Keytruda

Adult Dosing .

Dosage forms:  INJ

Special Note

[equivalency or interchangeability info]

Info: not interchangeable with SC pembrolizumab/berahyaluronidase alfa; do not substitute on a mg to mg basis

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments

melanoma

[unresectable or metastatic disease]

Dose: 200 mg IV q3wk; Alt: 400 mg IV q6wk

[stage IIB, IIC, or III disease, adjuvant tx]

Dose: 200 mg IV q3wk for up to 12mo; Alt: 400 mg IV q6wk for up to 12mo

non-small cell lung CA

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with no EGFR or ALK genomic tumor aberrations

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo

[stage III unresectable or metastatic disease, first-line tx, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1-expressing tumor with no EGFR or ALK genomic tumor aberrations

[metastatic disease, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1-expressing tumor with disease progression on or after platinum-containing chemo

[resectable disease, neoadjuvant tx, combo tx]

Dose: 200 mg IV q3wk x12wk; Alt: 400 mg IV q6wk x12wk; Info: for patients with tumor >4cm or node-positive disease

[resectable disease, adjuvant tx following neoadjuvant tx, monotherapy]

Dose: 200 mg IV q3wk x39wk; Alt: 400 mg IV q6wk x39wk; Info: for patients with tumor >4cm or node-positive disease

[stage IB, II, or IIIA disease, adjuvant tx, monotherapy]

Dose: 200 mg IV q3wk for up to 12mo; Alt: 400 mg IV q6wk for up to 12mo; Info: following resection and platinum-based chemo

malignant pleural mesothelioma, unresectable advanced or metastatic

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: first-line tx; part of multi-drug chemo regimen

squamous cell head/neck CA

[PD-L1-expressing resectable locally advanced disease, neoadjuvant tx]

Dose: 200 mg IV q3wk x2 doses; Alt: 400 mg IV q6wk x1 dose

[PD-L1-expressing resectable locally advanced disease, adjuvant tx following neoadjuvant tx]

Dose: 200 mg IV q3wk for up to 1y; Alt: 400 mg IV q6wk for up to 1y; Info: start within 6wk after surgery in combo with XRT with or without cisplatin, then continue as monotherapy

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1-expressing tumor

[recurrent or metastatic disease, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with disease progression on or after platinum-containing chemo

Hodgkin lymphoma, classical

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with relapsed or refractory disease

primary mediastinal large B-cell lymphoma, relapsed or refractory

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients not requiring urgent cytoreductive tx

urothelial carcinoma

[locally advanced or metastatic disease, combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: use with enfortumab vedotin

[locally advanced or metastatic disease, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients ineligible for cisplatin-containing chemo or patients with disease progression on or after platinum-containing chemo

[muscle invasive bladder CA]

Dose: 200 mg IV q3wk x3 doses in neoadjuvant setting, then 200 mg IV q3wk x14 doses in adjuvant setting; Alt: 200 mg IV q3wk x3 doses in neoadjuvant setting, then 400 mg IV q6wk x7 doses in adjuvant setting; Info: for patients ineligible for cisplatin-containing chemo; use with enfortumab vedotin

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with high-risk disease not undergoing cystectomy with or without papillary tumors

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

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with progressive disease

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

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo

PD-L1-expressing gastric CA, locally advanced unresectable or metastatic

[HER2-positive disease]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with gastric or gastroesophageal junction adenocarcinoma; first-line tx; part of multi-drug chemo regimen

[HER2-negative disease]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with gastric or gastroesophageal junction adenocarcinoma; first-line tx; part of multi-drug chemo regimen

PD-L1-expressing esophageal CA, locally advanced or metastatic

[combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with esophageal or gastroesophageal junction CA not eligible for surgical resection or definitive chemoradiation

[squamous cell recurrent disease, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1 Combined Positive Score 10 or greater with esophageal or gastroesophageal junction CA not eligible for surgical resection or definitive chemoradiation

cervical CA

[FIGO 2014 stage III-IVA disease, combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo

[persistent, recurrent, or metastatic disease, combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1-expressing tumor

