
   ],
   [
    "Synovitis",
    10355
   ],
   [
    "Abdominal Discomfort",
    10171
   ],
   [
    "Treatment Failure",
    9894
   ]
  ],
  "by_year": {
   "2019": 14024,
   "2020": 18066,
   "2021": 13722,
   "2022": 13231,
   "2023": 9505,
   "2024": 10622,
   "2025": 9654,
   "2026": 4323
  },
  "by_year_primary": {
   "2019": 14023,
   "2020": 18062,
   "2021": 13711,
   "2022": 13228,
   "2023": 9498,
   "2024": 10613,
   "2025": 9642,
   "2026": 4310
  }
 },
 "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": "20051223",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "BRISTOL MYERS SQUIBB"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/23/2005"
 },
 "trials": {
  "total": 327,
  "completed": 198,
  "terminated": 39,
  "with_results": 118,
  "industry": 198,
  "phase3": 64,
  "results_share": 0.5959595959595959,
  "terminated_share": 0.11926605504587157
 },
 "pubmed": {
  "rct": 128,
  "meta": 24,
  "recent_rct": 37,
  "cochrane": [
   {
    "pmid": "19821401",
    "title": "Abatacept for rheumatoid arthritis",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 173842.67,
  "records": 8600,
  "by_name": [
   [
    "Orencia",
    173842.67
   ]
  ],
  "names_checked": [
   "abatacept",
   "Orencia"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 124711,
  "beneficiaries": 17660,
  "spend": 754104202.24,
  "by_brand": [
   {
    "brand": "Orencia Clickject",
    "claims": 94624,
    "per_claim": 6025.7934156,
    "is_generic": false
   },
   {
    "brand": "Orencia",
    "claims": 30087,
    "per_claim": 6112.9233915,
    "is_generic": false
   }
  ],
  "per_claim": 6046.813851544772
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 24565,
  "fills": 124711,
  "per_million": 196975.40714131072,
  "ratio": 71.13722698350495,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "196,975 FDA reports naming it as the suspect drug per million Medicare fills, 71.1x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "128 randomized trials and 24 systematic reviews/meta-analyses indexed in PubMed",
    "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": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $173,843 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)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "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 abetimus, alefacept, apremilast? 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.)"
 ]
}