Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Keytruda Indications
Indications
As a single agent to treat 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. In combination with enfortumab vedotin to treat locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy. As a single agent to treat 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
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Keytruda Indications
Indications
Keytruda Dosage and Administration
Adult
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
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
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
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 in any setting 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
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Keytruda Indications
Indications
Keytruda Dosage and Administration
Adult
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Keytruda Indications
Indications
Limitations of Use
Keytruda Dosage and Administration
Adult
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Keytruda Indications
Indications
Keytruda Dosage and Administration
Adult
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
General Description
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
Not Applicable
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
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
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
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
Keytruda Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
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 TMB-H CNS cancers have not been established.
Keytruda Dosage and Administration
Adult
Children
Keytruda Contraindications
Not Applicable
Keytruda Boxed Warnings
Not Applicable
Keytruda Warnings/Precautions
Warnings/Precautions
Keytruda Pharmacokinetics
Absorption
Steady-state concentrations reached by 16 weeks of repeated dosing with an every 3-week regimen, and the systemic accumulation was 2.1-fold.
Peak concentration, trough concentration, and area under the plasma concentration vs time curve at steady state increased dose proportionally in the dose range of 2–10mg/kg every 3 weeks.
Distribution
Geometric mean value (CV%) for volume of distribution (at steady state): 6.0 L (20%).
Elimination
Half-life: 22 days.
Clearance (CV%): ~23% lower (geometric mean, 195 mL/day [40%]) at steady state vs that after the first dose (252 mL/day [37%]).
Keytruda Interactions
Interactions
Keytruda Adverse Reactions
Adverse Reactions
Keytruda Clinical Trials
See Literature
Keytruda Note
Not Applicable
Keytruda Patient Counseling
See Literature
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