[{"_1":2,"_75":-5,"_76":-5},"loaderData",{"_3":4,"_12":13},"root",{"_5":-5,"_6":7,"_8":9,"_10":11},"user","recaptchaSiteKey","6Ler9Q4rAAAAAIntb4jBhAbPRXMJSQVneAzxg5M8","sentryTrace","78b40a0f7337ea1f6bcb58c08b17e927-90581d38cd675b71-0","sentryBaggage","sentry-environment=production,sentry-public_key=fbef35ac88c344bffa6f98009cf3736c,sentry-trace_id=78b40a0f7337ea1f6bcb58c08b17e927,sentry-org_id=4505908219871232,sentry-sampled=false,sentry-sample_rand=0.5770299972009332,sentry-sample_rate=0.5","routes/domain.$domainId",{"_14":15,"_71":72,"_5":-5,"_73":74},"domain",{"_16":17,"_14":18,"_19":20,"_21":22,"_23":24,"_25":26,"_27":28,"_29":-5,"_30":-5,"_31":-5,"_32":33,"_43":44,"_52":53,"_69":70},"id","cmhdjk4qh00bel202mfthf0pn","www.keytrudahcp.com","screenshotPath","sites/www.keytrudahcp.com/screenshot.jpg","htmlPath","sites/www.keytrudahcp.com/index.html","metaDescription","Healthcare professionals may find information on FDA-approved indications for KEYTRUDA® (pembrolizumab), along with related KEYNOTE trials. Explore the latest approvals here.","importantText","KEYTRUDA® (pembrolizumab) | Official Website for Health Care Professionals \n\n### This site is intended for health care professionals\n\n##### I am a health care professional\n\nProceed to site\n\n##### I am a patient or caregiver\n\n[Visit patient site](https://keytruda.com)\n\nThe information on this site is intended for health care professionals in the United States, its territories, and Puerto Rico, and is not intended for the general public.\n\n* Prescribing Information\n * [KEYTRUDA: View Prescribing Information](/prescribing-information/)\n* Medication Guide\n * [KEYTRUDA: View Medication Guide](https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf)\n* Indications\n * [View Selected Indications](/approved-indications)\n * [View Earlier-Stage Indications](/indication/earlier-stage-cancers/)\n\n* [Ask Merck](https://www.askmerckoncology.com)\n* Medical Information\n* Chat\n* [Visit Patient Site](https://www.keytruda.com/)\n\n[![KEYTRUDA® (pembrolizumab): Website for Health Care Professionals](/static/keytruda-logo.b6db1629.svg)](/ \"Home\")Menu\n\n* [Efficacy](/efficacy/)\n* Safety\n * [Selected Adverse Reactions](/safety/adverse-reactions/)\n * [Treatment Monitoring & Management](/safety/monitoring-managing-adverse-reactions/)\n* Biomarker Testing\n * [Biomarker Overview](/biomarker-testing/biomarker-overview/)\n * [PD⁠-⁠L1 Testing & Scoring](/biomarker-testing/pd-l1/)\n * [MSI/MMR Testing](/biomarker-testing/msi-mmr/)\n* Dosing & \n Preparation\n * [Dosing](/dosing/options/)\n * [Preparation, Storage & Administration](/dosing/preparation-storage-administration/)\n * [Dose Modifications](/dosing/dose-modifications/)\n* Resources\n * [Resource Center](/resources/hcp-and-patient-resources/)\n * [Patient Support Program](/resources/key-you-patient-support-program/)\n * [Mechanism of Action](/resources/mechanism-of-action/)\n\n##### Select 1 or more. Filters only apply to website pages with content about specific tumors.\n\nSORT BY\n\nDefault\n\nA to Z\n\nSelect Cancer Types\n\nNSCLC \nAdvanced Non⁠–⁠Small Cell Lung Cancer (NSCLC), Neoadjuvant Followed by Adjuvant Therapy for NSCLC, or Adjuvant Therapy for\n\nMelanoma \nAdvanced Melanoma or Adjuvant Therapy for\n\nRenal Cell Carcinoma (RCC) \nAdjuvant Treatment for RCC or Advanced\n\nHNSCC \nAdvanced Head and Neck Squamous Cell Carcinoma (HNSCC) or Neoadjuvant Followed by Adjuvant Therapy for Resectable Locally Advanced\n\nOther Cancer Types\n\nTriple-Negative Breast Cancer (TNBC) \nHigh-Risk Early-Stage or Locally Recurrent Unresectable or Metastatic\n\nNon-muscle Invasive Bladder Cancer (NMIBC) \nHigh-Risk\n\nCutaneous Squamous Cell Carcinoma (cSCC) \nAdvanced\n\nUrothelial Cancer \nLocally Advanced or Metastatic\n\nCervical Cancer \nAdvanced\n\nMSI⁠-⁠H/dMMR Colorectal Cancer (CRC) \nAdvanced\n\nHER2-Negative Gastric or GEJ Adenocarcinoma \nAdvanced\n\nEsophageal or GEJ Carcinoma \nAdvanced\n\nMerkel Cell Carcinoma (MCC) \nAdvanced\n\nBiliary Tract Cancer (BTC) \nAdvanced\n\nEndometrial Carcinoma \nAdvanced\n\nMulti-Cancer Types\n\nMSI⁠-⁠H/dMMR Cancers \nAdvanced\n\nClearApply Filters ( All )\n\n[Learn about another option](/qlex/)\n\nA Key to More Possibilities for Treating Your Patients:\n=======================================================\n\nKEYTRUDA is approved for 42 indications across 18 types of cancer.\n\nOne indication is for the treatment of patients with unresectable or metastatic melanoma.\n\n[View Select Indications](/approved-indications/)\n\n[View Earlier-Stage Indications](/indication/earlier-stage-cancers/)\n\n![](data:image/svg+xml;charset=utf-8,%3Csvg height='556' width='382' xmlns='http://www.w3.org/2000/svg' version='1.1'%3E%3C/svg%3E)\n\n![](data:image/png;base64,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)![](/static/97beab0ec05dabce687e912cb5620e49/6e660/hand-3-2x.png)\n\n![](/static/97beab0ec05dabce687e912cb5620e49/6e660/hand-3-2x.png)\n\nFDA APPROVED\n\n### Discover Another Option to Provide Treatment for Your Appropriate Patients\n\n[Learn More](/qlex/)\n\n[\n\n![](/static/images/badge-bookmark.png)\n\n#### Interactive Prescribing Information\n\nView Prescribing Information\n\n\n\n](/prescribing-information/)\n\n[\n\n![](/static/images/badge-iv.png)\n\nDosing & Preparation\n\n#### Dosing Options\n\nView Dosing Details\n\n\n\n](/dosing/options/)\n\n[\n\n![](/static/images/badge-safety.png)\n\nSafety\n\n#### Selected Adverse Reactions\n\nView More Information\n\n\n\n](/safety/adverse-reactions/)\n\n[\n\n![](/static/images/badge-info2.png)\n\nResources\n\n#### Download Guides and Support Information\n\nView HCP & Patient Resources\n\n\n\n](/resources/hcp-and-patient-resources/)\n\n[\n\n#### Another Combination Treatment With KEYTRUDA® (pembrolizumab)\n\nLearn about another important indication for a combination treatment for your appropriate patients.