{
 "query": "ustekinumab",
 "ingredient": "ustekinumab",
 "slug": "ustekinumab",
 "rxcui": "847083",
 "brands": [
  "Stelara",
  "Imuldosa",
  "Otulfi",
  "Pyzchiva",
  "Selarsdi",
  "Starjemza",
  "Steqeyma",
  "Wezlana",
  "Yesintek"
 ],
 "names": [
  "ustekinumab"
 ],
 "classes": [
  {
   "id": "L04AC",
   "name": "Interleukin inhibitors"
  }
 ],
 "alternatives": [
  "anakinra",
  "basiliximab",
  "bimekizumab",
  "brodalumab",
  "canakinumab",
  "daclizumab",
  "guselkumab",
  "ixekizumab",
  "mirikizumab",
  "rilonacept",
  "risankizumab",
  "sarilumab",
  "satralizumab",
  "secukinumab",
  "siltuximab",
  "spesolimab",
  "tildrakizumab",
  "tocilizumab"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 8,
   "INTRAVENOUS": 6
  },
  "boxed_warning": "",
  "indications_and_usage": "STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn's disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) 1.1. Plaque Psoriasis (PsO) STEQEYMA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2. Psoriatic Arthritis (PsA) STEQEYMA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3. Crohn's Disease (CD) STEQEYMA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4. Ulcerative Colitis STEQEYMA is indicated for the treatment of adult patients with moderately to severel...",
  "contraindications": "STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA. ( 4 )",
  "warnings_and_cautions": "Infections : Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue STEQEYMA until the infection resolves. ( 5.1 ) Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. ( 5.3 ) Malignancies : Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. ( 5.4 ) Serious Hypersensitivity Reactions : If a severe or other clinically significant hypersensitivity reaction occurs, discontinue STEQEYMA immediately and initiate appropriate medical treatment. ( 5.5 ) Posterior Reversible Encephalopathy Syndrome (PRES) : If PRES is suspected, treat promptly, and ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (\u22653%) : nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease, induction (\u22653%) : vomiting. ( 6.1 ) Crohn's Disease, maintenance (\u22653%) : nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative colitis, induction (\u22653%) : nasopharyngitis ( 6.1 ) Ulcerative colitis, maintenance (\u22653%) : nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1. Clinical Trials Experience Because clin...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 , 2.2 , 2.4 ) 06/2025 Warnings and Precautions Serious Hypersensitivity Reactions ( 5.5 ) 12/2025",
  "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that STEQEYMA may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions (5.1) ] . Malignancies Inform patients of the risk of developing malignancies while receiving STEQEYMA [see Warnings and Precautions (5.4) ] . Serious Hypersensitivity and Reactions Inform patients that serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Instruct patients to discontinue STEQEYMA and seek immediate medical attention if they experience any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ]. Posterior Reversible Encephalopathy Syndrome (PRES) Inform patients to immediately contact their healthcare provider if they experience signs and symptoms of PRES (which may include headache, seizures, confusion, or visual disturbances) [see Warnings and Precautions (5.6) ] . Immunizations Inform patients that STEQE...",
  "spl_medguide": "MEDICATION GUIDE STEQEYMA (ste-qey-ma) (ustekinumab-stba) injection, for subcutaneous or intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 2/2026 What is the most important information I should know about STEQEYMA? STEQEYMA is a medicine that affects your immune system. STEQEYMA can increase your risk of having serious side effects, including: Serious infections. STEQEYMA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Your healthcare provider should check you for TB before starting STEQEYMA. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STEQEYMA and during treatment with STEQEYMA. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with STEQEYMA. You should not start STEQEYMA if you have any kind o...",
