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Pembrolizumab Dosage

Medically reviewed by Drugs.com. Last updated on Jan 28, 2019.

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 platinum chemotherapy for the first-line
treatment of patients with metastatic nonsquamous NSCLC with no EGFR or
ALK genomic tumor aberrations
-In combination with carboplatin and either paclitaxel or nab-paclitaxel for the
first-line treatment of patients with metastatic squamous 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

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 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 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 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 with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of 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)

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

Recommended Dose Modifications for Adverse Reactions:
IMMUNE-MEDIATED PNEUMONITIS:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy.
IMMUNE-MEDIATED COLITIS:
-Grade 2 or 3: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-Grade 4: Permanently discontinue therapy.
IMMUNE-MEDIATED HEPATITIS IN PATIENTS WITH HCC:
-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 5 times upper limit of normal (ULN) if baseline less than 2 times ULN: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-AST or ALT greater than 3 x baseline if baseline greater than or equal to 2 times
ULN: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-Total bilirubin greater than 2 mg/dL if baseline less than 1.5 mg/dL or total bilirubin greater than 3 mg/dL regardless of baseline levels: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-ALT or AST greater than 10 times ULN or Child-Pugh score greater than or equal to 9 points: Permanently discontinue therapy.
-GI bleeding suggestive of portal hypertension or new onset of clinically detectable ascites or encephalopathy: Permanently discontinue therapy.
IMMUNE-MEDIATED HEPATITIS IN PATIENTS WITHOUT HCC:
-AST or ALT greater than 3 but no more than 5 x ULN or total bilirubin greater than 1.5 but no more than 3 x ULN: Permanently discontinue therapy.
-In patients without liver metastases, AST or ALT greater than 5 x ULN or total
bilirubin greater than 3 x ULN: Permanently discontinue therapy.
-In patients with liver metastasis and Grade 2 AST or ALT at baseline with an
increase in AST or ALT of 50% or more relative to baseline that persists for at least 1 week: Permanently discontinue therapy.
IMMUNE-MEDIATED ENDOCRINOPATHIES:
-Grade 3 or 4: Withhold therapy until clinically stable.
IMMUNE-MEDIATED NEPHRITIS:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-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.
OTHER IMMUNE-MEDIATED ADVERSE REACTIONS:
-Grade 2 or 3 based on the severity and type of reaction: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
-Grade 3 based on the severity and type of reaction or Grade 4: Permanently discontinue therapy.
RECURRENT IMMUNE-MEDIATED ADVERSE REACTIONS:
-Recurrent Grade 2 pneumonitis: Permanently discontinue therapy.
-Recurrent Grade 3 or 4 immune-mediated adverse reaction: Permanently discontinue therapy.
INABILITY TO TAPER CORTICOSTEROID:
-Grade 2 or 3 adverse reactions lasting 12 weeks or longer after last dose of this drug: Permanently discontinue therapy.
PERSISTENT GRADE 2 OR 3 ADVERSE REACTION (EXCLUDING ENDOCRINOPATHY):
-Grade 1 or 2: Permanently discontinue therapy.
INFUSION-RELATED REACTIONS:
-Grade 1 or 2: Interrupt or slow the rate of infusion.
-Grade 3 or 4: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

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.
-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.

Further information

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

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