{
 "query": "pembrolizumab",
 "ingredient": "pembrolizumab",
 "slug": "pembrolizumab",
 "rxcui": "1547545",
 "brands": [
  "Keytruda"
 ],
 "names": [
  "pembrolizumab"
 ],
 "classes": [
  {
   "id": "L01FF",
   "name": "PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors"
  }
 ],
 "alternatives": [
  "atezolizumab",
  "avelumab",
  "cemiplimab",
  "dostarlimab",
  "durvalumab",
  "nivolumab",
  "retifanlimab",
  "tislelizumab",
  "toripalimab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) \u22651%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS \u22651%) as determined by an FDA-authorized test, with dis...",
  "contraindications": "None. ( 4 )",
  "warnings_and_cautions": "Immune-Mediated Adverse Reactions ( 5.1 ) 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, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue KEYTRUDA based on the severity of reaction. ( 5.2 ) 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 ) Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. ( ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling. Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] . Infusion-related reactions [see Warnings and Precautions (5.2) ]. Most common adverse reactions (reported in \u226520% of patients) were: KEYTRUDA as a single agent: fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism. ( 6.1 ) KEYTRUDA in combination with chemotherapy or chemoradiotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain. ( 6.1 ) KEYTRUDA in combination with chemotherapy and bevacizumab: peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 07/2026 Dosage and Administration ( 2 ) 07/2026 Warnings and Precautions ( 5 ) 05/2026",
  "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 be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of KEYTRUDA. These reactions may include: Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1) ] . Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain [see Warnings and Precautions (5.1) ] . Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding [see Warnings and Precautions (5.1) ] . Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or Type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . Nephritis: Advise patients to contact their healthcare provid...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: July 2026 MEDICATION GUIDE KEYTRUDA \u00ae (key-true-duh) (pembrolizumab) injection, for intravenous use What is the most important information I should know about KEYTRUDA? KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA 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. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side ...",
  "clinical_studies": "14.1 Melanoma Ipilimumab-Naive Melanoma The efficacy of KEYTRUDA was investigated in KEYNOTE-006 (NCT01866319), a randomized (1:1:1), open-label, multicenter, active-controlled trial in 834 patients. Patients were randomized to receive KEYTRUDA at a dose of 10 mg/kg intravenously every 2 weeks or 10 mg/kg intravenously every 3 weeks until disease progression or unacceptable toxicity or to ipilimumab 3 mg/kg intravenously every 3 weeks for 4 doses unless discontinued earlier for disease progression or unacceptable toxicity. Patients with disease progression could receive additional doses of treatment unless disease progression was symptomatic, was rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at 4 to 6 weeks with repeat imaging. Randomization was stratified by line of therapy (0 vs. 1), ECOG PS (0 vs. 1), and PD-L1 expression (\u22651% of tumor cells [positive] vs. <1% of tumor cells [negative]) according to an investigational use only (IUO) assay. Key eligibility criteria were unresectable or metastatic melanoma; no prior ipilimumab; and no more than one prior systemic treatment for metastatic melanoma. Patients with B...",
  "brand_name": "KEYTRUDA",
  "manufacturer": "Merck Sharp & Dohme LLC",
  "application_number": "BLA125514",
  "pharm_class_epc": [
   "Programmed Death Receptor-1 Blocking Antibody [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260710",
  "set_id": "9333c79b-d487-4538-a9f0-71b91a02b287",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 105077,
  "serious": 91978,
  "death": 18828,
  "hospitalization": 44314,
  "primary_suspect": 104927,
  "top_reactions": [
   [
    "Malignant Neoplasm Progression",
    12016
   ],
   [
    "Death",
    5861
   ],
   [
    "Diarrhoea",
    5745
   ],
   [
    "Fatigue",
    5133
   ],
   [
    "Off Label Use",
    4759
   ],
   [
    "Pyrexia",
    3892
   ],
   [
    "Rash",
    3727
   ],
   [
    "Nausea",
    3591
   ],
   [
    "Product Use In Unapproved Indication",
    3540
   ],
   [
    "Decreased Appetite",
    3318
   ],
   [
    "Hypertension",
    3233
   ],
   [
    "Hypothyroidism",
    2920
   ],
   [
    "Asthenia",
    2782
   ],
   [
    "Drug Ineffective",
    2575
   ],
   [
    "Product Use Issue",
    2566
   ]
  ],
  "by_year": {
   "2019": 6464,
   "2020": 6906,
   "2021": 8470,
   "2022": 12618,
   "2023": 15876,
   "2024": 16083,
   "2025": 17364,
   "2026": 7871
  },
  "by_year_primary": {
   "2019": 6464,
   "2020": 6906,
   "2021": 8458,
   "2022": 12591,
   "2023": 15857,
   "2024": 16061,
   "2025": 17318,
   "2026": 7848
  }
 },
 "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": "20140904",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "MERCK SHARP DOHME"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/04/2014"
 },
 "trials": {
  "total": 2993,
  "completed": 846,
  "terminated": 534,
  "with_results": 846,
  "industry": 1876,
  "phase3": 370,
  "results_share": 1.0,
  "terminated_share": 0.17841630471099232
 },
 "pubmed": {
  "rct": 383,
  "meta": 87,
  "recent_rct": 291,
  "cochrane": [
   {
    "pmid": "30036453",
    "title": "Pembrolizumab monotherapy versus chemotherapy for treatment of advanced urothelial carcinoma with disease progression during or following platinum-containing chemotherapy. A Cochrane Rapid Review",
    "year": "2018"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 4235999.21,
  "records": 46189,
  "by_name": [
   [
    "Keytruda",
    4235999.21
   ]
  ],
  "names_checked": [
   "pembrolizumab",
   "Keytruda"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11882,
  "beneficiaries": 1906,
  "spend": 140055039.83,
  "by_brand": [
   {
    "brand": "Keytruda",
    "claims": 11882,
    "per_claim": 11787.160396,
    "is_generic": false
   }
  ],
  "per_claim": 11787.160396397914
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "pembrolizumab",
  "matched": "pembrolizumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 89,
   "letter": "A",
   "why": [
    "Death appears in 2.0x the share of reports seen across all of FAERS (-6)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 84,
   "letter": "B",
   "why": [
    "383 randomized trials and 87 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 $4,235,999 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": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are malignant neoplasm progression, 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 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.)"
 ]
}