\n\nVisit Site\n\n\n\n](https://www.keytrudalenvimahcp.com/)\n\n[\n\nBiomarker Testing\n\n#### PD-L1 Testing & Scoring\n\nBiomarker status can be a road map for personalizing treatment.\n\nView Testing & Scoring\n\n\n\n](/biomarker-testing/pd-l1/)\n\nMechanism of Action\n-------------------\n\nSee how KEYTRUDA® (pembrolizumab) works.\n\n[View MOA](/resources/mechanism-of-action/)\n\nAsk Merck\n---------\n\nMerck is committed to helping you get your product questions answered. Connect with a Merck Associate now.\n\n[Get Connected](https://www.askmerckoncology.com)\n\nPatient Access & Reimbursement Support\n--------------------------------------\n\nThe Merck Access Program may help answer questions about billing and coding for KEYTRUDA, and co-pay assistance for eligible patients.\n\n[Learn About The Merck Access Program](https://www.merckaccessprogram-keytruda.com/)\n\nSelected Indications for KEYTRUDA® (pembrolizumab)\n--------------------------------------------------\n\n### Advanced Melanoma or Adjuvant Therapy for Melanoma\n\nKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.\n\nKEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.\n\n### Advanced Non⁠–⁠Small Cell Lung Cancer (NSCLC), Neoadjuvant Followed by Adjuvant Therapy for NSCLC, or Adjuvant Therapy for NSCLC\n\nKEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non⁠–⁠small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.\n\nKEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein‑bound, is indicated for the first‑line treatment of patients with metastatic squamous non⁠–⁠small cell lung cancer (NSCLC).\n\nKEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with non⁠–⁠small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD⁠-⁠L1) \\[tumor proportion score (TPS) ≥1%\\] as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and is:\n\n* stage III where patients are not candidates for surgical resection or definitive chemoradiation, or\n* metastatic.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic non⁠–⁠small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[tumor proportion score (TPS) ≥1%\\] as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.\n\nKEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) non–small cell lung cancer (NSCLC) in combination with platinum⁠-⁠containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.\n\nKEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC).\n\n### Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) or Neoadjuvant Followed by Adjuvant Therapy for Resectable Locally Advanced HNSCC\n\nKEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 \\[Combined Positive Score (CPS) ≥1\\] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.\n\nKEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).\n\nKEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.\n\n### Locally Advanced or Metastatic Urothelial Cancer\n\nKEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced (LA) or metastatic urothelial cancer (mUC).\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.\n\n### High-Risk Non-muscle Invasive Bladder Cancer (NMIBC)\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.\n\n### Advanced MSI⁠-⁠H/dMMR Cancers\n\nKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI⁠-⁠H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.\n\n### Advanced MSI⁠-⁠H/dMMR Colorectal Cancer (CRC)\n\nKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI⁠-⁠H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.\n\n### Advanced HER2-Negative Gastric or GEJ Adenocarcinoma\n\nKEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.\n\n### Advanced Esophageal or GEJ Carcinoma\n\nKEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:\n\n* in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express programmed death ligand 1 (PD-L1) \\[combined positive score (CPS) ≥1\\], or\n* as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.\n\n### Advanced Cervical Cancer\n\nKEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III⁠-⁠IVA).\n\nKEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\n### Advanced Biliary Tract Cancer (BTC)\n\nKEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).\n\n### Advanced Merkel Cell Carcinoma (MCC)\n\nKEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).\n\n### Adjuvant Treatment for RCC or Advanced Renal Cell Carcinoma (RCC)\n\nKEYTRUDA is indicated for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.\n\nKEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).\n\n### Advanced Endometrial Carcinoma\n\nKEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI⁠-⁠H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.\n\n### Advanced Cutaneous Squamous Cell Carcinoma (cSCC)\n\nKEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.\n\n### High-Risk Early-Stage or Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)\n\nKEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.\n\nKEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥10\\] as determined by an FDA-approved test.\n\nSelected Safety Information\n---------------------------\n\n### Severe and Fatal Immune-Mediated Adverse Reactions\n\n* KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD⁠-⁠1) or the programmed death ligand 1 (PD⁠-⁠L1), blocking the PD⁠-⁠1/PD⁠-⁠L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.\n\n* Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.\n\n* Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.\n\n#### _Immune-Mediated Pneumonitis_\n\n* KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.\n\n* Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.\n\n#### _Immune-Mediated Colitis_\n\n* KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.\n\n#### _Hepatotoxicity and Immune-Mediated Hepatitis_\n\n##### _KEYTRUDA_ AS A SINGLE AGENT\n\n* KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.