{
 "query": "pegcetacoplan",
 "ingredient": "pegcetacoplan",
 "slug": "pegcetacoplan",
 "rxcui": "2557372",
 "brands": [
  "Empaveli",
  "Syfovre"
 ],
 "names": [
  "pegcetacoplan"
 ],
 "classes": [
  {
   "id": "L04AJ",
   "name": "Complement inhibitors"
  }
 ],
 "alternatives": [
  "avacopan",
  "crovalimab",
  "danicopan",
  "eculizumab",
  "iptacopan",
  "pozelimab",
  "ravulizumab",
  "sutimlimab",
  "vilobelimab",
  "zilucoplan"
 ],
 "label": {
  "route_mode": "INTRAVITREAL",
  "route_counts": {
   "INTRAVITREAL": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). ( 1 )",
  "contraindications": "Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SYFOVRE is contraindicated in patients with ocular or periocular infections [see Warnings and Precautions (5.1) ] . 4.2 Active Intraocular Inflammation SYFOVRE is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity SYFOVRE is contraindicated in patients with hypersensitivity to pegcetacoplan or to any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred in patients treated with SYFOVRE [see Adverse Reactions (6.2) ] .",
  "warnings_and_cautions": "Endophthalmitis and Retinal Detachments ( 5.1 ) Retinal Vasculitis and/or Retinal Vascular Occlusion ( 5.2 ) Neovascular AMD ( 5.3 ) Intraocular inflammation ( 5.4 ) Increased Intraocular Pressure ( 5.5 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection technique must always be used when administering SYFOVRE in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] . Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2) ] . Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without del...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular and periocular infections [see Contraindications (4.1) ] Active intraocular inflammation [see Contraindications (4.2) ] Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2) ] Neovascular AMD [see Warnings and Precautions (5.3) ] Intraocular inflammation [see Warnings and Precautions (5.4) ] Increased intraocular pressure [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence \u22655%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apellis Pharmaceuticals, Inc. at 1-833-866-3346 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 ref...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration, Preparation for Administration ( 2.3 ) 7/2025 Contraindications, Hypersensitivity ( 4.3 ) 12/2024",
  "information_for_patients": "Advise patients that following SYFOVRE administration, patients are at risk of developing endophthalmitis, retinal detachments, retinal vasculitis with or without retinal vascular occlusion and neovascular AMD. If the eye becomes red, sensitive to light, painful, or if a patient develops any change in vision such as flashing lights, blurred vision or metamorphopsia, instruct the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Patients may experience temporary visual disturbances associated either with the intravitreal injection with SYFOVRE or the eye examination [see Adverse Reactions (6.1) ] . Advise patients not to drive or use machinery until visual function has recovered sufficiently.",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of SYFOVRE were assessed in two multi-center, randomized, sham-controlled studies in patients with GA (atrophic nonexudative age-related macular degeneration), with or without subfoveal involvement, secondary to AMD in a total of 1258 randomized patients (SYFOVRE 839 patients, sham 419 patients). Studies OAKS (APL2-304; NCT03525613) and DERBY (APL2-303; NCT03525600) were 24 months in duration, in which patients received treatment for the entire length of the study. Patient ages ranged from 60 to 100 years with a mean of 78.7 years. Mean (standard deviation) total area of GA lesions(s) at baseline in the study eye (in mm 2 ) were 8.23 (3.83) and 8.29 (4.11) for OAKS and DERBY respectively. In each study, patients were randomly assigned in a 2:2:1:1 ratio to 1 of 4 dosing regimens: 1) SYFOVRE administered at 15 mg/0.1 mL monthly; 2) SYFOVRE administered at 15 mg/0.1 mL every other month; 3) sham administered monthly; 4) sham administered every other month. In OAKS, 31% of patients in the monthly group, 21% of patients in the every other month and 25% of the patients assigned to sham discontinued treatment prior to Month 24. In DERBY, 29% of patients in the mon...",
  "brand_name": "Syfovre",
  "manufacturer": "Apellis Pharmaceuticals, Inc.",
  "application_number": "NDA217171",
  "pharm_class_epc": [
   "Complement Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVITREAL"
  ],
  "effective_time": "20250916",
  "set_id": "b4434e61-9ec9-4e0e-bd60-45aaa0a87e64",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 1780,
  "serious": 1181,
  "death": 103,
  "hospitalization": 324,
  "primary_suspect": 1779,
  "top_reactions": [
   [
    "Fatigue",
    159
   ],
   [
    "Off Label Use",
    144
   ],
   [
    "Visual Impairment",
    137
   ],
   [
    "Haemoglobin Decreased",
    124
   ],
   [
    "Vitreous Floaters",
    112
   ],
   [
    "Haemolysis",
    107
   ],
   [
    "Breakthrough Haemolysis",
    91
   ],
   [
    "Headache",
    87
   ],
   [
    "Uveitis",
    79
   ],
   [
    "Vitritis",
    73
   ],
   [
    "Drug Ineffective",
    69
   ],
   [
    "Product Dose Omission Issue",
    67
   ],
   [
    "Eye Inflammation",
    66
   ],
   [
    "Choroidal Neovascularisation",
    64
   ],
   [
    "Vision Blurred",
    63
   ]
  ],
  "by_year": {
   "2021": 23,
   "2022": 56,
   "2023": 296,
   "2024": 786,
   "2025": 399,
   "2026": 220
  },
  "by_year_primary": {
   "2021": 23,
   "2022": 56,
   "2023": 296,
   "2024": 786,
   "2025": 399,
   "2026": 219
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 2,
  "anda": 0,
  "first_approval": "20210514",
  "rems": true,
  "rems_last": "20241007",
  "labeling_supplements": 5,
  "labeling_recent": 5,
  "sponsors": [
   "APELLIS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/14/2021"
 },
 "trials": {
  "total": 36,
  "completed": 17,
  "terminated": 4,
  "with_results": 15,
  "industry": 33,
  "phase3": 12,
  "results_share": 0.8823529411764706,
  "terminated_share": 0.1111111111111111
 },
 "pubmed": {
  "rct": 29,
  "meta": 2,
  "recent_rct": 28,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2461702.9000000004,
  "records": 7918,
  "by_name": [
   [
    "Syfovre",
    2288393.7
   ],
   [
    "Empaveli",
    173309.2
   ]
  ],
  "names_checked": [
   "pegcetacoplan",
   "Empaveli",
   "Syfovre"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 704,
  "beneficiaries": 71,
  "spend": 28564239.48,
  "by_brand": [
   {
    "brand": "Empaveli",
    "claims": 704,
    "per_claim": 40574.203807,
    "is_generic": false
   }
  ],
  "per_claim": 40574.20380681818
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "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": 38,
   "letter": "F",
   "why": [
    "29 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 67,
   "letter": "C",
   "why": [
    "No recalls on record since 2016",
    "REMS program in force (-10)",
    "5 label changes approved since 2021: the safety story is still moving (-8)",
    "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 $2,461,703 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)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are fatigue, visual impairment, haemoglobin decreased. 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 avacopan, crovalimab, danicopan? 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.)"
 ]
}