[recurrent or metastatic disease, monotherapy]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1-expressing tumor with disease progression on or after chemo

hepatocellular CA, hepatitis B-associated

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients who have received prior tx other than PD-1/PD-L1 inhibitor

biliary tract CA, locally advanced unresectable or metastatic

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: part of multi-drug chemo regimen

Merkel cell carcinoma, recurrent locally advanced or metastatic

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo

renal cell CA

[advanced disease, first-line tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: use with axitinib or lenvatinib

[adjuvant tx]

Dose: 200 mg IV q3wk for up to 12mo; Alt: 400 mg IV q6wk for up to 12mo; Info: for patients with intermediate-high or high recurrence risk post-nephrectomy or patients post-nephrectomy and resection of metastatic lesions

endometrial carcinoma

[advanced or recurrent disease, combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with advanced disease who have progressed after prior tx and not eligible for curative surgery or XRT; use with lenvatinib

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

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with advanced disease who have progressed after prior tx and not eligible for curative surgery or XRT

tumor mutational burden-high solid tumors, unresectable or metastatic

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with progressive disease

cutaneous squamous cell carcinoma

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with recurrent or metastatic disease, or locally advanced disease not curable by surgery or XRT

ER/PR-negative HER2-negative breast CA

[high-risk early-stage disease, neoadjuvant tx, combo tx]

Dose: 200 mg IV q3wk x24wk; Alt: 400 mg IV q6wk x24wk

[high-risk early-stage disease, adjuvant tx following neoadjuvant tx, monotherapy]

Dose: 200 mg IV q3wk for up to 27wk; Alt: 400 mg IV q6wk for up to 27wk (5 doses)

[locally recurrent unresectable or metastatic disease, combo tx]

Dose: 200 mg IV q3wk for up to 24mo; Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with PD-L1 Combined Positive Score 10 or greater

PD-L1-expressing ovarian CA

[200 mg IV q3wk for up to 24mo]

Alt: 400 mg IV q6wk for up to 24mo; Info: for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal CA who have received 1-2 lines of tx; use with paclitaxel +/- bevacizumab

small cell lung CA, relapsed (off-label)

[200 mg IV q3wk for up to 24mo]

Info: for patients who have received prior tx other than immune checkpoint inhibitors

renal dosing

[see below]

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

HD/PD: not defined

hepatic dosing

[see below]

bilirubin 1-3x ULN: no adjustment; bilirubin >3x ULN: not defined

Peds Dosing .

Dosage forms:  INJ

Special Note

[equivalency or interchangeability info]

Info: not interchangeable with SC pembrolizumab/berahyaluronidase alfa; do not substitute on a mg to mg basis

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments

melanoma

[12 yo and older]

Dose: 2 mg/kg/dose IV q3wk for up to 12mo; Max: 200 mg/dose; Info: for patients with stage IIB, IIC, or III disease as adjuvant tx

Hodgkin lymphoma, classical

[2 mg/kg/dose IV q3wk for up to 24mo]

Max: 200 mg/dose; Info: for patients with refractory disease or relapsed disease after at least 2 lines of tx

primary mediastinal large B-cell lymphoma, relapsed or refractory

[2 mg/kg/dose IV q3wk for up to 24mo]

Max: 200 mg/dose; Info: for patients not requiring urgent cytoreductive tx

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

[2 mg/kg/dose IV q3wk for up to 24mo]

Max: 200 mg/dose; Info: for patients with progressive disease

Merkel cell carcinoma, recurrent locally advanced or metastatic

[2 mg/kg/dose IV q3wk for up to 24mo]

Max: 200 mg/dose

tumor mutational burden-high solid tumors, unresectable or metastatic

[2 mg/kg/dose IV q3wk for up to 24mo]

Max: 200 mg/dose; Info: for patients with progressive disease; not for patients with CNS cancers

renal dosing

[see below]

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

HD/PD: not defined

hepatic dosing

[see below]

bilirubin 1-3x ULN: no adjustment; bilirubin >3x ULN: not defined