\n\n##### _KEYTRUDA_ WITH AXITINIB\n\n* KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0–1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.\n\n#### _Immune-Mediated Endocrinopathies_\n\n##### ADRENAL INSUFFICIENCY\n\n* KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n##### HYPOPHYSITIS\n\n* KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n##### THYROID DISORDERS\n\n* KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.\n* Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE⁠-⁠091), including Grade 3 (0.3%) hypothyroidism.\n\n##### TYPE 1 DIABETES MELLITUS (DM), WHICH CAN PRESENT WITH DIABETIC KETOACIDOSIS\n\n* Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n#### _Immune-Mediated Nephritis With Renal Dysfunction_\n\n* KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.\n\n#### _Immune-Mediated Dermatologic Adverse Reactions_\n\n* KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.\n\n#### _Other Immune-Mediated Adverse Reactions_\n\n* The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. _Cardiac/Vascular_: Myocarditis, pericarditis, vasculitis; _Nervous System_: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; _Ocular_: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; _Gastrointestinal_: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; _Musculoskeletal and Connective Tissue_: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; _Endocrine_: Hypoparathyroidism; _Hematologic/Immune_: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.\n\n### Infusion-Related Reactions\n\n* KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.\n\n### Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)\n\n* Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD⁠-⁠1/PD⁠-⁠L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti–PD⁠-⁠1/PD⁠-⁠L1 treatments prior to or after an allogeneic HSCT.\n\n### Increased Mortality in Patients With Multiple Myeloma\n\n* In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti–PD⁠-⁠1/PD⁠-⁠L1 treatment in this combination is not recommended outside of controlled trials.\n\n### Embryofetal Toxicity\n\n* Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.\n\n### Adverse Reactions\n\n* In KEYNOTE⁠-⁠006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).\n\n* In KEYNOTE⁠-⁠054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE⁠-⁠716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE⁠-⁠054.\n\n* In KEYNOTE⁠-⁠189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).\n\n* In KEYNOTE⁠-⁠407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein‑bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE⁠-⁠407 were similar to those observed in KEYNOTE⁠-⁠189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE⁠-⁠407.\n\n* In KEYNOTE⁠-⁠042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).\n\n* In KEYNOTE⁠-⁠010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).\n\n* In KEYNOTE⁠-⁠671, adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single-agent adjuvant treatment, were generally similar to those occurring in patients in other clinical trials across tumor types receiving KEYTRUDA in combination with chemotherapy.\n\n* The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy or chemoradiotherapy were 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.\n\n* In the neoadjuvant phase of KEYNOTE⁠-⁠671, when KEYTRUDA was administered in combination with platinum-containing chemotherapy as neoadjuvant treatment, serious adverse reactions occurred in 34% of 396 patients. The most frequent (≥2%) serious adverse reactions were pneumonia (4.8%), venous thromboembolism (3.3%), and anemia (2%). Fatal adverse reactions occurred in 1.3% of patients, including death due to unknown cause (0.8%), sepsis (0.3%), and immune-mediated lung disease (0.3%). Permanent discontinuation of any study drug due to an adverse reaction occurred in 18% of patients who received KEYTRUDA in combination with platinum-containing chemotherapy; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of any study drug were acute kidney injury (1.8%), interstitial lung disease (1.8%), anemia (1.5%), neutropenia (1.5%), and pneumonia (1.3%).\n\n* Of the KEYTRUDA-treated patients who received neoadjuvant treatment, 6% of 396 patients did not receive surgery due to adverse reactions. The most frequent (≥1%) adverse reaction that led to cancellation of surgery in the KEYTRUDA arm was interstitial lung disease (1%).\n\n* In the adjuvant phase of KEYNOTE⁠-⁠671, when KEYTRUDA was administered as a single agent as adjuvant treatment, serious adverse reactions occurred in 14% of 290 patients. The most frequent serious adverse reaction was pneumonia (3.4%). One fatal adverse reaction of pulmonary hemorrhage occurred. Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 12% of patients who received KEYTRUDA as a single agent, given as adjuvant treatment; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of KEYTRUDA were diarrhea (1.7%), interstitial lung disease (1.4%), increased aspartate aminotransferase (1%), and musculoskeletal pain (1%).\n\n* Adverse reactions observed in KEYNOTE⁠-⁠091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.\n\n* In KEYNOTE⁠-⁠689, the most common adverse reactions (≥20%) in patients receiving KEYTRUDA were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%).\n\n* In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune-mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Fatal adverse reactions occurred in 1.1% of patients, including respiratory failure, clostridium infection, septic shock, and myocardial infarction (one patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 2.8% of patients who received KEYTRUDA as neoadjuvant treatment. The most frequent adverse reaction which resulted in permanent discontinuation of neoadjuvant KEYTRUDA in more than one patient was arthralgia (0.6%).