{
 "query": "bevacizumab",
 "ingredient": "bevacizumab",
 "slug": "bevacizumab",
 "rxcui": "253337",
 "brands": [
  "Avastin"
 ],
 "names": [
  "bevacizumab"
 ],
 "classes": [
  {
   "id": "L01FG",
   "name": "VEGF/VEGFR (Vascular Endothelial Growth Factor / -Receptor) inhibitors"
  },
  {
   "id": "S01LA",
   "name": "Antineovascularisation agents"
  }
 ],
 "alternatives": [
  "aflibercept",
  "brolucizumab",
  "faricimab",
  "pegaptanib",
  "ramucirumab",
  "ranibizumab",
  "verteporfin"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 5,
   "INTRAVASCULAR": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : Avastin is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) Recurrent glioblastoma in adults. ( 1.3 ) Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. ( 1.5 ) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following ...",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Gastrointestinal Perforations and Fistula : Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ ( 5.1 ) Surgery and Wound Healing Complications : In patients who experience wound healing complications during Avastin treatment, withhold Avastin until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of AVASTIN after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis. ( 5.2 ) Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage ( 5.3 ) Arterial Thromboembolic Events (ATE) : Discontinue for severe ATE. ( 5.4 ) Venous Thromboembolic Events (VTE) : Discontinue for Grade 4 VTE. ( 5.5 ) Hypertension : Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy. ( 5.6 ) Poste...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1) ] . Surgery and Wound Healing Complications [see Warnings and Precautions (5.2) ]. Hemorrhage [see Warnings and Precautions (5.3) ]. Arterial Thromboembolic Events [see Warnings and Precautions (5.4) ]. Venous Thromboembolic Events [see Warnings and Precautions (5.5) ]. Hypertension [see Warnings and Precautions (5.6) ]. Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7) ]. Renal Injury and Proteinuria [see Warnings and Precautions (5.8) ]. Infusion-Related Reactions [see Warnings and Precautions (5.9) ]. Ovarian Failure [see Warnings and Precautions (5.11) ]. Congestive Heart Failure [see Warnings and Precautions (5.12) ]. Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.1 ) 9/2022 Dosage and Administration ( 2.2 ) 9/2022 Warnings and Precautions, Infusion-Related Reactions ( 5.9 ) 9/2022",
  "information_for_patients": "Gastrointestinal Perforations and Fistulae : Avastin may increase the risk of developing gastrointestinal perforations and fistulae. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, or vomiting [ see Warnings and Precautions (5.1) ]. Surgery and Wound Healing Complications : Avastin can increase the risk of wound healing complications. Instruct patients not to undergo surgery without first discussing this potential risk with their healthcare provider [see Warnings and Precautions (5.2) ] . Hemorrhage : Avastin can increase the risk of hemorrhage. Advise patients to immediately contact their healthcare provider for signs and symptoms of serious or unusual bleeding including coughing or spitting blood [see Warnings and Precautions (5.3) ] . Arterial and Venous Thromboembolic Events : Avastin increases the risk of arterial and venous thromboembolic events. Advise patients to immediately contact their healthcare provider for signs and symptoms of arterial or venous thromboembolism [see Warnings and Precautions (5.4 , 5.5) ] . Hypertension : Avastin can increase blood pressure. Advise patie...