Keytruda Dosage
Medically reviewed by A Ras MD.
Recommended Adult Dosing
Dosage forms: INJ
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
Gastric 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
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
Hepatic dosing
- 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
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
Hepatic dosing
- mild impairment: no adjustment; mod-severe impairment: not defined
SRC: NLM .