{
 "query": "abrocitinib",
 "ingredient": "abrocitinib",
 "slug": "abrocitinib",
 "rxcui": "2591476",
 "brands": [
  "Cibinqo"
 ],
 "names": [
  "abrocitinib"
 ],
 "classes": [
  {
   "id": "D11AH",
   "name": "Agents for dermatitis, excluding corticosteroids"
  }
 ],
 "alternatives": [
  "alitretinoin",
  "crisaborole",
  "cromolyn",
  "delgocitinib",
  "dupilumab",
  "lebrikizumab",
  "nemolizumab",
  "pimecrolimus",
  "ruxolitinib",
  "tacrolimus",
  "tralokinumab"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. \u2022 Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. ( 5.1 ) \u2022 Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients. ( 5.2 ) \u2022 Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) \u2022 MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another J...",
  "indications_and_usage": "is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. ( 1 ) Limitation of Use : CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.",
  "contraindications": "is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (\u226481 mg daily), during the first 3 months of treatment [see Warnings and Precautions (5.7) , Drug Interactions (7.2) , and Clinical Pharmacology (12.2) ]. Antiplatelet therapies except for low-dose aspirin (\u226481 mg daily), during the first 3 months of treatment. ( 4 )",
  "warnings_and_cautions": "\u2022 Hypoglycemia in Patients with Diabetes : Consider increased monitoring of blood glucose; advise diabetic patients to notify their healthcare provider if they develop signs and symptoms of hypoglycemia. ( 5.6 ) \u2022 Laboratory Abnormalities : Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. ( 5.7 ) \u2022 Immunizations : Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment. ( 5.8 ) 5.1 Serious Infections The most frequent serious infections reported in clinical studies with CIBINQO for atopic dermatitis were herpes simplex, herpes zoster, and pneumonia [see Adverse Reactions (6.1) ] . Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. Avoid use of CIBINQO in patients with active, serious infection including localized infections. Consider the risks and benefits of treatment prior to initiating CIBINQO in patients: \u2022 with chronic or recurrent infection \u2022 who have been exposed to tuberculosis \u2022 with a history...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Serious Infections [see Warnings and Precautions (5.1) ] \u2022 Mortality [see Warnings and Precautions (5.2) ] \u2022 Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] \u2022 Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4) ] \u2022 Thrombosis [see Warnings and Precautions (5.5) ] \u2022 Laboratory Abnormalities [see Warnings and Precautions (5.7) ] Most common adverse events (\u22651% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact. ( 6.1 ) Most common adverse reactions (\u22651% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.6 ) 6/2026 Dosage and Administration ( 2.5 ) 9/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Pregnancy Registry Advise patients to report their pregnancy to 1-877-311-3770 [see Use in Specific Populations (8.1) ] . Serious Infections Inform patients that they may develop infections when taking CIBINQO. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.1) ] . Advise patients that the risk of herpes zoster is increased in patients treated with CIBINQO and some cases can be serious [see Warnings and Precautions (5.1) ] . Malignancies Inform patients that CIBINQO may increase their risk of certain cancers, including skin cancers. Periodic skin examinations are recommended while using CIBINQO. Advise patients that exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions (5.3) ] . Major Adverse Cardiovascular Events Inform patients that CIBINQO may increase their risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Approved: 9/2026 Medication Guide CIBINQO (Si BINK oh) (abrocitinib) tablets, for oral use What is the most important information I should know about CIBINQO? CIBINQO may cause serious side effects, including: 1. Serious infections CIBINQO is a medicine that affects your immune system. CIBINQO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking CIBINQO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. \u2022 Your healthcare provider should test you for TB before starting treatment with CIBINQO. \u2022 Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with CIBINQO. You should not start taking CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting CIBINQO, tell your healthcare provider if you: \u2022 are being treated for an ...",
