{
 "query": "ranibizumab",
 "ingredient": "ranibizumab",
 "slug": "ranibizumab",
 "rxcui": "595060",
 "brands": [
  "Lucentis",
  "Susvimo"
 ],
 "names": [
  "ranibizumab"
 ],
 "classes": [
  {
   "id": "S01LA",
   "name": "Antineovascularisation agents"
  }
 ],
 "alternatives": [
  "aflibercept",
  "bevacizumab",
  "brolucizumab",
  "faricimab",
  "pegaptanib",
  "verteporfin"
 ],
 "label": {
  "route_mode": "INTRAVITREAL",
  "route_counts": {
   "INTRAVITREAL": 6
  },
  "boxed_warning": "WARNING: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. [see Contraindications (4.1) , Warnings and Precautions (5.1) ] . WARNING: ENDOPHTHALMITIS See full prescribing information for complete boxed warning. The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.",
  "indications_and_usage": "(ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.1 ). Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ). Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.3 ). 1.1 Neovascular (wet) Age-related Macular Degeneration (AMD) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication. 1.2 Diabetic Macular Edema (DME) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication. 1.3 Diabetic Retinopathy (DR) SUSVIMO (ranibiz...",
  "contraindications": "Ocular or periocular infections ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection).",
  "warnings_and_cautions": "The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs. Patients should be instructed to report any signs or symptoms that could be associated with these events without delay. In some cases, these events can present asymptomatically. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion, and refill-exchange procedures to permit early medical or surgical intervention as necessary. Special precautions need to be taken when handling SUSVIMO components [see How Supplied/Storage and Handling (16.3) ]. The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical manageme...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis [see Warnings and Precautions (5.1) ] Rhegmatogenous Retinal Detachment [see Warnings and Precautions (5.2) ] Implant Dislocation [see Warnings and Precautions (5.3) ] Septum Dislodgement [see Warnings and Precautions (5.4) ] Vitreous Hemorrhage [see Warnings and Precautions (5.5) ] Conjunctival Erosion or Retraction [see Warnings and Precautions (5.6) ] Conjunctival Bleb [see Warnings and Precautions (5.7) ] Postoperative Decrease in Visual Acuity [see Warnings and Precautions (5.8) ] The most common adverse reactions (\u2265 10%) were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract and vitreous hemorrhage. ( 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 one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observe...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Diabetic Macular Edema (DME) ( 1.2 ) 2/2025 Indications and Usage, Diabetic Retinopathy (DR) ( 1.3 ) 5/2025 Dosage and Administration ( 2.3 , 2.9 , 2.10 ) 5/2025 Warnings and Precautions ( 5.1 , 5.5 , 5.6 , 5.7 , 5.8 ) 5/2025 Warnings and Precautions ( 5.9 ) 9/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Advise patients on the following after the implant insertion procedure: Positioning: Keep head above shoulder level for the rest of the day. Sleep with head on 3 or more pillows during the day and the night after surgery. How to care for the treated eye after the procedure: Do not remove the eye shield until they are instructed to do so by their healthcare provider. At bedtime, continue to wear the eye shield for at least 7 nights following the implant surgery. Administer all post-operative eye medications as directed by their healthcare provider. Do not push on the eye, rub the eye, or touch the area of the eye where the implant is located (underneath the eyelid in the upper and outer part of the eye) for 30 days following the implant insertion. Do not participate in strenuous activities until 1-month after the implant insertion or after discussion with their healthcare provider. Magnetic Resonance (MR) Conditional information: The SUSVIMO implant is MR conditional. Inform their healthcare provider that they have SUSVIMO implanted in their eye and show their healthcare provider the SUSVIMO implant c...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 5/2025 MEDICATION GUIDE SUSVIMO \u00ae (suss-VIH-moh) (ranibizumab injection) for intravitreal use via SUSVIMO ocular implant What is the most important information I should know about SUSVIMO? SUSVIMO (ranibizumab injection) is delivered into the eye using the SUSVIMO implant. The SUSVIMO implant and the procedures to insert, fill, refill and remove the eye (ocular) implant can cause serious side effects including: an eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye including blindness. Call your healthcare provider right away if you have increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye. Endophthalmitis requires urgent (same day) medical or surgical treatment. a missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye which may result in exposure of the implant. Call your healthcare provider right away if you have a sudden feeling that somet...",
