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Keytruda
pembrolizumab
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
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
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- multiple myeloma
- avoid: breastfeeding during tx and x4mo after D/C
- caution: patients of childbearing potential
- caution: patients 75 yo and older
- caution: thoracic XRT history
- caution: transplant history
- caution: transplant candidates
- caution: ipilimumab-associated immune toxicity, severe
Drug Interactions .
Overview
pembrolizumab
PD-1 blocking antibody
- immunomodulatory effects
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- rabies vaccine
Monitor/Modify Tx
- anthrax vaccine
- axitinib
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Adverse Reactions .
Serious Reactions
- immune-mediated reaction
- pneumonitis
- pneumonia
- pulmonary embolism
- pleural effusion
- septic shock
- febrile neutropenia
- infection, serious
- colitis
- hepatitis
- ascites
- sclerosing cholangitis
- endocrinopathy
- diabetes mellitus, type 1
- exocrine pancreatic insufficiency
- pancreatitis
- adrenal insufficiency
- hypophysitis
- hypopituitarism
- thyroiditis
- hyperthyroidism
- hypothyroidism
- nephritis
- acute kidney injury
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- myocarditis
- pericarditis
- vasculitis
- meningitis
- encephalitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- neuropathy
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- myositis
- rhabdomyolysis
- hypoparathyroidism
- hemolytic anemia
- aplastic anemia
- hemophagocytic lymphohistiocytosis
- immune thrombocytopenic purpura
- hemorrhage
- infusion reaction, severe
- hypersensitivity reaction
- anaphylaxis
- respiratory failure
- cardiac arrest
Common Reactions
- fatigue
- diarrhea
- rash
- nausea
- cough
- pruritus
- appetite decr.
- musculoskeletal pain
- dyspnea
- constipation
- hypothyroidism
- arthralgia
- fever
- vomiting
- headache
- abdominal pain
- weight loss
- asthenia
- UTI
- back pain
- hyperthyroidism
- pneumonia
- URI
- hematuria
- hyperglycemia
- anemia
- lymphopenia
- hyponatremia
- ALT or AST incr.
- hypoalbuminemia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LFTs at baseline, then periodically or more frequently if axitinib combo tx; Cr, TFTs at baseline, then periodically; glucose; signs/symptoms of infusion reaction
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of embryo-fetal toxicity, including spontaneous abortion and stillbirth, based on animal data with other PD-1/PD-L1 pathway inhibitors and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 4mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for pembrolizumab: other; CYP450: unknown
Excretion: for pembrolizumab: other; Half-life: 22 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
for pembrolizumab: binds to PD-1 receptor on T-cells, blocking PD-1 pathway-mediated inhibition of anti-tumor immune response, resulting in decreased tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
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