\n\n* Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% did not receive surgery. Surgical cancellation on the KEYTRUDA arm was due to disease progression in 4%, patient decision in 3%, adverse reactions in 1.4%, physician’s decision in 1.1%, unresectable tumor in 0.6%, loss of follow-up in 0.3%, and use of non-study anti-cancer therapy in 0.3%.\n\n* Of the 323 KEYTRUDA-treated patients who received surgery following the neoadjuvant phase, 1.2% experienced delay of surgery (defined as on-study surgery occurring ≥9 weeks after initiation of neoadjuvant KEYTRUDA) due to adverse reactions, and 2.8% did not receive adjuvant treatment due to adverse reactions.\n\n* In the adjuvant phase of KEYNOTE-689, of the 255 patients who received at least one dose of KEYTRUDA, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA-treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). Fatal adverse reactions occurred in 5% of patients, including death not otherwise specified (1.2%), acute renal failure (0.4%), hypercalcemia (0.4%), pulmonary hemorrhage (0.4%), dysphagia/malnutrition (0.4%), mesenteric thrombosis (0.4%), sepsis (0.4%), pneumonia (0.4%), COVID-19 (0.4%), respiratory failure (0.4%), cardiovascular disorder (0.4%), and gastrointestinal hemorrhage (0.4%). Permanent discontinuation of adjuvant KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (≥1%) adverse reactions that led to permanent discontinuation of adjuvant KEYTRUDA were pneumonitis, colitis, immune-mediated hepatitis, and death not otherwise specified.\n\n* In KEYNOTE⁠-⁠048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).\n\n* In KEYNOTE⁠-⁠048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).\n\n* In KEYNOTE⁠-⁠012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.\n\n* In KEYNOTE⁠-⁠A39, when KEYTRUDA was administered in combination with enfortumab vedotin to patients with locally advanced or metastatic urothelial cancer (n=440), fatal adverse reactions occurred in 3.9% of patients, including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with enfortumab vedotin; the serious adverse reactions in ≥2% of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in 27% of patients. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (≥20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%), and urinary tract infection (21%).\n\n* In KEYNOTE⁠-⁠052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).\n\n* In KEYNOTE⁠-⁠045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).\n\n* In KEYNOTE⁠-⁠057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).\n\n* Adverse reactions occurring in patients with MSI⁠-⁠H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠158 and KEYNOTE⁠-⁠164, adverse reactions occurring in patients with MSI⁠-⁠H or dMMR cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.\n\n* In KEYNOTE⁠-⁠859, when KEYTRUDA was administered in combination with fluoropyrimidine- and platinum-containing chemotherapy, serious adverse reactions occurred in 45% of 785 patients. Serious adverse reactions in >2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%).\n\n* In KEYNOTE⁠-⁠590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).\n\n* Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy \\[EBRT\\] followed by brachytherapy \\[BT\\]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 294 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 34% of patients; those ≥1% included urinary tract infection (3.1%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 9% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (51%), urinary tract infection (35%), vomiting (34%), fatigue (28%), hypothyroidism (23%), constipation (20%), weight loss (19%), decreased appetite (18%), pyrexia (14%), abdominal pain and hyperthyroidism (13% each), dysuria and rash (12% each), back and pelvic pain (11% each), and COVID-19 (10%).\n\n* In KEYNOTE⁠-⁠826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD⁠-⁠L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).\n\n* KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).\n\n* For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).\n\n* For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).\n\n* In KEYNOTE⁠-⁠158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections \\[except urinary tract infections\\] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).\n\n* In KEYNOTE⁠-⁠966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%).\n\n* In KEYNOTE⁠-⁠017 and KEYNOTE⁠-⁠913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.\n\n* In KEYNOTE⁠-⁠426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).\n\n* In KEYNOTE⁠-⁠564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).\n\n* In KEYNOTE⁠-⁠868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).\n\n* Adverse reactions occurring in patients with MSI⁠-⁠H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.\n\n* Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).\n\n* In KEYNOTE⁠-⁠355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein⁠-⁠bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).\n\n### Lactation\n\n* Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.\n\n### Pediatric Use\n\n* In KEYNOTE⁠-⁠051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months).\n\n* Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%).\n\nGeriatric Use\n\n* Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older.\n\nALT = alanine aminotransferase; AST = aspartate aminotransferase; BT = brachytherapy; BTC = biliary tract cancer; CRC = colorectal cancer; CRT = chemoradiotherapy; cSCC = cutaneous squamous cell carcinoma; dMMR = mismatch repair deficient; EBRT = external beam radiation therapy; FIGO = International Federation of Gynecology and Obstetrics; FU = fluorouracil; GEJ = gastroesophageal junction; HER2 = human epidermal growth factor receptor 2; HNSCC = head and neck squamous cell carcinoma; ILD = interstitial lung disease; MCC = Merkel cell carcinoma; MSI⁠-⁠H = microsatellite instability-high; NMIBC = non-muscle invasive bladder cancer; NSCLC = non–small cell lung cancer; TNBC = triple-negative breast cancer.