{
 "query": "risankizumab",
 "ingredient": "risankizumab",
 "slug": "risankizumab",
 "rxcui": "2166040",
 "brands": [],
 "names": [
  "risankizumab"
 ],
 "classes": [
  {
   "id": "L04AC",
   "name": "Interleukin inhibitors"
  }
 ],
 "alternatives": [
  "anakinra",
  "basiliximab",
  "bimekizumab",
  "brodalumab",
  "canakinumab",
  "daclizumab",
  "guselkumab",
  "ixekizumab",
  "mirikizumab",
  "rilonacept",
  "sarilumab",
  "satralizumab",
  "secukinumab",
  "siltuximab",
  "spesolimab",
  "tildrakizumab",
  "tocilizumab",
  "ustekinumab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 ) 1.1 Plaque Psoriasis SKYRIZI \u00ae is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older. 1.3 Crohn\u2019s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.",
  "contraindications": "is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] . SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients ( 4 )",
  "warnings_and_cautions": "Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer SKYRIZI until the infection resolves. ( 5.2 ) Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI. ( 5.3 ) Hepatotoxicity: Drug-induced liver injury during induction treatment of inflammatory bowel disease has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management. ( 5.4 ) Immunizations: Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1 )]. 5. 2 Infections SKYRIZI may increase the risk of infections [see Adverse Reactions ( 6.1 )] . Treatment with SKYRIZI should n...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (\u2265 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn\u2019s Disease (>3%): \u25e6 Induction : upper respiratory infections, headache, and arthralgia. ( 6.1 ) \u25e6 Maintenance : arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (\u22653%): \u25e6 Induction : arthralgia. ( 6.1 ) \u25e6 Maintenance : arthralgia, pyrexia, injection site reactions, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 drug reaction rates observed in the clinical trials of a drug cannot be directly comp...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.1 , 1.2 ) 6/2026 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 , 2.8 ) 6/2026",
  "information_for_patients": "Advise patients and/or caregivers to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Hypersensitivity Reactions Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. Infections Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions ( 5.2 )] . Hepatotoxicity Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions ( 5.4 )] . Immunizations Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or af...",
  "spl_medguide": "Medication Guide SKYRIZI \u00ae (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use What is the most important information I should know about SKYRIZI? SKYRIZI may cause serious side effects, including: Serious allergic reactions. Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: \u25cf fainting, dizziness, feeling lightheaded (low blood pressure) \u25cf chest tightness \u25cf swelling of your face, eyelids, lips, mouth, tongue, or throat \u25cf skin rash, hives \u25cf trouble breathing or throat tightness \u25cf itching Infections. SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: \u25cf fever,...",
  "clinical_studies": "Figure 1. Percent of Adult Subjects with Active Psoriatic Arthritis Achieving ACR20 Responses in Trial PsA-1 through Week 24 14.1 Clinical Trials in Subjects with Moderate-to-Severe Plaque Psoriasis Adults with Moderate-to-Severe Plaque Psoriasis Four multicenter, randomized, double-blind trials [PsO-1 (NCT02684370), PsO-2 (NCT02684357), PsO-3 (NCT02672852), and PsO-4 (NCT02694523)] enrolled 2,109 subjects 18 years of age and older with moderate-to-severe plaque psoriasis who had a body surface area (BSA) involvement of \u226510%, a static Physician\u2019s Global Assessment (sPGA) score of \u22653 (\u201cmoderate\u201d) in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score \u226512. Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20%. Baseline sPGA score was 4 (\u201csevere\u201d) in 19% of subjects. A total of 10% of trial subjects had a history of diagnosed psoriatic arthritis. Across all trials, 38% of subjects had received prior phototherapy, 48% had received prior non-biologic systemic therapy, and 42% had received prior biologic therapy for the treatment of psorias...",
  "brand_name": "Skyrizi",
  "manufacturer": "AbbVie Inc.",
  "application_number": "BLA761105",
  "pharm_class_epc": [
   "Interleukin-23 Antagonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS",
   "INTRAVENOUS"
  ],
  "effective_time": "20260615",
  "set_id": "7148c8eb-b39e-e20a-6494-a6df82392858",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4175,
  "serious": 1582,
  "death": 64,
  "hospitalization": 652,
  "primary_suspect": 4175,
  "top_reactions": [
   [
    "Product Storage Error",
    907
   ],
   [
    "Drug Ineffective",
    282
   ],
   [
    "Off Label Use",
    186
   ],
   [
    "Psoriasis",
    183
   ],
   [
    "Product Temperature Excursion Issue",
    178
   ],
   [
    "Crohn^S Disease",
    147
   ],
   [
    "Arthralgia",
    134
   ],
   [
    "Diarrhoea",
    100
   ],
   [
    "Fatigue",
    97
   ],
   [
    "Headache",
    88
   ],
   [
    "Abdominal Pain",
    80
   ],
   [
    "Pruritus",
    80
   ],
   [
    "Rash",
    79
   ],
   [
    "Therapeutic Product Effect Incomplete",
    72
   ],
   [
    "Product Quality Issue",
    71
   ]
  ],
  "by_year": {
   "2019": 26,
   "2020": 55,
   "2021": 101,
   "2022": 124,
   "2023": 189,
   "2024": 792,
   "2025": 1963,
   "2026": 919
  },
  "by_year_primary": {
   "2019": 26,
   "2020": 55,
   "2021": 101,
   "2022": 124,
   "2023": 189,
   "2024": 792,
   "2025": 1963,
   "2026": 919
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 121,
  "completed": 65,
  "terminated": 2,
  "with_results": 34,
  "industry": 96,
  "phase3": 36,
  "results_share": 0.5230769230769231,
  "terminated_share": 0.01652892561983471
 },
 "pubmed": {
  "rct": 58,
  "meta": 9,
  "recent_rct": 43,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "risankizumab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "58 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-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": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product storage error, psoriasis. 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?",
  "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.)"
 ]
}