  "clinical_studies": "The efficacy of CIBINQO as monotherapy and in combination with background topical corticosteroids was evaluated in 4 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD-2 (NCT03575871), Trial-AD-3 (NCT03720470), and Trial-AD-4 (NCT03796676)] in 1900 subjects (see Table 8). Trial-AD-1 and Trial-AD-2 enrolled adult and pediatric subjects 12 years of age and older. Trial-AD-3 enrolled only adults (\u226518 years of age) and Trial-AD-4 enrolled only pediatric subjects 12 to less than 18 years of age. The trials enrolled subjects with moderate-to-severe atopic dermatitis as defined by Investigator\u2019s Global Assessment (IGA) score \u22653, Eczema Area and Severity Index (EASI) score \u226516, body surface area (BSA) involvement \u226510%, and Peak Pruritus Numerical Rating Scale (PP-NRS) \u22654 at the baseline visit prior to randomization. Baseline Characteristics In Trial-AD-1, Trial-AD-2, and Trial-AD-3, 53% of subjects were male, 69% of subjects were white, 64% of subjects had a baseline IGA score of 3 (moderate AD), and 36% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 30. The baseline mean age was 36 years old with 8% of subjects ...",
  "brand_name": "Cibinqo",
  "manufacturer": "Pfizer Laboratories Div Pfizer Inc",
  "application_number": "NDA213871",
  "pharm_class_epc": [
   "Janus Kinase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260909",
  "set_id": "3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 3840,
  "serious": 1320,
  "death": 65,
  "hospitalization": 391,
  "primary_suspect": 3796,
  "top_reactions": [
   [
    "Drug Ineffective",
    529
   ],
   [
    "Condition Aggravated",
    363
   ],
   [
    "Off Label Use",
    320
   ],
   [
    "Pruritus",
    238
   ],
   [
    "Therapeutic Product Effect Incomplete",
    207
   ],
   [
    "Rash",
    177
   ],
   [
    "Dermatitis Atopic",
    171
   ],
   [
    "Nausea",
    159
   ],
   [
    "Headache",
    104
   ],
   [
    "Eczema",
    91
   ],
   [
    "Acne",
    88
   ],
   [
    "Fatigue",
    80
   ],
   [
    "Dizziness",
    69
   ],
   [
    "Erythema",
    63
   ],
   [
    "Dry Skin",
    59
   ]
  ],
  "by_year": {
   "2019": 2,
   "2020": 2,
   "2021": 11,
   "2022": 416,
   "2023": 1084,
   "2024": 1189,
   "2025": 965,
   "2026": 171
  },
  "by_year_primary": {
   "2019": 2,
   "2020": 2,
   "2021": 11,
   "2022": 410,
   "2023": 1073,
   "2024": 1177,
   "2025": 950,
   "2026": 171
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20220114",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 2,
  "labeling_recent": 2,
  "sponsors": [
   "PFIZER"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/14/2022"
 },
 "trials": {
  "total": 61,
  "completed": 35,
  "terminated": 2,
  "with_results": 18,
  "industry": 47,
  "phase3": 11,
  "results_share": 0.5142857142857142,
  "terminated_share": 0.03278688524590164
 },
 "pubmed": {
  "rct": 31,
  "meta": 9,
  "recent_rct": 27,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 3108573.28,
  "records": 15840,
  "by_name": [
   [
    "Cibinqo",
    3108573.28
   ]
  ],
  "names_checked": [
   "abrocitinib",
   "Cibinqo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2728,
  "beneficiaries": 536,
  "spend": 17054377.58,
  "by_brand": [
   {
    "brand": "Cibinqo",
    "claims": 2728,
    "per_claim": 6251.6046848,
    "is_generic": false
   }
  ],
  "per_claim": 6251.604684750732
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "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 (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "31 randomized trials and 9 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": 81,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $3,108,573 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)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 63,
 "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 condition aggravated, pruritus. 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 alitretinoin, crisaborole, cromolyn? 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.)"
 ]
}