Keytruda Dosage/Direction for Use

Patient Selection: Patient Selection for Single-Agent Treatment: Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in: stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation; metastatic NSCLC; metastatic urothelial carcinoma; first-line treatment of metastatic or unresectable, recurrent HNSCC; previously treated recurrent locally advanced or metastatic esophageal cancer. [See Pharmacology: Clinical Studies under Actions.]
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens [see Pharmacology: Clinical Studies under Actions].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens [see Pharmacology: Clinical Studies under Actions].
Because 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, it is recommended to test for these markers in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Patient Selection for Combination Therapy: For use of KEYTRUDA in combination with chemotherapy and trastuzumab, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma [see Pharmacology: Clinical Studies under Actions].
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer [see Pharmacology: Clinical Studies under Actions].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MSI or MMR status in tumor specimens [see Pharmacology: Clinical Studies under Actions].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC [see Pharmacology: Clinical Studies under Actions].
Recommended Dosage: See Table 38.

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Dose Modifications: No dose reduction for KEYTRUDA is recommended. In general, withhold KEYTRUDA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue KEYTRUDA for Life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.
Dosage modifications for KEYTRUDA for adverse reactions that require management different from these general guidelines are summarized in Table 39. (See Table 39.)

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The following table represents dosage modifications that are different from those described previously for KEYTRUDA or in the Full Prescribing Information for the drug administered in combination. (See Table 40.)

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Recommended Dose Modifications for Adverse Reactions for KEYTRUDA in Combination with Lenvatinib: When administering KEYTRUDA in combination with lenvatinib, modify the dosage of one or both drugs. Withhold or discontinue KEYTRUDA as shown in Table 39. Refer to lenvatinib prescribing information for additional dose modification information.
Administration: Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.