\n\n#### Before prescribing KEYTRUDA® (pembrolizumab), please read the accompanying [Prescribing Information](/prescribing-information/). The [Medication Guide](http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf) also is available.\n\n[![KEYTRUDA® (pembrolizumab): Website for Health Care Professionals](/static/keytruda-logo-light.5497cfc1.svg)](/ \"Home\")\n\n[Visit Patient Site](https://www.keytruda.com)\n\n[Contact Us](/contact-us/)\n\n* Efficacy Information\n --------------------\n \n* [Efficacy](/efficacy/)\n\n* Safety\n ------\n \n* [Selected Adverse Reactions](/safety/adverse-reactions/)\n* [Treatment Monitoring & Management](/safety/monitoring-managing-adverse-reactions/)\n\n* Biomarker Testing\n -----------------\n \n* [Biomarker Overview](/biomarker-testing/biomarker-overview/)\n* [PD-L1 Testing & Scoring](/biomarker-testing/pd-l1/)\n* [MSI/MMR Testing](/biomarker-testing/msi-mmr/)\n\n* Dosing & Preparation\n --------------------\n \n* [Dosing](/dosing/options/)\n* [Preparation, Storage & Administration](/dosing/preparation-storage-administration/)\n* [Dose Modifications](/dosing/dose-modifications/)\n\n* Resources\n ---------\n \n* [Resource Center](/resources/hcp-and-patient-resources/)\n* [Patient Support Program](/resources/key-you-patient-support-program/)\n* [Mechanism of Action](/resources/mechanism-of-action/)\n\n* * *\n\n[Privacy Policy](https://www.msdprivacy.com/us/en/)[Terms of Use](https://www.merck.com/terms-of-use/)[Site Map](/sitemap/)Cookie Preferences[Accessibility](https://www.msdaccessibility.com/)[Your Privacy Choices![Visit Your Privacy Choices](data:image/svg+xml;base64,PHN2ZyB3aWR0aD0iMzAiIGhlaWdodD0iMTQiIHZpZXdCb3g9IjAgMCAzMCAxNCIgZmlsbD0ibm9uZSIgeG1sbnM9Imh0dHA6Ly93d3cudzMub3JnLzIwMDAvc3ZnIj4KPGcgY2xpcC1wYXRoPSJ1cmwoI2NsaXAwXzE2NjBfMTY0MCkiPgo8cGF0aCBkPSJNMjIuMiAwSDdDMy4xIDAgMCAzLjEgMCA3QzAgMTAuOSAzLjEgMTQgNyAxNEgyMi4yQzI2LjEgMTQgMjkuMiAxMC45IDI5LjIgN0MyOS4yIDMuMSAyNiAwIDIyLjIgMFpNMTMuOCAxMi44SDdDMy44IDEyLjggMS4yIDEwLjIgMS4yIDdDMS4yIDMuOCAzLjggMS4yIDcgMS4ySDE2LjlMMTMuOCAxMi44Wk0yNC4zIDEwQzI0LjEgMTAuMiAyMy43IDEwLjIgMjMuNSAxMEwyMS4zIDcuOEwxOS4xIDEwQzE4LjkgMTAuMiAxOC41IDEwLjIgMTguMyAxMEMxOC4xIDkuOCAxOC4xIDkuNCAxOC4zIDkuMkwyMC40IDdMMTguMiA0LjhDMTggNC42IDE4IDQuMiAxOC4yIDRDMTguNCAzLjggMTguOCAzLjggMTkgNEwyMS4yIDYuMkwyMy40IDRDMjMuNiAzLjggMjQgMy44IDI0LjIgNEMyNC40IDQuMiAyNC40IDQuNiAyNC4yIDQuOEwyMi4xIDdMMjQuMyA5LjJDMjQuNSA5LjQgMjQuNSA5LjggMjQuMyAxMFoiIGZpbGw9IndoaXRlIi8+CjxwYXRoIGQ9Ik0xMi4zMDAxIDQuMTAwMDFDMTIuNTAwMSA0LjMwMDAxIDEyLjYwMDEgNC43MDAwMSAxMi40MDAxIDQuOTAwMDFMOC4yMDAxIDkuODAwMDFDOC4xMDAxIDkuOTAwMDEgOC4wMDAxIDEwIDcuOTAwMSAxMEM3LjcwMDEgMTAuMSA3LjQwMDEgMTAuMSA3LjIwMDEgOS45MDAwMUw1LjAwMDEgNy43MDAwMUM0LjgwMDEgNy41MDAwMSA0LjgwMDEgNy4xMDAwMSA1LjAwMDEgNi45MDAwMUM1LjIwMDEgNi43MDAwMSA1LjYwMDEgNi43MDAwMSA1LjgwMDEgNi45MDAwMUw3LjYwMDEgOC42MDAwMUwxMS40MDAxIDQuMTAwMDFDMTEuNjAwMSAzLjkwMDAxIDEyLjAwMDEgMy45MDAwMSAxMi4zMDAxIDQuMTAwMDFaIiBmaWxsPSJ3aGl0ZSIvPgo8L2c+CjxkZWZzPgo8Y2xpcFBhdGggaWQ9ImNsaXAwXzE2NjBfMTY0MCI+CjxyZWN0IHdpZHRoPSIzMCIgaGVpZ2h0PSIxNCIgZmlsbD0id2hpdGUiLz4KPC9jbGlwUGF0aD4KPC9kZWZzPgo8L3N2Zz4K)](https://dsr.msd.com/DSR/United_States/English/)[Consumer Health Data Privacy Policy](https://www.msdprivacy.com/us/en/chd-policy/)\n\n* * *\n\nCopyright © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. This site is intended only for residents of the United States and its territories, including Puerto Rico.\n\nUS-KEY-09727 09/25\n\n[\n\n![](data:image/svg+xml;charset=utf-8,%3Csvg height='32' width='84' xmlns='http://www.w3.org/2000/svg' version='1.1'%3E%3C/svg%3E)\n\n![Level Access Company Logo](/static/87605c1cd7efa536aa70754e6f35a45f/adcea/e-a-logo-e-a-hor-white-v-1-2x.png)\n\n![Level Access Company Logo](/static/87605c1cd7efa536aa70754e6f35a45f/adcea/e-a-logo-e-a-hor-white-v-1-2x.png)\n\n\n\n](https://www.essentialaccessibility.com/merck/)\n\n![](data:image/svg+xml;charset=utf-8,%3Csvg height='33.05548672566371' width='113.19' xmlns='http://www.w3.org/2000/svg' version='1.1'%3E%3C/svg%3E)\n\n![Merck Logo](/static/0764d6407a6f1e32a6a14972d76285c7/78db7/hcp-opt-merck-logo-reversed.svg)\n\n![Merck Logo](/static/0764d6407a6f1e32a6a14972d76285c7/78db7/hcp-opt-merck-logo-reversed.svg)\n\nSelected Indications\n\nKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. \nKEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.\n\nSelected Indications\n--------------------\n\nFor KEYTRUDA® (pembrolizumab)\n\nClose\n\n### Advanced Melanoma or Adjuvant Therapy for Melanoma\n\nKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.\n\nKEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.\n\n### Advanced Non⁠–⁠Small Cell Lung Cancer (NSCLC), Neoadjuvant Followed by Adjuvant Therapy for NSCLC, or Adjuvant Therapy for NSCLC\n\nKEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non⁠–⁠small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.\n\nKEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein‑bound, is indicated for the first‑line treatment of patients with metastatic squamous non⁠–⁠small cell lung cancer (NSCLC).\n\nKEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with non⁠–⁠small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD⁠-⁠L1) \\[tumor proportion score (TPS) ≥1%\\] as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and is:\n\n* stage III where patients are not candidates for surgical resection or definitive chemoradiation, or\n* metastatic.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic non⁠–⁠small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[tumor proportion score (TPS) ≥1%\\] as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.