{
 "query": "atogepant",
 "ingredient": "atogepant",
 "slug": "atogepant",
 "rxcui": "2571813",
 "brands": [
  "Qulipta"
 ],
 "names": [
  "atogepant"
 ],
 "classes": [
  {
   "id": "N02CD",
   "name": "Calcitonin gene-related peptide (CGRP) antagonists"
  }
 ],
 "alternatives": [
  "eptinezumab",
  "erenumab",
  "fremanezumab",
  "galcanezumab",
  "rimegepant",
  "ubrogepant",
  "zavegepant"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the preventive treatment of migraine in adults. QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 )",
  "contraindications": "is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions ( 5.1 )] . Patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA. ( 4 )",
  "warnings_and_cautions": "Hypersensitivity Reactions: If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud\u2019s phenomenon: New-onset or worsening of pre-existing Raynaud\u2019s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA [see Adverse Reactions ( 6.2 )] . Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy [see Contraindications ( 4 )] . 5. 2 Hyper tension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including QULIPTA, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud\u2019s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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. The safety of QULIPTA was evaluated in 2657 patients with migraine who received at least one dose of QULIPTA. Of these, 1225 patients were exposed to QULIPTA for at least 6 months, and 826 patients were exposed for 12 months. In the 12-week, placebo-controlled clinical studies (Studies 1, 2, and 3), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 pati...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.2 ) 9/2025 Warnings and Precautions ( 5.2 , 5.3 ) 3/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with QULIPTA. Advise patients to discontinue QULIPTA and seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] . Hypertension Inform patients that hypertension can develop or pre-existing hypertension can worsen with QULIPTA, and that they should contact their healthcare providers if they experience elevation in their blood pressure [see Warnings and Precautions ( 5.2 )] . Raynaud\u2019s Phenomenon Inform patients that Raynaud\u2019s phenomenon can develop or worsen with QULIPTA. Advise patients to discontinue QULIPTA and contact their healthcare provider if they experience signs or symptoms of Raynaud\u2019s phenomenon [see Warnings and Precautions ( 5.3 )] . Drug Interactions Inform patients that QULIPTA may interact with certain other drugs, and that dosage modifications of QULIPTA may be recommended when used with some other drugs. Advise patients to report to their healthcare provider the use ...",
  "spl_medguide": "",
  "clinical_studies": "Figure 1: Change from Baseline in Monthly Migraine Days in Study 1 Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 1 Diagram Description automatically generated Chart, bar chart Description automatically generated Figure 5: Change from Baseline in Monthly Migraine Days in Study 3 Figure 6: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 3 14.1 Episodic Migraine The efficacy of QULIPTA for the preventive treatment of episodic migraine in adults was demonstrated in two randomized, multicenter, double-blind, placebo-controlled studies (Study 1 and Study 2). The studies enrolled patients with at least a 1-year history of migraine with or without aura, according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria. In Study 1 (NCT03777059), 910 patients were randomized 1:1:1:1 to receive QULIPTA 10 mg (N = 222), QULIPTA 30 mg (N = 230), QULIPTA 60 mg (N = 235), or placebo (N = 223), once daily for 12 weeks. In Study 2 (NCT02848326), 652 patients were randomized 1:2:2:2 to receive QULIPTA 10 mg (N = 94), QULIPTA 30 mg (N = 185), QULIPTA 60 mg (N = 187)...",
  "brand_name": "Qulipta",
  "manufacturer": "AbbVie Inc.",
  "application_number": "NDA215206",
  "pharm_class_epc": [
   "Calcitonin Gene-related Peptide Receptor Antagonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250930",
  "set_id": "8c8ab8f4-32bd-497a-befa-70c8a51d8d52",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 6565,
  "serious": 2342,
  "death": 75,
  "hospitalization": 588,
  "primary_suspect": 6558,
  "top_reactions": [
   [
    "Migraine",
    1164
   ],
   [
    "Drug Ineffective",
    792
   ],
   [
    "Headache",
    642
   ],
   [
    "Nausea",
    605
   ],
   [
    "Constipation",
    453
   ],
   [
    "Fatigue",
    425
   ],
   [
    "Dizziness",
    265
   ],
   [
    "Therapy Interrupted",
    197
   ],
   [
    "Off Label Use",
    175
   ],
   [
    "Pain",
    173
   ],
   [
    "Vomiting",
    173
   ],
   [
    "Decreased Appetite",
    171
   ],
   [
    "Therapeutic Product Effect Incomplete",
    151
   ],
   [
    "Weight Decreased",
    151
   ],
   [
    "Anxiety",
    145
   ]
  ],
  "by_year": {
   "2019": 3,
   "2020": 8,
   "2021": 28,
   "2022": 1687,
   "2023": 1714,
   "2024": 998,
   "2025": 1367,
   "2026": 758
  },
  "by_year_primary": {
   "2019": 3,
   "2020": 8,
   "2021": 28,
   "2022": 1686,
   "2023": 1713,
   "2024": 998,
   "2025": 1367,
   "2026": 753
  }
 },
 "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": "20210928",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 4,
  "sponsors": [
   "ABBVIE"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/28/2021"
 },
 "trials": {
  "total": 36,
  "completed": 19,
  "terminated": 0,
  "with_results": 12,
  "industry": 27,
  "phase3": 17,
  "results_share": 0.631578947368421,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 22,
  "meta": 7,
  "recent_rct": 21,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 8093271.39,
  "records": 180687,
  "by_name": [
   [
    "Qulipta",
    8093271.39
   ]
  ],
  "names_checked": [
   "atogepant",
   "Qulipta"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 209816,
  "beneficiaries": 45046,
  "spend": 260307143.86,
  "by_brand": [
   {
    "brand": "Qulipta",
    "claims": 209816,
    "per_claim": 1240.6448691,
    "is_generic": false
   }
  ],
  "per_claim": 1240.6448691234225
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3118,
  "fills": 209816,
  "per_million": 14860.639798680748,
  "ratio": 5.366886769374519,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "14,861 FDA reports naming it as the suspect drug per million Medicare fills, 5.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 42,
   "letter": "F",
   "why": [
    "22 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "4 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 $8,093,271 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)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are migraine, headache, nausea. How would we recognize and handle those?",
  "Why this one over eptinezumab, erenumab, fremanezumab? 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.)"
 ]
}