{
 "query": "secukinumab",
 "ingredient": "secukinumab",
 "slug": "secukinumab",
 "rxcui": "1599788",
 "brands": [
  "Cosentyx"
 ],
 "names": [
  "secukinumab"
 ],
 "classes": [
  {
   "id": "L04AC",
   "name": "Interleukin inhibitors"
  }
 ],
 "alternatives": [
  "anakinra",
  "basiliximab",
  "bimekizumab",
  "brodalumab",
  "canakinumab",
  "daclizumab",
  "guselkumab",
  "ixekizumab",
  "mirikizumab",
  "rilonacept",
  "risankizumab",
  "sarilumab",
  "satralizumab",
  "siltuximab",
  "spesolimab",
  "tildrakizumab",
  "tocilizumab",
  "ustekinumab"
 ],
 "label": {
  "route_mode": null,
  "route_counts": {},
  "boxed_warning": "",
  "indications_and_usage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. ( 1.2 ) active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. ( 1.3 ) active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. ( 1.4 ) active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. ( 1.5 ) moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. ( 1.6 ) 1.1 Plaque Psoriasis COSENTYX \u00ae is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. 1.3 Ankylosing Spondylitis COSENTYX is indicated for th...",
  "contraindications": "COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX [see Warnings and Precautions (5.2)] . Serious hypersensitivity to secukinumab or any excipients in COSENTYX. ( 4 )",
  "warnings_and_cautions": "Infections : Serious infections have occurred. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue COSENTYX until the infection resolves. ( 5.1 ) Hypersensitivity Reactions : If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy. ( 5.2 ) Tuberculosis (TB) : Prior to initiating treatment with COSENTYX, evaluate for TB. ( 5.3 ) Inflammatory Bowel Disease (IBD) : Cases of IBD were observed in clinical trials. Exercise caution when prescribing COSENTYX to patients with IBD. ( 5.4 ) Eczematous Eruptions : Cases of severe eczematous eruptions have occurred in patients receiving COSENTYX. ( 5.5 ) Immunizations : Avoid use of live vaccines in patients treated with COSENTYX. ( 5.7 ) 5.1 Infections COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as na...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Inflammatory Bowel Disease [see Warnings and Precautions (5.4)] Eczematous Eruptions [see Warnings and Precautions (5.5)] Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 practice. Adverse Reactions in Clinical Trials of Subcutaneous COSENTYX Adverse Reactions from Clinical Trials in Adults with PsO A total of 3,430 adult subjects with PsO were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1,641 subjects were treated with COSENTYX for at least 1 year. Fou...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.3 ) 4/2026 Dosage and Administration ( 2.7 ) 4/2026 Indications and Usage ( 1.6 ) 3/2026 Dosage and Administration ( 2.10 ) 3/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that COSENTYX may lower the ability of their immune system to fight infections and that serious infections, including opportunistic infections, may occur with the use of COSENTYX. Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.1, 5.3)] . Hypersensitivity Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.2)] . Eczematous Eruptions Inform patients that skin reactions resembling eczema may occur with the use of COSENTYX. Instruct patients to seek medical advice if they develop signs or symptoms of eczema [see Warnings and Precautions (5.5)] . Risk of Hypersensitivity in Latex-Sensitive Individuals Advise latex-sensitive patients that the removal cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex, which may cause an allergic reaction in latex-s...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: August 2026 T2026-33 MEDICATION GUIDE COSENTYX \u00ae (koe-sen-tix) (secukinumab) injection, for subcutaneous or intravenous use What is the most important information I should know about COSENTYX? COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections. COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections during treatment with COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have died from these infections. Your healthcare provider should check you for TB before starting treatment with COSENTYX. 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 COSENTYX and during treatment with COSENTYX. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection. Before starting COSENTYX...",
