Skip to Content

Pembrolizumab Dosage

Medically reviewed on December 28, 2017.

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

Usual Adult Dose for Melanoma - Metastatic

200 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Use: Treatment of patients with unresectable or metastatic melanoma

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

Comments:
-When administering this drug in combination with chemotherapy, it should be administered prior to chemotherapy when given on the same day.

Uses:
-As a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] 50% or greater) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
-As a single agent 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 carboplatin, as first-line treatment of patients with metastatic nonsquamous NSCLC

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

Use: 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

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

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 locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy

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 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 or unacceptable toxicity, or up to 24 months in patients without disease progression

Use: For the treatment of pediatric patients 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 30 minutes every 3 weeks until disease progression or 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 30 minutes every 3 weeks until disease progression or 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

Renal Dose Adjustments

See DOSE ADJUSTMENTS.

Liver Dose Adjustments

See DOSE ADJUSTMENTS.

Dose Adjustments

WITHHOLD THERAPY FOR ANY OF THE FOLLOWING:
-Grade 2 pneumonitis
-Grade 2 or 3 colitis
-Grade 3 or 4 endocrinopathies
-Grade 4 hematological toxicity in Classical Hodgkin Lymphoma (cHL) patients
-Grade 2 nephritis
-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
-Any other severe or Grade 3 treatment-related adverse reaction
RESUME THERAPY IN PATIENTS WHOSE ADVERSE REACTIONS RECOVER TO GRADE 0 or 1.

PERMANENTLY DISCONTINUE THERAPY FOR ANY OF THE FOLLOWING:
-Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy, or hematological toxicity in patients with cHL)
-Grade 3 or 4 pneumonitis or recurrent Grade 2 pneumonitis
-Grade 3 or 4 nephritis
-AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN: For patients with liver metastasis who begin treatment with Grade 2 AST or ALT, if AST or ALT increases by greater than or equal to 50% relative to baseline and lasts for at least 1 week
-Grade 3 or 4 infusion-related reactions
-Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
-Persistent Grade 2 or 3 adverse reactions (excluding endocrinopathies controlled with hormone replacement therapy) that do not recover to Grade 0 or 1 within 12 weeks after the last dose of this drug
-Any severe or Grade 3 treatment-related adverse reaction that recurs

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

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.
-Patients treated with this drug should be given the Patient Alert Card and be informed about the risks of therapy.

Further information

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

Hide