{
 "query": "faricimab",
 "ingredient": "faricimab",
 "slug": "faricimab",
 "rxcui": "2591519",
 "brands": [
  "Vabysmo"
 ],
 "names": [
  "faricimab"
 ],
 "classes": [
  {
   "id": "S01LA",
   "name": "Antineovascularisation agents"
  }
 ],
 "alternatives": [
  "aflibercept",
  "bevacizumab",
  "brolucizumab",
  "pegaptanib",
  "ranibizumab",
  "verteporfin"
 ],
 "label": {
  "route_mode": "INTRAVITREAL",
  "route_counts": {
   "INTRAVITREAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 ) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO)",
  "contraindications": "Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.",
  "warnings_and_cautions": "Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition. ( 5.3 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including Vabysmo, have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any signs or symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Dosage and Administration (2.6) and Patient Counseling Information (17) ]. 5.2 Increase in Intraocular Pressure Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO [see Adverse Reactions (6.1) ]. IOP...",
  "warnings": "",
  "adverse_reactions": "The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.4) ] The most common adverse reactions (\u2265 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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 other clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to VABYSMO in 2,567 patients, which constituted the safety population in six Phase 3 studies [see Clinical Studies (14.1 , 14.2 , 14.3) ] . Tab...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration, Macular Edema Following Retinal Vein Occlusion (RVO) ( 2.4 ) 4/2026",
  "information_for_patients": "Advise patients that in the days following VABYSMO administration, patients are at risk of developing endophthalmitis, retinal detachment, intraocular inflammation and retinal vasculitis with or without retinal vascular occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5) ] . Patients may experience temporary visual disturbances after an intravitreal injection with VABYSMO and the associated eye examinations [see Adverse Reactions (6) ] . Advise patients not to drive or use machinery until visual function has recovered sufficiently.",
  "spl_medguide": "",
  "clinical_studies": "14.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) The safety and efficacy of VABYSMO were assessed in two randomized, multi-center, double-masked, active comparator-controlled, 2-year studies (TENAYA \u2013 NCT03823287 and LUCERNE \u2013 NCT03823300) in patients with nAMD. A total of 1,329 newly diagnosed, treatment-na\u00efve patients were enrolled in these studies, and 664 patients received at least one dose of VABYSMO. Patient ages ranged from 50 to 99 with a mean of 75.9 years. The studies were identically designed two year studies. Patients were randomized in a 1:1 ratio to one of two treatment arms: 1) aflibercept 2 mg administered fixed every 8 weeks (Q8W) after three initial monthly doses; and VABYSMO 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 \u00b1 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to determine whether to give a 6 mg (0.05 mL of 120 mg/mL solution) dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; (also referred to as Q16W dosing); 2) Weeks 24, 36 and 48 (also referred to...",
  "brand_name": "VABYSMO",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA761235",
  "pharm_class_epc": [],
  "route": [
   "INTRAVITREAL"
  ],
  "effective_time": "20260415",
  "set_id": "04cc9ef7-c02a-4e92-a655-0062674e8487",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 570,
  "serious": 439,
  "death": 29,
  "hospitalization": 123,
  "primary_suspect": 570,
  "top_reactions": [
   [
    "Off Label Use",
    74
   ],
   [
    "No Adverse Event",
    36
   ],
   [
    "Retinal Haemorrhage",
    35
   ],
   [
    "Iridocyclitis",
    34
   ],
   [
    "Uveitis",
    34
   ],
   [
    "Drug Ineffective",
    30
   ],
   [
    "Vitritis",
    27
   ],
   [
    "Eye Inflammation",
    24
   ],
   [
    "Death",
    21
   ],
   [
    "Cataract",
    19
   ],
   [
    "Visual Acuity Reduced",
    19
   ],
   [
    "Neovascular Age-Related Macular Degeneration",
    17
   ],
   [
    "Blindness",
    16
   ],
   [
    "Diabetic Retinopathy",
    16
   ],
   [
    "Retinal Pigment Epithelial Tear",
    15
   ]
  ],
  "by_year": {
   "2019": 3,
   "2020": 4,
   "2021": 12,
   "2022": 67,
   "2023": 77,
   "2024": 163,
   "2025": 129,
   "2026": 115
  },
  "by_year_primary": {
   "2019": 3,
   "2020": 4,
   "2021": 12,
   "2022": 67,
   "2023": 77,
   "2024": 163,
   "2025": 129,
   "2026": 115
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20220128",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/28/2022"
 },
 "trials": {
  "total": 60,
  "completed": 27,
  "terminated": 0,
  "with_results": 13,
  "industry": 30,
  "phase3": 16,
  "results_share": 0.48148148148148145,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 27,
  "meta": 16,
  "recent_rct": 24,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2141900.26,
  "records": 8252,
  "by_name": [
   [
    "Vabysmo",
    2141900.26
   ]
  ],
  "names_checked": [
   "faricimab",
   "Vabysmo"
  ],
  "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 (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "27 randomized trials and 16 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 48% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "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 $2,141,900 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)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are no adverse event, retinal haemorrhage, iridocyclitis. 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 aflibercept, bevacizumab, brolucizumab? 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.)"
 ]
}