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Pembrolizumab Dosage

Medically reviewed by Drugs.com. Last updated on Nov 30, 2020.

Applies to the following strengths: 25 mg/mL; 50 mg

Usual Adult Dose for Melanoma - Metastatic

Monotherapy for unresectable or metastatic melanoma:
200 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity
OR
400 mg IV over 30 minutes every 6 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
OR
400 mg IV over 30 minutes every 6 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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Uses:
-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
-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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-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.

Use: For the treatment of metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL)

Usual Adult Dose for Urothelial Carcinoma

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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.

Usual Adult Dose for Bladder Cancer

200 mg IV over 30 minutes every 3 weeks until persistent or recurrent high-risk
NMIBC, disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until persistent or recurrent high-risk
NMIBC, disease progression, unacceptable toxicity, or up to 24 months

Use: 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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Uses:
-For first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
-For treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) 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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Uses:
-For first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
-For treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) 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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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 until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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 until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

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 until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
NOTE: Administer this drug in combination with lenvatinib 20 mg orally once a day.

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 Adult Dose for Squamous Cell Carcinoma

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation

Usual Adult Dose for Breast Cancer

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months
OR
400 mg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
NOTE: Administer this drug in combination with axitinib 5 mg orally 2 times a day.

Use: In combination with chemotherapy for treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10 or greater) as determined by an FDA-approved test

Usual Pediatric Dose for Hodgkin's Disease

6 months or 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

Use: For the treatment of pediatric patients 6 months or older with refractory cHL, or cHL that has relapsed after 2 or lines of therapy

Usual Pediatric Dose for Colorectal Cancer

6 months or 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

Uses:
-For the first-line treatment of pediatric patients 6 months or older with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
-For treatment of pediatric patients 6 months or older with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb) or greater] solid tumors, as determined by an FDA-approved test that have progressed following prior treatment and who have no satisfactory alternative treatment options (safety and effectiveness in pediatric patients with TMB-H central nervous system cancers have not been established).

Usual Pediatric Dose for Lymphoma

6 months or 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

Uses:
-For the treatment of pediatric patients 6 months or older with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy (this drug is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy).

Usual Pediatric Dose for Merkel Cell Carcinoma

6 months or 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

Use: For the treatment of pediatric patients 6 months or older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction (total bilirubin [TB] less than or equal to upper limit of normal [ULN] and AST greater than ULN or TB greater than 1 to 1.5 x ULN and any AST): No adjustment recommended.
Moderate to severe liver dysfunction (TB greater than 1.5 x ULN and any AST): Data not available

Dose Adjustments

No dose reductions of this drug recommended. Withhold or discontinue this drug to manage adverse reactions. In general, withhold this drug for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue this drug for Life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids. Dose modifications for adverse reactions that require management different from these general guidelines are summarized below.

RECOMMENDED DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
PNEUMONITIS:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
-Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy.
COLITIS:
-Grade 2 or 3: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
HEPATITIS WITH NO TUMOR INVOLVEMENT OF THE LIVER:
-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increases to more than 3 and up to 8 times upper limit of normal (UN) OR total bilirubin (TB) increases to more than 3 x ULN: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 to more than 1.5 and up to 3 x ULN: weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
HEPATITIS WITH TUMOR INVOLVEMENT OF THE LIVER (if AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue therapy based on recommendations for hepatitis with no liver involvement):
-Baseline AST or ALT is more than 1 and up to 3 x ULN and increases to more than 5 and up to 10 x ULN OR baseline AST or ALT is more than 3 and up 5 x ULN and increases to more than 8 and up to 10 times ULN: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
-AST or ALT increases to more than 10 x ULN OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.
and up to 8 x ULN OR total bilirubin increases to more than 3 and up to 8 x ULN OR total bilirubin increases to more than 1.5 and up to 3 x ULN: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
ENDOCRINOPATHIES:
-Grade 3 or 4: Withhold therapy until stable or permanently discontinue therapy depending on severity.
IMMUNE-MEDIATED NEPHRITIS:
-Grade 2: Withhold therapy; administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper) for Grade 2 or greater nephritis; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-Grade 3 or 4: Permanently discontinue therapy.
NEPHRITIS WITH RENAL DYSFUNCTION:
-Grade 2 or 3 increased blood creatinine: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 to more than 1.5 and up to 3 x ULN: weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
-Grade 4 increased blood creatinine: Permanently discontinue therapy.
EXFOLIATIVE DERMATOLOGIC CONDITIONS:
-Suspected Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS): Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 to more than 1.5 and up to 3 x ULN: weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
-Confirmed SJS or TEN: Permanently discontinue therapy.
MYOCARDITIS:
-Grade 2, 3, or 4: Permanently discontinue therapy.
NEUROLOGICAL TOXICITIES:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 to more than 1.5 and up to 3 x ULN: weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
-Grade 3 or 4: Permanently discontinue therapy.
HEMATOLOGIC TOXICITY IN PATIENTS WITH cHL OR PMBCL:
-Grade 4: Withhold until resolution to Grade 0 or 1.
INFUSION-RELATED REACTIONS:
-Grade 1 or 2 Interrupt or slow the rate of infusion.
-Grade 3 or 4: Permanently discontinue therapy.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS IN COMBINATION WITH AXITINIB:
Liver enzyme elevations (consider corticosteroid therapy):
-ALT or AST increases to at least 3 but less than 10 x ULN without concurrent total bilirubin at least 2 x ULN: Withhold both pembrolizumab axitinib until resolution to Grade 0 or 1; consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
-ALT or AST increases to more than 3 x ULN with concurrent total bilirubin at least 2 x ULN OR ALT or AST 10 x ULN or greater: Permanently discontinue both pembrolizumab and axitinib.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not coadminister other drugs through the same infusion line.
-Reconstitute and dilute before use.

Storage requirements:
-Store at room temperature for no more than 4 hours and under refrigeration for no more than 24 hours from time of reconstitution.
-Do not freeze.

General:
-As a therapeutic protein, this drug has immunogenicity potential.
-Atypical responses (i.e., an initial transient increase in tumor size or small new lesions within the first few months followed by tumor shrinkage) have been reported. Stable patients with initial evidence of disease progression should continue to be treated until disease progression is confirmed.
-Patients treated with this drug should be given the Patient Alert Card and be informed about the risks of therapy.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.