{
 "query": "nivolumab",
 "ingredient": "nivolumab",
 "slug": "nivolumab",
 "rxcui": "1597876",
 "brands": [
  "Opdivo"
 ],
 "names": [
  "nivolumab"
 ],
 "classes": [
  {
   "id": "L01FF",
   "name": "PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors"
  }
 ],
 "alternatives": [
  "atezolizumab",
  "avelumab",
  "cemiplimab",
  "dostarlimab",
  "durvalumab",
  "pembrolizumab",
  "retifanlimab",
  "tislelizumab",
  "toripalimab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 2,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma \u2022 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1) \u2022 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC) \u2022 adult patients with resectable (tumors \u22654 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3) \u2022 adult patients with resectable (tumors \u22654 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. (1.4) \u2022 adult patients with metastatic non-small cell lung cancer expressing PD\u2011L1 (\u22651%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. (1.5) \u2022 adult patients with metastatic o...",
  "contraindications": "None. \u2022 None. (4)",
  "warnings_and_cautions": "\u2022 Immune-Mediated Adverse Reactions: (5.1) \u2022 Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, and immune-mediated nephritis and renal dysfunction. \u2022 Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. \u2022 Withhold or permanently discontinue based on severity and type of reaction. (2.3) \u2022 Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue OPDIVO based on severity of reaction. (5.2) \u2022 Complications of allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. (5.3) \u2022 Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (5.4 , 8.1 , 8.3) \u2022 Treatment of patients with multiple myelo...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling. \u2022 Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] \u2022 Infusion-Related Reactions [see Warnings and Precautions (5.2) ] \u2022 Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence \u226520%) in patients were: \u2022 As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting, and urinary tract infection. (6.1) \u2022 In combination with ipilimumab: fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, constipation, decreased weight, and dizziness. (6.1) \u2022 In combination with platinum-doublet chemotherapy: nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy. (6.1) \u2022 In combination with ipilimumab and platinum-doublet...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage (1) 3/2026 Dosage and Administration (2) 3/2026 Warnings and Precautions (5) 5/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide) . Immune-Mediated Adverse Reactions Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and withholding or discontinuation of OPDIVO, including: \u2022 Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1) ] . \u2022 Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain [see Warnings and Precautions (5.1) ] . \u2022 Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding [see Warnings and Precautions (5.1) ] . \u2022 Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, and diabetes mellitus [see Warnings and Precautions (5.1) ] . \u2022 Nephritis and Renal Dysfunction: Advise patients to contact their healthcare provider immediately for ...",
  "spl_medguide": "MEDICATION GUIDE OPDIVO \u00ae (op-DEE-voh) (nivolumab) injection Read this Medication Guide before you start receiving OPDIVO and before each infusion. There may be new information. If your healthcare provider prescribes OPDIVO in combination with ipilimumab, also read the Medication Guide that comes with ipilimumab. If your healthcare provider prescribes OPDIVO in combination with cabozantinib, also read the Patient Information that comes with cabozantinib. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about OPDIVO? OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination ...",
  "clinical_studies": "14.1 Unresectable or Metastatic Melanoma Previously Treated Metastatic Melanoma CHECKMATE-037 (NCT01721746) was a multicenter, open-label trial that randomized (2:1) patients with unresectable or metastatic melanoma to receive OPDIVO 3 mg/kg intravenously every 2 weeks or investigator\u2019s choice of chemotherapy, either single-agent dacarbazine 1000 mg/m 2 every 3 weeks or the combination of carboplatin AUC 6 intravenously every 3 weeks and paclitaxel 175 mg/m 2 intravenously every 3 weeks. Patients were required to have progression of disease on or following ipilimumab treatment and, if BRAF V600 mutation positive, a BRAF inhibitor. The trial excluded patients with autoimmune disease, medical conditions requiring systemic immunosuppression, ocular melanoma, active brain metastasis, or a history of Grade 4 ipilimumab-related adverse reactions (except for endocrinopathies) or Grade 3 ipilimumab-related adverse reactions that had not resolved or were inadequately controlled within 12 weeks of the initiating event. Tumor assessments were conducted 9 weeks after randomization then every 6 weeks for the first year, and every 12 weeks thereafter. Efficacy was evaluated in a single-arm, non-...",
  "brand_name": "OPDIVO",
  "manufacturer": "E.R. Squibb & Sons, L.L.C.",
  "application_number": "BLA125554",
  "pharm_class_epc": [
   "Programmed Death Receptor-1 Blocking Antibody [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260812",
  "set_id": "f570b9c4-6846-4de2-abfa-4d0a4ae4e394",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 96669,
  "serious": 86487,
  "death": 24775,
  "hospitalization": 39544,
  "primary_suspect": 96609,
  "top_reactions": [
   [
    "Death",
    11901
   ],
   [
    "Malignant Neoplasm Progression",
    9881
   ],
   [
    "Off Label Use",
    6289
   ],
   [
    "Diarrhoea",
    5268
   ],
   [
    "Fatigue",
    4188
   ],
   [
    "Pyrexia",
    3748
   ],
   [
    "Intentional Product Use Issue",
    3329
   ],
   [
    "Nausea",
    3194
   ],
   [
    "Rash",
    3078
   ],
   [
    "Decreased Appetite",
    2913
   ],
   [
    "Dyspnoea",
    2704
   ],
   [
    "Pneumonia",
    2488
   ],
   [
    "Colitis",
    2286
   ],
   [
    "Pneumonitis",
    2203
   ],
   [
    "Hypothyroidism",
    2108
   ]
  ],
  "by_year": {
   "2019": 11415,
   "2020": 8975,
   "2021": 9451,
   "2022": 10067,
   "2023": 7718,
   "2024": 7626,
   "2025": 6913,
   "2026": 3625
  },
  "by_year_primary": {
   "2019": 11414,
   "2020": 8975,
   "2021": 9445,
   "2022": 10061,
   "2023": 7709,
   "2024": 7611,
   "2025": 6900,
   "2026": 3615
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 0,
  "anda": 0,
  "first_approval": "20141222",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "BRISTOL MYERS SQUIBB"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/22/2014"
 },
 "trials": {
  "total": 2037,
  "completed": 762,
  "terminated": 370,
  "with_results": 551,
  "industry": 1165,
  "phase3": 186,
  "results_share": 0.7230971128608924,
  "terminated_share": 0.18163966617574864
 },
 "pubmed": {
  "rct": 361,
  "meta": 74,
  "recent_rct": 254,
  "cochrane": [
   {
    "pmid": "30001476",
    "title": "Nivolumab for adults with Hodgkin's lymphoma (a rapid review using the software RobotReviewer)",
    "year": "2018"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2766718.78,
  "records": 17076,
  "by_name": [
   [
    "Opdivo",
    2766718.78
   ]
  ],
  "names_checked": [
   "nivolumab",
   "Opdivo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4120,
  "beneficiaries": 690,
  "spend": 50289570.25,
  "by_brand": [
   {
    "brand": "Opdivo",
    "claims": 4120,
    "per_claim": 12206.206371,
    "is_generic": false
   }
  ],
  "per_claim": 12206.206371359223
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "nivolumab",
  "matched": "nivolumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "Death appears in 2.8x the share of reports seen across all of FAERS (-12)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 82,
   "letter": "B",
   "why": [
    "361 randomized trials and 74 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 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": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,766,719 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)",
    "9 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, malignant neoplasm progression, diarrhoea. 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 atezolizumab, avelumab, cemiplimab? 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.)"
 ]
}