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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:

Additional dosage information:

Usual Adult Dose for Melanoma - Metastatic

2 mg/kg IV infusion over 30 minutes

Duration of therapy: Administer every 3 weeks until disease progression or unacceptable toxicity

Uses: Treatment of patients with unresectable or metastatic melanoma

Usual Adult Dose for Non-Small Cell Lung Cancer

2 mg/kg IV infusion over 30 minutes

Duration of therapy: Administer every 3 weeks until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 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. (This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials).

Usual Adult Dose for Head and Neck Cancer

200 mg IV over 30 minutes

Duration of therapy: Administer every 3 weeks until disease progression or 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

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

WITHHOLD THIS DRUG FOR ANY OF THE FOLLOWING:
-Grade 2 pneumonitis
-Grade 2 or 3 colitis
-Grade 3 or 4 endocrinopathies
-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 THIS DRUG IN PATIENTS WHOSE ADVERSE REACTIONS RECOVER TO GRADE 0 or 1.
PERMANENTLY DISCONTINUE THIS DRUG FOR ANY OF THE FOLLOWING:
-Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
-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 to 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 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not co-administer 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.

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