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Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
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). Adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Keytruda Dosage and Administration
Adult
Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks. Urothelial carcinoma, BCG-unresponsive NMIBC: continue until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression; (and/or until persistent or recurrent high-risk NMIBC). Adjuvant for RCC: continue until disease recurrence, unacceptable toxicity, or up to 12 months. Advanced 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
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
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.
Keytruda Dosage and Administration
Adult
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
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-approved test. 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.
Keytruda Dosage and Administration
Adult
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
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
In combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. As a single agent for recurrent or metastatic cervical cancer in patients with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. In combination with lenvatinib, for advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), in patients with disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. As a single agent for advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, in patients with disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Keytruda Dosage and Administration
Adult
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). Cervical cancer (in combination therapy): give prior to chemotherapy with or without bevacizumab when given on the same day. Endometrial carcinoma (in combination therapy): give with lenvatinib 20mg once daily. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.
Children
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
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.
Keytruda Dosage and Administration
Adult
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
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
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.
Keytruda Dosage and Administration
Adult
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
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 Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
Unresectable or metastatic melanoma. Adjuvant treatment of Stage IIB, IIC, or III melanoma 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.
Keytruda Dosage and Administration
Adult
Give as IV infusion over 30mins. 200mg every 3 weeks or 400mg every 6 weeks. MCC, cSCC: continue until disease progression, unacceptable toxicity, or up to 24 months (in patients without disease progression). Adjuvant for melanoma: continue until disease recurrence, unacceptable toxicity, or up to 12 months. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.
Children
Melanoma, adjuvant for melanoma (<12yrs), cSCC: not established. Give as IV infusion over 30mins. 2mg/kg (max 200mg) every 3 weeks. MCC: continue until disease progression, unacceptable toxicity, or up to 24 months (in patients without disease progression). Adjuvant for melanoma: continue until disease recurrence, unacceptable toxicity, or up to 12 months. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Manufacturer
Keytruda Indications
Keytruda Dosage and Administration
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Not Applicable
Keytruda Pharmacokinetics
See Literature
Keytruda Interactions
Keytruda Adverse Reactions
Not Applicable
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
In combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (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 patients with metastatic squamous NSCLC. As a single agent for the first-line treatment of Stage III NSCLC in patients who are not candidates for surgical resection or definitive chemoradiation, or metastatic, 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. As a single agent for adjuvant treatment following resection and platinum-based chemotherapy in adults with Stage IB (T2a ≥4cm), II, or IIIA NSCLC.
Keytruda Dosage and Administration
Adult
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 combination with chemotherapy: give prior to chemotherapy when given on the same day (see full labeling). Adjuvant for NSCLC: continue until disease recurrence, unacceptable toxicity, or up to 12 months. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.
Children
Not established.
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
Rx
General Description
Pembrolizumab 25mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Programmed death receptor-1 (PD-1) blocking antibody.
How Supplied
Single-use vial (4mL)—1, 2
Manufacturer
Generic Availability
NO
Keytruda Indications
Indications
Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior therapy and have no satisfactory alternative treatments. 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 have no satisfactory alternative treatments.
Limitations of Use
The safety and efficacy in pediatrics with MSI-H or TMB-H CNS cancers have not been established.
Keytruda Dosage and Administration
Adult
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
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 Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
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 Pharmacokinetics
Distribution
The geometric mean value (CV%) for volume of distribution at steady state is 6.0 L (20%).
Elimination
Half-life: 22 days.
Keytruda Interactions
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.
Keytruda Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain, hypothyroidism. In combination with chemotherapy: also asthenia, vomiting, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss. In combination with axitinib: also hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, mucosal inflammation, dysphonia. In combination with lenvatinib: also hypertension, musculoskeletal disorders, vomiting, stomatitis, weight loss, palmar-plantar erythrodysesthesia, dysphonia, UTI, proteinuria, hemorrhagic events, acute kidney injury.
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
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