\n\nKEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) non–small cell lung cancer (NSCLC) in combination with platinum⁠-⁠containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.\n\nKEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC).\n\n### Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) or Neoadjuvant Followed by Adjuvant Therapy for Resectable Locally Advanced HNSCC\n\nKEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 \\[Combined Positive Score (CPS) ≥1\\] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.\n\nKEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).\n\nKEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.\n\n### Locally Advanced or Metastatic Urothelial Cancer\n\nKEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced (LA) or metastatic urothelial cancer (mUC).\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.\n\n### High-Risk Non-muscle Invasive Bladder Cancer (NMIBC)\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.\n\n### Advanced MSI⁠-⁠H/dMMR Cancers\n\nKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI⁠-⁠H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.\n\n### Advanced MSI⁠-⁠H/dMMR Colorectal Cancer (CRC)\n\nKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI⁠-⁠H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.\n\n### Advanced HER2-Negative Gastric or GEJ Adenocarcinoma\n\nKEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.\n\n### Advanced Esophageal or GEJ Carcinoma\n\nKEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:\n\n* in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express programmed death ligand 1 (PD-L1) \\[combined positive score (CPS) ≥1\\], or\n* as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.\n\n### Advanced Cervical Cancer\n\nKEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III⁠-⁠IVA).\n\nKEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥1\\] as determined by an FDA-approved test.\n\n### Advanced Biliary Tract Cancer (BTC)\n\nKEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).\n\n### Advanced Merkel Cell Carcinoma (MCC)\n\nKEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).\n\n### Adjuvant Treatment for RCC or Advanced Renal Cell Carcinoma (RCC)\n\nKEYTRUDA is indicated for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.\n\nKEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).\n\n### Advanced Endometrial Carcinoma\n\nKEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.\n\nKEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI⁠-⁠H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.\n\n### Advanced Cutaneous Squamous Cell Carcinoma (cSCC)\n\nKEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.\n\n### High-Risk Early-Stage or Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)\n\nKEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.\n\nKEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD⁠-⁠L1) \\[combined positive score (CPS) ≥10\\] as determined by an FDA-approved test.\n\nSelected Safety Information\n\n**Severe and Fatal Immune-Mediated Adverse Reactions:** KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD⁠-⁠1) or the programmed death ligand 1 (PD⁠-⁠L1), blocking the PD⁠-⁠1/PD⁠-⁠L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.\n\nSelected Safety Information\n---------------------------\n\nFor KEYTRUDA® (pembrolizumab)\n\nClose\n\n### Severe and Fatal Immune-Mediated Adverse Reactions\n\n* KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD⁠-⁠1) or the programmed death ligand 1 (PD⁠-⁠L1), blocking the PD⁠-⁠1/PD⁠-⁠L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.\n\n* Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.\n\n* Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.\n\n#### _Immune-Mediated Pneumonitis_\n\n* KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.\n\n* Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.\n\n#### _Immune-Mediated Colitis_\n\n* KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.\n\n#### _Hepatotoxicity and Immune-Mediated Hepatitis_\n\n##### _KEYTRUDA_ AS A SINGLE AGENT\n\n* KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.\n\n##### _KEYTRUDA_ WITH AXITINIB\n\n* KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0–1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.\n\n#### _Immune-Mediated Endocrinopathies_\n\n##### ADRENAL INSUFFICIENCY\n\n* KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n##### HYPOPHYSITIS\n\n* KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n##### THYROID DISORDERS\n\n* KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.\n* Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE⁠-⁠091), including Grade 3 (0.3%) hypothyroidism.\n\n##### TYPE 1 DIABETES MELLITUS (DM), WHICH CAN PRESENT WITH DIABETIC KETOACIDOSIS\n\n* Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.\n\n#### _Immune-Mediated Nephritis With Renal Dysfunction_\n\n* KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.\n\n#### _Immune-Mediated Dermatologic Adverse Reactions_\n\n* KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.\n\n#### _Other Immune-Mediated Adverse Reactions_\n\n* The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. _Cardiac/Vascular_: Myocarditis, pericarditis, vasculitis; _Nervous System_: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; _Ocular_: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; _Gastrointestinal_: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; _Musculoskeletal and Connective Tissue_: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; _Endocrine_: Hypoparathyroidism; _Hematologic/Immune_: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.\n\n### Infusion-Related Reactions\n\n* KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.