  "clinical_studies": "14.1 Adult Plaque Psoriasis Four multicenter, randomized, double-blind, placebo-controlled trials of subcutaneous COSENTYX (Trials PsO1, PsO2, PsO3, and PsO4) enrolled 2,403 subjects (691 randomized to COSENTYX 300 mg, 692 to COSENTYX 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with PsO who had a minimum BSA involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In these studies, each 300 mg dose was administered as two injections of 150 mg. Trial PsO1 (NCT01365455) enrolled 738 subjects (245 randomized to COSENTYX 300 mg, 245 to COSENTYX 150 mg, and 248 to placebo). Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks. Subjects randomized to receive placebo that were non-responders at Week 12 were crossed over to receive COSENTYX (either 300 mg or 150 mg) at Weeks 12, 13, 14, 15, and 16 followed by the same dose every 4 weeks. All subjects were followed for up to 52 weeks following first administration of trial treatment. Trial PsO2 (NCT01358578) enrolled 1306 subjects (327 randomized ...",
  "brand_name": "COSENTYX",
  "manufacturer": "",
  "application_number": "",
  "pharm_class_epc": [],
  "route": [],
  "effective_time": "20260825",
  "set_id": "77c4b13e-7df3-42d4-81db-3d0cddb7f67a",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 161288,
  "serious": 65175,
  "death": 8649,
  "hospitalization": 22376,
  "primary_suspect": 161240,
  "top_reactions": [
   [
    "Drug Ineffective",
    29229
   ],
   [
    "Psoriasis",
    22883
   ],
   [
    "Pain",
    16694
   ],
   [
    "Arthralgia",
    14972
   ],
   [
    "Fatigue",
    10619
   ],
   [
    "Psoriatic Arthropathy",
    10217
   ],
   [
    "Malaise",
    9487
   ],
   [
    "Pruritus",
    9479
   ],
   [
    "Rash",
    9142
   ],
   [
    "Condition Aggravated",
    8531
   ],
   [
    "Diarrhoea",
    8031
   ],
   [
    "Nasopharyngitis",
    7835
   ],
   [
    "Pain In Extremity",
    7344
   ],
   [
    "Headache",
    7293
   ],
   [
    "Off Label Use",
    6787
   ]
  ],
  "by_year": {
   "2019": 21593,
   "2020": 22724,
   "2021": 17090,
   "2022": 17155,
   "2023": 17262,
   "2024": 11054,
   "2025": 9198,
   "2026": 3008
  },
  "by_year_primary": {
   "2019": 21589,
   "2020": 22719,
   "2021": 17077,
   "2022": 17151,
   "2023": 17255,
   "2024": 11050,
   "2025": 9193,
   "2026": 3004
  }
 },
 "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": "20150121",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "NOVARTIS PHARMS CORP"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/21/2015"
 },
 "trials": {
  "total": 266,
  "completed": 170,
  "terminated": 30,
  "with_results": 128,
  "industry": 207,
  "phase3": 100,
  "results_share": 0.7529411764705882,
  "terminated_share": 0.11278195488721804
 },
 "pubmed": {
  "rct": 175,
  "meta": 36,
  "recent_rct": 76,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2656654.73,
  "records": 79471,
  "by_name": [
   [
    "Cosentyx",
    2656654.73
   ]
  ],
  "names_checked": [
   "secukinumab",
   "Cosentyx"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 178351,
  "beneficiaries": 27644,
  "spend": 1562575147.71,
  "by_brand": [
   {
    "brand": "Cosentyx Sensoready (2 Pens)",
    "claims": 102445,
    "per_claim": 7980.6732744,
    "is_generic": false
   },
   {
    "brand": "Cosentyx Unoready Pen",
    "claims": 36579,
    "per_claim": 10329.962351,
    "is_generic": false
   },
   {
    "brand": "Cosentyx Sensoready Pen",
    "claims": 25412,
    "per_claim": 9770.5652471,
    "is_generic": false
   },
   {
    "brand": "Cosentyx (2 Syringes)",
    "claims": 10233,
    "per_claim": 8162.7832141,
    "is_generic": false
   },
   {
    "brand": "Cosentyx Syringe",
    "claims": 3424,
    "per_claim": 9983.2061273,
    "is_generic": false
   },
   {
    "brand": "Cosentyx",
    "claims": 258,
    "per_claim": 4393.4836822,
    "is_generic": false
   }
  ],
  "per_claim": 8761.235696519785
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23247,
  "fills": 178351,
  "per_million": 130344.09675303193,
  "ratio": 47.07347851820088,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "130,344 FDA reports naming it as the suspect drug per million Medicare fills, 47.1x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "175 randomized trials and 36 systematic reviews/meta-analyses indexed in PubMed",
    "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 $2,656,655 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": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are psoriasis, pain, arthralgia. How would we recognize and handle those?",
  "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.)"
 ]
}