  "clinical_studies": "14.1 Neovascular (wet) Age-related Macular Degeneration (AMD) The clinical efficacy and safety of SUSVIMO (ranibizumab injection) was assessed in a randomized, visual assessor-masked, active treatment-controlled study (Archway-NCT03677934) in patients with AMD. A total of 415 patients (248 in the SUSVIMO arm and 167 in the intravitreal ranibizumab arm) were enrolled and treated in this study. Patients were diagnosed with AMD within the 9 months prior to screening and received \u2265 3 doses of anti-VEGF intravitreal agents in the study eye within the last 6 months prior to screening. Each patient was required to have demonstrated a response to an anti-VEGF intravitreal agent prior to randomization. Patients were randomized in a 3:2 ratio to receive continuous delivery of SUSVIMO (ranibizumab injection) via the SUSVIMO implant every 24 weeks or 0.5 mg intravitreal ranibizumab injections every 4 weeks. For patients randomized to the SUSVIMO arm, supplemental treatment with 0.5 mg intravitreal ranibizumab injections was available at Weeks 16, 20, 40, 44, 64, 68, 88, and 92, if needed. In the first 24 weeks, 1.6% of patients assessed for supplemental treatment received 1 or more supplementa...",
  "brand_name": "Susvimo",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA761197",
  "pharm_class_epc": [
   "Vascular Endothelial Growth Factor Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVITREAL"
  ],
  "effective_time": "20251121",
  "set_id": "9c6d9e2a-9a77-4d11-b692-de87cfde3444",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16028,
  "serious": 12430,
  "death": 2661,
  "hospitalization": 2285,
  "primary_suspect": 16027,
  "top_reactions": [
   [
    "Death",
    2285
   ],
   [
    "Off Label Use",
    1642
   ],
   [
    "Visual Acuity Reduced",
    1355
   ],
   [
    "Visual Impairment",
    1254
   ],
   [
    "No Adverse Event",
    1051
   ],
   [
    "Drug Ineffective",
    891
   ],
   [
    "Blindness",
    793
   ],
   [
    "Vision Blurred",
    733
   ],
   [
    "Eye Pain",
    650
   ],
   [
    "Endophthalmitis",
    569
   ],
   [
    "Eye Haemorrhage",
    536
   ],
   [
    "Cerebrovascular Accident",
    511
   ],
   [
    "Macular Oedema",
    482
   ],
   [
    "Vitreous Floaters",
    480
   ],
   [
    "Retinal Haemorrhage",
    445
   ]
  ],
  "by_year": {
   "2019": 1308,
   "2020": 1275,
   "2021": 1048,
   "2022": 876,
   "2023": 765,
   "2024": 1259,
   "2025": 507,
   "2026": 209
  },
  "by_year_primary": {
   "2019": 1308,
   "2020": 1275,
   "2021": 1048,
   "2022": 876,
   "2023": 765,
   "2024": 1259,
   "2025": 507,
   "2026": 208
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20221018",
   "reason": "Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.",
   "firm": "Genentech Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 2,
  "nda": 0,
  "anda": 0,
  "first_approval": "20060630",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH",
   "GENENTECH INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/30/2006"
 },
 "trials": {
  "total": 652,
  "completed": 447,
  "terminated": 72,
  "with_results": 198,
  "industry": 392,
  "phase3": 153,
  "results_share": 0.4429530201342282,
  "terminated_share": 0.11042944785276074
 },
 "pubmed": {
  "rct": 421,
  "meta": 74,
  "recent_rct": 74,
  "cochrane": [
   {
    "pmid": "25220133",
    "title": "Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 392063.23000000004,
  "records": 788,
  "by_name": [
   [
    "Susvimo",
    380156.71
   ],
   [
    "Lucentis",
    11906.52
   ]
  ],
  "names_checked": [
   "ranibizumab",
   "Lucentis",
   "Susvimo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1203,
  "beneficiaries": 332,
  "spend": 2630670.6,
  "by_brand": [
   {
    "brand": "Lucentis",
    "claims": 1203,
    "per_claim": 2186.7586035,
    "is_generic": false
   }
  ],
  "per_claim": 2186.758603491272
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "ranibizumab",
  "matched": "ranibizumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 61,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "421 randomized trials and 74 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 44% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III (-1)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $392,063 tied to this drug last year (-15)",
    "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": [
  "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 death, visual acuity reduced, visual impairment. 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?",
  "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.)"
 ]
}