\n\n### Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)\n\n* Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD⁠-⁠1/PD⁠-⁠L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD⁠-⁠1/PD⁠-⁠L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti–PD⁠-⁠1/PD⁠-⁠L1 treatments prior to or after an allogeneic HSCT.\n\n### Increased Mortality in Patients With Multiple Myeloma\n\n* In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti–PD⁠-⁠1/PD⁠-⁠L1 treatment in this combination is not recommended outside of controlled trials.\n\n### Embryofetal Toxicity\n\n* Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.\n\n### Adverse Reactions\n\n* In KEYNOTE⁠-⁠006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).\n\n* In KEYNOTE⁠-⁠054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE⁠-⁠716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE⁠-⁠054.\n\n* In KEYNOTE⁠-⁠189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).\n\n* In KEYNOTE⁠-⁠407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein‑bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE⁠-⁠407 were similar to those observed in KEYNOTE⁠-⁠189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE⁠-⁠407.\n\n* In KEYNOTE⁠-⁠042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).\n\n* In KEYNOTE⁠-⁠010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).\n\n* In KEYNOTE⁠-⁠671, adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single-agent adjuvant treatment, were generally similar to those occurring in patients in other clinical trials across tumor types receiving KEYTRUDA in combination with chemotherapy.\n\n* The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy or chemoradiotherapy were 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.\n\n* In the neoadjuvant phase of KEYNOTE⁠-⁠671, when KEYTRUDA was administered in combination with platinum-containing chemotherapy as neoadjuvant treatment, serious adverse reactions occurred in 34% of 396 patients. The most frequent (≥2%) serious adverse reactions were pneumonia (4.8%), venous thromboembolism (3.3%), and anemia (2%). Fatal adverse reactions occurred in 1.3% of patients, including death due to unknown cause (0.8%), sepsis (0.3%), and immune-mediated lung disease (0.3%). Permanent discontinuation of any study drug due to an adverse reaction occurred in 18% of patients who received KEYTRUDA in combination with platinum-containing chemotherapy; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of any study drug were acute kidney injury (1.8%), interstitial lung disease (1.8%), anemia (1.5%), neutropenia (1.5%), and pneumonia (1.3%).\n\n* Of the KEYTRUDA-treated patients who received neoadjuvant treatment, 6% of 396 patients did not receive surgery due to adverse reactions. The most frequent (≥1%) adverse reaction that led to cancellation of surgery in the KEYTRUDA arm was interstitial lung disease (1%).\n\n* In the adjuvant phase of KEYNOTE⁠-⁠671, when KEYTRUDA was administered as a single agent as adjuvant treatment, serious adverse reactions occurred in 14% of 290 patients. The most frequent serious adverse reaction was pneumonia (3.4%). One fatal adverse reaction of pulmonary hemorrhage occurred. Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 12% of patients who received KEYTRUDA as a single agent, given as adjuvant treatment; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of KEYTRUDA were diarrhea (1.7%), interstitial lung disease (1.4%), increased aspartate aminotransferase (1%), and musculoskeletal pain (1%).\n\n* Adverse reactions observed in KEYNOTE⁠-⁠091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.\n\n* In KEYNOTE⁠-⁠689, the most common adverse reactions (≥20%) in patients receiving KEYTRUDA were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%).\n\n* In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune-mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Fatal adverse reactions occurred in 1.1% of patients, including respiratory failure, clostridium infection, septic shock, and myocardial infarction (one patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 2.8% of patients who received KEYTRUDA as neoadjuvant treatment. The most frequent adverse reaction which resulted in permanent discontinuation of neoadjuvant KEYTRUDA in more than one patient was arthralgia (0.6%).\n\n* Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% did not receive surgery. Surgical cancellation on the KEYTRUDA arm was due to disease progression in 4%, patient decision in 3%, adverse reactions in 1.4%, physician’s decision in 1.1%, unresectable tumor in 0.6%, loss of follow-up in 0.3%, and use of non-study anti-cancer therapy in 0.3%.\n\n* Of the 323 KEYTRUDA-treated patients who received surgery following the neoadjuvant phase, 1.2% experienced delay of surgery (defined as on-study surgery occurring ≥9 weeks after initiation of neoadjuvant KEYTRUDA) due to adverse reactions, and 2.8% did not receive adjuvant treatment due to adverse reactions.\n\n* In the adjuvant phase of KEYNOTE-689, of the 255 patients who received at least one dose of KEYTRUDA, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA-treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). Fatal adverse reactions occurred in 5% of patients, including death not otherwise specified (1.2%), acute renal failure (0.4%), hypercalcemia (0.4%), pulmonary hemorrhage (0.4%), dysphagia/malnutrition (0.4%), mesenteric thrombosis (0.4%), sepsis (0.4%), pneumonia (0.4%), COVID-19 (0.4%), respiratory failure (0.4%), cardiovascular disorder (0.4%), and gastrointestinal hemorrhage (0.4%). Permanent discontinuation of adjuvant KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (≥1%) adverse reactions that led to permanent discontinuation of adjuvant KEYTRUDA were pneumonitis, colitis, immune-mediated hepatitis, and death not otherwise specified.