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Metastatic Colorectal Cancer Study AVF2107g The safety and efficacy of Avastin was evaluated in a double-blind, active-controlled study [AVF2107g (NCT00109070)] in 923 patients with previously untreated mCRC who were randomized (1:1:1) to placebo with bolus-IFL (irinotecan 125 mg/m 2 , fluorouracil 500 mg/m 2 , and leucovorin 20 mg/m 2 given once weekly for 4 weeks every 6 weeks), Avastin (5 mg/kg every 2 weeks) with bolus-IFL, or Avastin (5 mg/kg every 2 weeks) with fluorouracil and leucovorin. Enrollment to the Avastin with fluorouracil and leucovorin arm was discontinued after enrollment of 110 patients in accordance with the protocol-specified adaptive design. Avastin was continued until disease progression or unacceptable toxicity or for a maximum of 96 weeks. The main outcome measure was overall survival (OS). The median age was 60 years; 60% were male, 79% were White, 57% had an ECOG performance status of 0, 21% had a rectal primary and 28% received prior adjuvant chemotherapy. The dominant site of disease was extra-abdominal in 56% of patients and was the liver in 38% of patients. The addition of Avastin improved survival across subgroups defined by age (< 65 years, \u2265 ...",
  "brand_name": "Avastin",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA125085",
  "pharm_class_epc": [
   "Vascular Endothelial Growth Factor Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20250106",
  "set_id": "939b5d1f-9fb2-4499-80ef-0607aa6b114e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 91819,
  "serious": 82190,
  "death": 19294,
  "hospitalization": 26911,
  "primary_suspect": 91774,
  "top_reactions": [
   [
    "Off Label Use",
    14169
   ],
   [
    "Death",
    9203
   ],
   [
    "Diarrhoea",
    5679
   ],
   [
    "Fatigue",
    5461
   ],
   [
    "Disease Progression",
    5152
   ],
   [
    "Nausea",
    5148
   ],
   [
    "Hypertension",
    4733
   ],
   [
    "Vomiting",
    3671
   ],
   [
    "Anaemia",
    3670
   ],
   [
    "Neutropenia",
    3268
   ],
   [
    "Drug Ineffective",
    3007
   ],
   [
    "Pyrexia",
    2989
   ],
   [
    "Decreased Appetite",
    2964
   ],
   [
    "Asthenia",
    2890
   ],
   [
    "Thrombocytopenia",
    2756
   ]
  ],
  "by_year": {
   "2019": 6535,
   "2020": 6611,
   "2021": 7985,
   "2022": 8084,
   "2023": 8846,
   "2024": 8481,
   "2025": 8807,
   "2026": 4335
  },
  "by_year_primary": {
   "2019": 6535,
   "2020": 6603,
   "2021": 7982,
   "2022": 8079,
   "2023": 8840,
   "2024": 8474,
   "2025": 8799,
   "2026": 4327
  }
 },
 "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": "20040226",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/26/2004"
 },
 "trials": {
  "total": 3404,
  "completed": 1544,
  "terminated": 482,
  "with_results": 887,
  "industry": 1475,
  "phase3": 513,
  "results_share": 0.5744818652849741,
  "terminated_share": 0.14159811985898943
 },
 "pubmed": {
  "rct": 1109,
  "meta": 345,
  "recent_rct": 258,
  "cochrane": [
   {
    "pmid": "39136258",
    "title": "Immune checkpoint inhibitors plus platinum-based chemotherapy compared to platinum-based chemotherapy with or without bevacizumab for first-line treatment of older people with advanced non-small cell lung cancer",
    "year": "2024"
   },
   {
    "pmid": "33930176",
    "title": "Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer",
    "year": "2021"
   },
   {
    "pmid": "33316104",
    "title": "Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer",
    "year": "2020"
   },
   {
    "pmid": "25220133",
    "title": "Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 37424.04,
  "records": 655,
  "by_name": [
   [
    "Avastin",
    37424.04
   ]
  ],
  "names_checked": [
   "bevacizumab",
   "Avastin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1712,
  "beneficiaries": 335,
  "spend": 9033009.17,
  "by_brand": [
   {
    "brand": "Avastin",
    "claims": 1712,
    "per_claim": 5276.290403,
    "is_generic": false
   }
  ],
  "per_claim": 5276.290403037383
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "bevacizumab",
  "matched": "bevacizumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "Death appears in 2.3x the share of reports seen across all of FAERS (-10)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 100,
   "letter": "A",
   "why": [
    "1109 randomized trials and 345 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $37,424 tied to this drug last year: negligible",
    "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": 91,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, diarrhoea, fatigue. 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, brolucizumab, faricimab? 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.)"
 ]
}