General: Patient Selection: For treatment of Non-Small Cell Lung Carcinoma or Gastric Cancer as Monotherapy: Patients should be selected for treatment of advanced NSCLC with Pembrolizumab (KEYTRUDA) based on the presence of positive PD-L1 expression (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). Patients should be selected for treatment of recurrent locally advanced or metastatic gastric cancer with Pembrolizumab (KEYTRUDA) based on the presence of positive PD-L1 expression (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). If PD-L1 expression is not detected in an archival gastric cancer specimen, obtain a tumor biopsy for PD-L1 testing, if feasible.
Recommended Dosing: Pembrolizumab (KEYTRUDA) is administered as an intravenous infusion over 30 minutes every 3 weeks.
The recommended dose of Pembrolizumab (KEYTRUDA) is: 200 mg for head and neck cancer, classical Hodgkin Lymphoma, urothelial carcinoma, gastric cancer, or previously untreated NSCLC as monotherapy.
200 mg for NSCLC in combination therapy.
2 mg/kg for melanoma or previously treated NSCLC as monotherapy.
When administering Pembrolizumab (KEYTRUDA) as part of a combination with pemetrexed and carboplatin, Pembrolizumab (KEYTRUDA) should be administered first. See also the prescribing information for pemetrexed and carboplatin.
Patients should be treated with Pembrolizumab (KEYTRUDA) until disease progression or unacceptable toxicity. Atypical responses (i.e., an initial transient increase in tumor size or small new lesions within the first few months followed by tumor shrinkage) have been observed. Clinically stable patients with initial evidence of disease progression should remain on treatment until disease progression is confirmed.
Dose Modifications: (See Table 13.)
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Pediatric Patients: Safety and efficacy of Pembrolizumab (KEYTRUDA) in children below 18 years of age have not yet been established.
Geriatric Patients: No overall differences in safety or efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years). No dose adjustment is necessary in this population.
Renal Impairment: No dose adjustment is needed for patients with mild or moderate renal impairment. Pembrolizumab (KEYTRUDA) has not been studied in patients with severe renal impairment.
Hepatic Impairment: No dose adjustment is needed for patients with mild hepatic impairment. Pembrolizumab (KEYTRUDA) has not been studied in patients with moderate or severe hepatic impairment.
For the adjuvant therapy treatment of melanoma, administer for up to one year or until disease recurrence or unacceptable toxicity.