\n\n* In KEYNOTE⁠-⁠048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).\n\n* In KEYNOTE⁠-⁠048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).\n\n* In KEYNOTE⁠-⁠012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.\n\n* In KEYNOTE⁠-⁠A39, when KEYTRUDA was administered in combination with enfortumab vedotin to patients with locally advanced or metastatic urothelial cancer (n=440), fatal adverse reactions occurred in 3.9% of patients, including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with enfortumab vedotin; the serious adverse reactions in ≥2% of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in 27% of patients. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (≥20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%), and urinary tract infection (21%).\n\n* In KEYNOTE⁠-⁠052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).\n\n* In KEYNOTE⁠-⁠045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).\n\n* In KEYNOTE⁠-⁠057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).\n\n* Adverse reactions occurring in patients with MSI⁠-⁠H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠158 and KEYNOTE⁠-⁠164, adverse reactions occurring in patients with MSI⁠-⁠H or dMMR cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.\n\n* In KEYNOTE⁠-⁠859, when KEYTRUDA was administered in combination with fluoropyrimidine- and platinum-containing chemotherapy, serious adverse reactions occurred in 45% of 785 patients. Serious adverse reactions in >2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%).\n\n* In KEYNOTE⁠-⁠590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).\n\n* Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy \\[EBRT\\] followed by brachytherapy \\[BT\\]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 294 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 34% of patients; those ≥1% included urinary tract infection (3.1%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 9% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (51%), urinary tract infection (35%), vomiting (34%), fatigue (28%), hypothyroidism (23%), constipation (20%), weight loss (19%), decreased appetite (18%), pyrexia (14%), abdominal pain and hyperthyroidism (13% each), dysuria and rash (12% each), back and pelvic pain (11% each), and COVID-19 (10%).\n\n* In KEYNOTE⁠-⁠826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD⁠-⁠L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).\n\n* KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).\n\n* For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).\n\n* For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).\n\n* In KEYNOTE⁠-⁠158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections \\[except urinary tract infections\\] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).\n\n* In KEYNOTE⁠-⁠966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%).\n\n* In KEYNOTE⁠-⁠017 and KEYNOTE⁠-⁠913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.\n\n* In KEYNOTE⁠-⁠426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).\n\n* In KEYNOTE⁠-⁠564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).\n\n* In KEYNOTE⁠-⁠868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).\n\n* Adverse reactions occurring in patients with MSI⁠-⁠H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.\n\n* Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.\n\n* In KEYNOTE⁠-⁠522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).\n\n* In KEYNOTE⁠-⁠355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein⁠-⁠bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).\n\n### Lactation\n\n* Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.\n\n### Pediatric Use\n\n* In KEYNOTE⁠-⁠051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months).\n\n* Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%).\n\nGeriatric Use\n\n* Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older.\n\nALT = alanine aminotransferase; AST = aspartate aminotransferase; BT = brachytherapy; BTC = biliary tract cancer; CRC = colorectal cancer; CRT = chemoradiotherapy; cSCC = cutaneous squamous cell carcinoma; dMMR = mismatch repair deficient; EBRT = external beam radiation therapy; FIGO = International Federation of Gynecology and Obstetrics; FU = fluorouracil; GEJ = gastroesophageal junction; HER2 = human epidermal growth factor receptor 2; HNSCC = head and neck squamous cell carcinoma; ILD = interstitial lung disease; MCC = Merkel cell carcinoma; MSI⁠-⁠H = microsatellite instability-high; NMIBC = non-muscle invasive bladder cancer; NSCLC = non–small cell lung cancer; TNBC = triple-negative breast cancer.\n\n#### Before prescribing KEYTRUDA® (pembrolizumab), please read the accompanying [Prescribing Information](/prescribing-information/). The [Medication Guide](http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf) also is available.\n\n \n\n![](https://thrtle.com/insync?vxii_pid=10015&vxii_pdid=)\n\n![](https://bh.contextweb.com/sr?action=add&token=YKLJCKQJN0Z1&us_privacy=&ch=1&url=https%3A%2F%2Fwww.keytrudahcp.com%2F&rr=&campaign=&frmtext=undefined&clktext=undefined¶m1=¶m2=¶m3=¶m4=¶m5=&cpurl=https%3A%2F%2Fwww.keytrudahcp.com%2F&cprr=&cpid=5965&cpext=clktext%3Aundefined%7Cch%3A1%7Curl%3Ahttps%3A%3A%2F%2Fwww.keytrudahcp.com%2F%7Ctoken%3AYKLJCKQJN0Z1%7Cfrmtext%3Aundefined)\n\n**Your privacy matters to us**\n\nThis website uses optional cookies and similar tracking technologies to improve your experience, help communicate relevant information, and see how the website works per our[US Privacy Notice](https://www.msdprivacy.com/us/en/supp-notice/) and[Global Online Tracking Policy](https://www.msdprivacy.com/us/en/cookie-privacy-policy/).\n\nIf you use our website, or click “Accept Optional Cookies,” you ask us to use and disclose your data for those reasons. 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