Pembrolizumab Dosage

Dosage forms:  INJ

Special Note

Melanoma

[metastatic or unresectable dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle

[Stage IIB, IIC, III dz, adjuvant tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 12mo

Non-small cell lung CA

[first-line tx, monotherapy, Stage III unresectable dz or metastatic dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor w/ no EGFR or ALK genomic tumor aberrations; give up to 24mo

[first-line tx, combo tx, squamous metastatic dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

[first-line tx, combo tx, nonsquamous metastatic dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; give up to 24mo

[progressive metastatic dz, monotherapy]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor; give up to 24mo

Squamous cell head/neck CA

[first-line tx, monotherapy, unresectable recurrent dz or metastatic dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor; give up to 24mo

[first-line tx, combo tx, unresectable recurrent dz or metastatic dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

[progressive recurrent or metastatic dz, monotherapy]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

Hodgkin lymphoma, relapsed or refractory

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

Primary mediastinal large B-cell lymphoma, relapsed or refractory

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts not requiring urgent cytoreductive tx; give up to 24mo

Urothelial carcinoma

[locally advanced or metastatic]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for platinum-ineligible pts or pts w/ progressive dz on or after platinum-containing chemo; give up to 24mo

[non-muscle invasive bladder CA in situ, BCG-refractory]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for high-risk cystectomy-ineligible pts w/ or w/o papillary tumors; give up to 24mo

Microsatellite instability-high or mismatch repair deficient solid tumors, unresectable or metastatic

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for progressive dz; give up to 24mo

Microsatellite instability-high or mismatch repair deficient colorectal CA, unresectable or metastatic

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

Gastric CA, locally advanced or metastatic

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ HER2-positive unresectable gastric or gastroesophageal junction adenocarcinoma; first-line tx; part of multi-drug chemo regimen; give up to 24mo

Esophageal CA, locally advanced or metastatic

[first-line tx, combo tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ esophageal or gastroesophageal junction CA not eligible for surgical resection or definitive XRT; give up to 24mo

[squamous cell, recurrent dz, monotherapy]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1 Combined Positive Score 10 or greater not eligible for surgical resection or definitive XRT; give up to 24mo

Cervical CA

[persistent or recurrent or metastatic]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor; part of multi-drug chemo regimen w/ or w/o bevacizumab; give up to 24mo

[recurrent or metastatic]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor; use as monotherapy for dz that has progressed on or after chemo; give up to 24mo

Hepatocellular CA

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for sorafenib refractory or intolerant dz; give up to 24mo

Merkel cell carcinoma, recurrent locally advanced or metastatic

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: give up to 24mo

Renal cell CA

[first-line tx, advanced dz]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: use w/ axitinib or lenvatinib; give up to 24 mo

[adjuvant tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ intermediate-high or high recurrence risk post-nephrectomy or pts post-nephrectomy and resection of metastatic lesions; give up to 12mo

Endometrial carcinoma, advanced

[mismatch repair proficient or non-microsatellite instability-high dz, combo tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ progressive dz not eligible for curative surgery or XRT; use w/ lenvatinib; give up to 24 mo

[microsatellite instability-high or mismatch repair deficient dz, monotherapy]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ progressive dz not eligible for curative surgery or XRT; give up to 24 mo

Tumor mutational burden-high solid tumors, unresectable or metastatic

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ progressive dz; give up to 24mo

Cutaneous squamous cell carcinoma

[200 mg IV x1 on day 1 of 21-day cycle]

Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ recurrent, metastatic, or locally advanced dz not curable by surgery or XRT; give up to 24mo

ER/PR-negative HER2-negative breast CA

[high-risk early-stage dz, neoadjuvant tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle x8 cycles; Alt: 400 mg IV x1 on day 1 of 42-day cycle x4 cycles; Info: give in neoadjuvant setting as part of multi-drug chemo regimen, then cont. in adjuvant setting as monotherapy

[high-risk early-stage dz, adjuvant tx]

Dose: 200 mg IV x1 on day 1 of 21-day cycle for up to 9 cycles; Alt: 400 mg IV x1 on day 1 of 42-day cycle for up to 5 cycles; Info: give as monotherapy

[unresectable locally recurrent or metastatic]

Dose: 200 mg IV x1 on day 1 of 21-day cycle; Alt: 400 mg IV x1 on day 1 of 42-day cycle; Info: for pts w/ PD-L1-expressing tumor; part of multi-drug chemo regimen; give up to 24mo

Small cell lung CA, refractory metastatic

[indication withdrawn in US]

Info: drug not shown to improve survival in pts w/ small cell lung CA

Hastric CA, PD-L1-positive recurrent locally advanced or metastatic

[indication withdrawn in US]

Info: drug not shown to improve survival in pts w/ PD-L1-positive recurrent locally advanced or metastatic gastric CA

Renal dosing

[see below]

eGFR >15: no adjustment; eGFR <15: not defined

HD/PD: not defined

Hepatic dosing

[see below]

mild impairment: no adjustment; mod-severe impairment: not defined

Recommended Peds Dosing

Dosage forms:  INJ

Melanoma

[12 yo and older]

Dose: 2 mg/kg/dose IV x1 on day 1 of 21-day cycle; Max: 200 mg/dose; Info: for pts w/ Stage IIB, IIC, or III dz as adjuvant tx; give up to 12mo

Hodgkin lymphoma, relapsed or refractory

[2 mg/kg/dose IV x1 on day 1 of 21-day cycle]

Max: 200 mg/dose; Info: give up to 24mo

Primary mediastinal large B-cell lymphoma, relapsed or refractory

[2 mg/kg/dose IV x1 on day 1 of 21-day cycle]

Max: 200 mg/dose; Info: for pts not requiring urgent cytoreductive tx; give up to 24mo

Microsatellite instability-high or mismatch repair deficient solid tumors, unresectable or metastatic

[2 mg/kg/dose IV x1 on day 1 of 21-day cycle]

Max: 200 mg/dose; Info: for progressive dz; give up to 24mo

Merkel cell carcinoma, recurrent locally advanced or metastatic

[2 mg/kg/dose IV x1 on day 1 of 21-day cycle]

Max: 200 mg/dose; Info: give up to 24mo

Tumor mutational burden-high solid tumors, unresectable or metastatic

[2 mg/kg/dose IV x1 on day 1 of 21-day cycle]

Max: 200 mg/dose; Info: for pts w/ progressive dz; not for pts w/ CNS cancers; give up to 24mo

Renal dosing

[see below]

eGFR >15: no adjustment; eGFR <15: not defined

HD/PD: not defined

Hepatic dosing

[see below]

mild impairment: no adjustment; mod-severe impairment: not defined