Usual Adult Dose for Melanoma -- Metastatic:
Unresectable or metastatic melanoma:
200 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity
Adjuvant treatment of melanoma:
200 mg IV over 30 minutes every 3 weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence
Uses:
-Treatment of patients with unresectable or metastatic melanoma
-Adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
Usual Adult Dose for Non-Small Cell Lung Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Uses:
SINGLE AGENT:
-For the first-line treatment of patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (Tumor Proportion Score [TPS] 1% or greater) as determined by an FDA-approved test with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic
-For the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1% or greater) as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving this drug
COMBINATION THERAPY:
-In combination with pemetrexed and platinum chemotherapy for first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
-In combination with carboplatin and either paclitaxel or paclitaxel protein-bound for first-line treatment of patients with metastatic squamous NSCLC
Usual Adult Dose for Small Cell Lung Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one prior line of therapy
Usual Adult Dose for Head and Neck Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Comments:
-When administering this drug in combination with chemotherapy, administer this drug prior to chemotherapy when given on the same day.
-Refer to the Prescribing Information for the chemotherapy agents administered in combination with this drug for recommended dosing information.
Uses:
-As a single agent for first line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell cancer (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] greater than or equal to 1) as determined by an FDA-approved test
-As a single agent for treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
-In combination with platinum and fluorouracil (FU) for first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC)
Usual Adult Dose for Hodgkin's Disease:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy
Usual Adult Dose for Urothelial Carcinoma:
Locally advanced or metastatic urothelial carcinoma:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
High-risk BCG-unresponsive non-muscle invasive bladder cancer:
200 mg IV over 30 minutes every 3 weeks until persistent or recurrent high-risk NMIBC, disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression
Uses:
-For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 10 or greater) as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
-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.
-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
Usual Adult Dose for Colorectal Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Uses: For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Usual Adult Dose for Solid Tumors:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Uses: For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Usual Adult Dose for Gastric Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 Positive Score (CPS) 1 or greater as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine-and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy
Usual Adult Dose for Cervical Cancer:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1 or greater) as determined by an FDA-approved test
Usual Adult Dose for Lymphoma:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of therapy (not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)
Usual Adult Dose for Hepatocellular Carcinoma:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Usual Adult Dose for Merkel Cell Carcinoma:
200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)
Usual Adult Dose for Renal Cell Carcinoma:
200 mg IV over 30 minutes every 3 weeks in combination with 5 mg axitinib orally 2 times a day until disease progression, unacceptable toxicity, or for pembrolizumab up to 24 months in patients without disease progression
Comments:
-When axitinib is used in combination with this drug, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of 6 weeks or longer.
-See the prescribing information for recommended axitinib dosing information.
Use: In combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC)
Usual Adult Dose for Esophageal Carcinoma:
200 mg IV over 30 minutes every 3 weeks in combination until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10 or greater) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy
Usual Adult Dose for Endometrial Carcinoma:
200 mg IV over 30 minutes every 3 weeks in combination with lenvatinib 20 mg orally once daily until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Comments:
-Refer to the lenvatinib prescribing information for recommended dosing.
Use: In combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation
Usual Pediatric Dose for Hodgkin's Disease:
2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of pediatric patients 2 years and older with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy
Usual Pediatric Dose for Colorectal Cancer:
2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Uses: For the treatment of pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Usual Pediatric Dose for Solid Tumors:
2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Uses: For the treatment of pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Usual Pediatric Dose for Lymphoma:
2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of pediatric patients 2 years and older with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of therapy (not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)
Usual Pediatric Dose for Merkel Cell Carcinoma:
2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Use: For the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)
 Detailed Keytruda dosage information
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Keytruda injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
