Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for: KEYTRUDA

Locally advanced or metastatic urothelial carcinoma: in patients who are ineligible for any platinum-containing chemotherapy; or in those who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. In combination with axitinib or lenvatinib for the first-line treatment of advanced renal cell carcinoma (RCC).

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression (or until persistent or recurrent high-risk NMIBC). RCC: give in combination with axitinib 5mg twice daily or lenvatinib 20mg once daily. May increase axitinib dose at intervals of 6 weeks or longer. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Not established.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Breast cancer:

Indications for: KEYTRUDA

High-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. In combination with chemotherapy, for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Adult Dosage:

Give as IV infusion over 30mins. Early-stage TNBC: 200mg every 3 weeks for 8 doses or 400mg every 6 weeks for 4 doses as neoadjuvant treatment for 24 weeks or until disease progression or unacceptable toxicity, then 200mg every 3 weeks for 9 doses or 400mg every 6 weeks for 5 doses as adjuvant treatment (single agent) for up to 27 weeks or until disease recurrence or unacceptable toxicity; see full labeling. Recurrent unresectable or metastatic TNBC: 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months. In combination with chemotherapy: give prior to chemotherapy when given on the same day (see full labeling). Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Not established.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Colorectal and other GI cancers:

Indications for: KEYTRUDA

Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR): colorectal cancer (CRC) as a first line treatment; CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; or solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatments. In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1–5cm above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation, either in combination with platinum- and fluoropyrimidine-based chemotherapy, or as a single agent after ≥1 prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib. Unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and no satisfactory alternative treatments.

Limitations of Use:

The safety and efficacy of Keytruda in pediatrics with MSI-H or TMB-H CNS cancers have not been established.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Esophageal or gastric cancer (in combination with chemotherapy): give prior to chemotherapy when given on the same day (see full labeling). Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Gastric cancer, esophageal cancer, HCC: not established. Give as IV infusion over 30mins. MSI-H or TMB-H cancer: 2mg/kg (max 200mg) every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Gynecologic Cancers:

Head and neck cancer:

Indications for: KEYTRUDA

In combination with platinum and fluorouracil for the first-line treatment of metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). As a single agent for the first-line treatment of metastatic or unresectable, recurrent HNSCC in patients whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. As a single agent for the treatment of recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In combination with chemotherapy: give prior to chemotherapy when given on the same day (see full labeling). Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Not established.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Leukemias, lymphomas, and other hematologic cancers:

Indications for: KEYTRUDA

Relapsed or refractory classical Hodgkin lymphoma (cHL) in adults. Refractory cHL in pediatric patients, or cHL that has relapsed after ≥2 prior lines of therapy. Refractory primary mediastinal large B-cell lymphoma (PMBCL) or in patients who have relapsed after ≥2 prior lines of therapy.

Limitations of Use:

Not recommended for the treatment of PMBCL in patients who require urgent cytoreductive therapy.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Give as IV infusion over 30mins. 2mg/kg (max 200mg) every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Melanoma and other skin cancers:

Indications for: KEYTRUDA

Unresectable or metastatic melanoma. Adjuvant treatment of melanoma with lymph node involvement following complete resection. Recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression or unacceptable toxicity (or up to 12 months without disease recurrence [adjuvant for melanoma] or 24 months [MCC, cSCC] in patients without disease progression). Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Melanoma, cSCC: not established. Give as IV infusion over 30mins. MCC: 2mg/kg (max 200mg) every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Pancreatic, thyroid, and other endocrine cancers:

Indications for: KEYTRUDA

Unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and no satisfactory alternative treatments.

Limitations of Use:

The safety and efficacy of Keytruda in pediatrics with TMB-H CNS cancers have not been established.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Give as IV infusion over 30mins. 2mg/kg (max 200mg) every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2

Respiratory and thoracic cancers:

Indications for: KEYTRUDA

As a single agent for the first-line treatment of Stage III non-small cell lung cancer (NSCLC) in patients who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. As a single agent for the treatment of metastatic NSCLC in patients whose tumors express PD-L1 (TPS ≥1%) 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 Keytruda. In combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. In combination with carboplatin and either paclitaxel or paclitaxel protein-bound for the first-line treatment of metastatic squamous NSCLC. Unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and no satisfactory alternative treatments.

Limitations of Use:

The safety and efficacy of Keytruda in pediatrics with TMB-H CNS cancers have not been established.

Adult Dosage:

Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In combination with chemotherapy: give prior to chemotherapy when given on the same day (see full labeling). Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

NSCLC: not established. Give as IV infusion over 30mins. TMB-H cancer: 2mg/kg (max 200mg) every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

KEYTRUDA Warnings/Precautions:

Monitor for pneumonitis; withhold dose if Grade 2 pneumonitis; permanently discontinue if Grade 3 or 4, or recurrent Grade 2 develops. Monitor for colitis; withhold dose if Grade 2 or 3 colitis; permanently discontinue if Grade 4 develops. Monitor for hepatitis with or without liver tumor involvement; withhold dose or permanently discontinue based on severity of elevated liver enzymes. Monitor for nephritis with renal dysfunction; withhold dose if Grade 2 or 3 increased blood creatinine; permanently discontinue if Grade 4 develops. Monitor for endocrinopathies (adrenal insufficiency, hypophysitis, thyroid disorders, hyperglycemia or other diabetes symptoms); withhold or permanently discontinue if Grade 3 or 4 develops based on severity. Withhold dose if Grade 4 hematological toxicity in cHL or PMBCL patients develops until resolution to Grade 0 or 1. Monitor for immune-mediated rash or dermatitis; withhold if suspected SJS, TEN, or DRESS; permanently discontinue if confirmed. Permanently discontinue if any severe or Grade 3 immune-mediated adverse reaction recurs, for any life-threatening immune-mediated adverse reaction (except endocrinopathies controlled with hormone replacement or hematological toxicity in cHL or PMBCL patients), persistent Grade 2 or 3 reactions that do not recover to Grade 0–1 within 12wks after last dose, or inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops. Permanently discontinue if Grade 2, 3, or 4 myocarditis develops. Withhold if Grade 2 neurological toxicities develop; permanently discontinue if Grade 3 or 4 neurological toxicities develop. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and manage promptly. Solid organ transplant recipients. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

KEYTRUDA Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

KEYTRUDA Interactions:

Increased mortality when pembrolizumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, hypothyroidism, palmar-plantar erythrodysesthesia, dysphonia. In combination with lenvatinib: also UTI, proteinuria, hemorrhagic events.

Generic Drug Availability:

NO

How Supplied:

Single-use vial (4mL)—1, 2