  "clinical_studies": "14.1. Adult Subjects with Plaque Psoriasis Two multicenter, randomized, double-blind, placebo-controlled trials (Ps STUDY 1 and Ps STUDY 2) enrolled a total of 1996 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score \u226512, and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded from the trials. Ps STUDY 1 enrolled 766 subjects and Ps STUDY 2 enrolled 1230 subjects. The trials had the same design through Week 28. In both trials, subjects were randomized in equal proportion to placebo, 45 mg or 90 mg of ustekinumab. Subjects randomized to ustekinumab received 45 mg or 90 mg doses, regardless of weight, at Weeks 0, 4, and 16. Subjects randomized to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16. In both trials, subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline PGA score was marked or severe in 44% of subjects in Ps STUDY 1 and 40% of subjects in Ps STUDY 2. Approximately t...",
  "brand_name": "STEQEYMA",
  "manufacturer": "CELLTRION USA, Inc.",
  "application_number": "BLA761338",
  "pharm_class_epc": [
   "Interleukin-12 Antagonist [EPC]",
   "Interleukin-23 Antagonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS",
   "INTRAVENOUS"
  ],
  "effective_time": "20260407",
  "set_id": "66085e17-e3f2-4196-8c81-87448e804b0c",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 8",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 97073,
  "serious": 56125,
  "death": 5742,
  "hospitalization": 20986,
  "primary_suspect": 97041,
  "top_reactions": [
   [
    "Drug Ineffective",
    14549
   ],
   [
    "Off Label Use",
    12565
   ],
   [
    "Product Dose Omission Issue",
    10083
   ],
   [
    "Fatigue",
    6757
   ],
   [
    "Pain",
    6165
   ],
   [
    "Psoriasis",
    6098
   ],
   [
    "Crohn^S Disease",
    5847
   ],
   [
    "Arthralgia",
    5710
   ],
   [
    "Rash",
    5581
   ],
   [
    "Product Use Issue",
    5422
   ],
   [
    "Condition Aggravated",
    5194
   ],
   [
    "Headache",
    5152
   ],
   [
    "Infusion Related Reaction",
    5141
   ],
   [
    "Rheumatoid Arthritis",
    4833
   ],
   [
    "Joint Swelling",
    4708
   ]
  ],
  "by_year": {
   "2019": 10254,
   "2020": 13326,
   "2021": 7744,
   "2022": 9893,
   "2023": 10033,
   "2024": 9232,
   "2025": 7209,
   "2026": 2648
  },
  "by_year_primary": {
   "2019": 10251,
   "2020": 13326,
   "2021": 7742,
   "2022": 9889,
   "2023": 10022,
   "2024": 9226,
   "2025": 7204,
   "2026": 2648
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 12,
  "nda": 0,
  "anda": 0,
  "first_approval": "20090925",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD BIOPHARMA INC.",
   "ALVOTECH USA INC",
   "AMGEN INC",
   "BIO-THERA SOLUTIONS LTD",
   "BIOCON BIOLOGICS INC",
   "CELLTRION, INC.",
   "CENTOCOR ORTHO BIOTECH INC",
   "FRESENIUS KABI USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/25/2009"
 },
 "trials": {
  "total": 266,
  "completed": 149,
  "terminated": 26,
  "with_results": 81,
  "industry": 153,
  "phase3": 71,
  "results_share": 0.5436241610738255,
  "terminated_share": 0.09774436090225563
 },
 "pubmed": {
  "rct": 150,
  "meta": 56,
  "recent_rct": 57,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1971435.74,
  "records": 44359,
  "by_name": [
   [
    "Stelara",
    1961062.34
   ],
   [
    "Yesintek",
    10373.4
   ]
  ],
  "names_checked": [
   "ustekinumab",
   "Stelara",
   "Imuldosa",
   "Otulfi",
   "Pyzchiva",
   "Selarsdi",
   "Starjemza",
   "Steqeyma",
   "Wezlana",
   "Yesintek"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 132865,
  "beneficiaries": 24754,
  "spend": 3378017374.1,
  "by_brand": [
   {
    "brand": "Stelara",
    "claims": 132865,
    "per_claim": 25424.433629,
    "is_generic": false
   }
  ],
  "per_claim": 25424.43362887141
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ustekinumab",
  "matched": "ustekinumab",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 19078,
  "fills": 132865,
  "per_million": 143589.35761863546,
  "ratio": 51.85697480500492,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 80,
   "letter": "B",
   "why": [
    "143,589 FDA reports naming it as the suspect drug per million Medicare fills, 51.9x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "150 randomized trials and 56 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "'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": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,971,436 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product dose omission issue, 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 anakinra, basiliximab, bimekizumab? 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}