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Pembrolizumab Dosage

Applies to the following strength(s): 25 mg/mL ; 50 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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.

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