Dosage form and strength: 100 mg/4 mL (25 mg/mL) solution in single-dose vial.

Applies to the following strengths: 25 mg/mL; 50 mg200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks in combination with 5 mg axitinib orally 2 times a day until disease progression, unacceptable toxicity, or for pembrolizumab up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks in combination until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV over 30 minutes every 3 weeks in combination with lenvatinib 20 mg orally once daily until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progressionMild liver dysfunction (total bilirubin [TB] less than or equal to upper limit of normal [ULN] and AST greater than ULN or TB greater than 1 to 1.5 x ULN and any AST): No adjustment recommended.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Detailed Pembrolizumab dosage information for adults and children.

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200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionRefer to prescribing information for chemotherapy agents administered in combination with pembrolizumab for recommended dosing information, as appropriateFirst-line treatment for metastatic or with unresectable, recurrent HNSCC in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test or in patients with disease progression on or after platinum-containing chemotherapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progressionRefer to prescribing information for chemotherapy agents administered in combination with pembrolizumab for recommended dosing information, as appropriateIndicated for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progressionIndicated for refractory classical Hodgkin lymphoma (cHL) in adults and children or in patients who have relapsed after ≥3 prior lines of therapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progression200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma tumors expressing PD-L1 (CPS ≥1) with disease progression on or after ≥2 prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1)200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after ≥2 prior lines of therapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for treatment of patients with hepatocellular carcinoma (HCC) who have been previously-treated with sorafenib200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for treatment of recurrent, locally advanced, or metastatic Merkel cell carcinoma (MCC)200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated in combination with axitinib, for first-line treatment of patients with advanced renal cell carcinoma (RCC)Pembrolizumab 200 mg IV q3Weeks OR 400 mg q6Weeks, PLUSContinue until disease progression, unacceptable toxicity, or for pembrolizumab, up to 24 months in patients without disease progressionWhen axitinib is used in combination with pembrolizumab, consider dose escalation of axitinib above the initial 5 mg dose at ≥6 weeks intervalsRefer also prescribing information for axitinib dosing informationIndicated for recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus in patients with tumors that express PD-L1 (CPS ≥10), who have disease progression after ≥1 prior lines of systemic therapy200 mg IV q3Weeks OR 400 mg q6Weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progressionIndicated in combination with lenvatinib for patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiationContinue until disease progression, unacceptable toxicity, or for pembrolizumab, up to 24 months in patients without disease progressionRefer to the lenvatinib prescribing information for recommended dosing informationIndicated for unresectable or metastatic tumor mutational burden-high (TMB-H) (≥10 mutations/megabase [mut/Mb]) solid tumors in adult and pediatric patients that have progressed following prior treatment and who have no satisfactory alternative treatment optionsContinue until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not incurable by surgery or radiationContinue until disease progression or unacceptable toxicity, or up to 24 months without disease progressionIndicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC)Continue until disease progression, unacceptable toxicity, or up to 24 months Renal impairment (eGFR ≥15 mL/min/1.73 m²): No dosage adjustment requiredIndicated for refractory classical Hodgkin lymphoma (cHL) or relapse after ≥3 prior lines of therapyContinue until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progressionContinue until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for refractory primary mediastinal large B-cell lymphoma (PMBCL), or relapse after ≥2 prior lines of therapyIndicated for treatment of recurrent, locally advanced, or metastatic Merkel cell carcinoma (MCC)Continue until disease progression, unacceptable toxicity, or up to 24 months without disease progressionIndicated for unresectable or metastatic tumor mutational burden-high (TMB-H) (≥10 mutations/megabase [mut/Mb]) solid tumors in adult and pediatric patients that have progressed following prior treatment and who have no satisfactory alternative treatment optionsContinue until disease progression, unacceptable toxicity, or up to 24 months without disease progressionTMB-H indication: Select for treatment based on TMB-H status in tumor specimensMSI-H/dMMR indication: Select for treatment based MSI-H/dMMR status in tumor specimensOwing to the effect of prior chemotherapy on test results for tumor mutation burden (TMB-H), MSI-H, or dMMR in patients with high-grade gliomas is unclear, obtain test for these markers in the primary tumor specimens prior to initiation of temozolomide chemotherapy in patients with high-grade gliomasInformation on FDA-approved tests for the detection of TMB status is available at: All grades of severity are listed unless indicated otherwiseAlkaline phosphatase increased, Grade 3 or 4 (2.6%)Monitor for signs and symptoms of adrenal insufficiency; administer corticosteroids and hormone replacement as clinically indicated; withhold therapy for moderate (Grade 2) adrenal insufficiency and withhold or discontinue for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiencySolid organ transplant rejection reported in postmarketing setting; treatment increases risk of rejection in solid organ transplant recipients; consider benefit of treatment versus risk of possible organ rejectionInfusion-related reactions, including severe and life-threatening reactions, reported; monitor for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and feverHypophysitis reported; monitor for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency)Thyroid disorders can occur; monitor for changes in thyroid function (at the start of treatment, periodically during treatment, and as clinically indicated) and for clinical signs and symptoms of thyroid disordersBased on its mechanism of action, fetal harm may occur when administered to a pregnant woman (see Pregnancy)In two randomized clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality; treatment of patients with multiple myeloma with a PD-1 or PDL1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trialsBased on its mechanism of action, fetal harm may occur when administered to a pregnant womanNo human data available informing the risk of embryo-fetal toxicityNo studies conducted to assess impact of pembrolizumab on milk production or its presence in breast milkInstruct women to discontinue nursing during treatment and for 4 months after final doseA: Generally acceptable.

2001

Contact the applicable plan On April 28, 2020, the Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, Merck) across all … Pembrolizumab exposure was 5.9 times higher in the 10 mg/kg arm. Medically reviewed by Drugs.com. 2001

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