NEW
Keytruda健痊得

Keytruda Dosage/Direction for Use

pembrolizumab

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Patient Selection for NSCLC, Urothelial Carcinoma, or MSI-H or dMMR Cancer: 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 [see Pharmacology: Clinical Studies: Non-Small Cell Lung Cancer under Actions]; metastatic NSCLC [see Pharmacology: Clinical Studies: Non-Small Cell Lung Cancer under Actions]; metastatic urothelial carcinoma [see Pharmacology: Clinical Studies: Urothelial Carcinoma 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: Microsatellite Instability-High or Mismatch Repair Deficient Cancer under Actions].
Because the effect of prior chemotherapy on test results for 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.
Recommended Dosage: See Table 17.

Click on icon to see table/diagram/image

Dose Modifications: No dose reductions of KEYTRUDA are recommended. Withhold or discontinue KEYTRUDA to manage adverse reactions as described in Table 18. (See Table 18.)

Click on icon to see table/diagram/image

In patients with RCC being treated with KEYTRUDA in combination with axitinib: If ALT or AST ≥3 times ULN but <10 times ULN without concurrent total bilirubin ≥2 times ULN, withhold both KEYTRUDA and axitinib until these adverse reactions recover to Grades 0-1. Consider corticosteroid therapy. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
If ALT or AST ≥10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN, permanently discontinue both KEYTRUDA and axitinib and consider corticosteroid therapy.
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.
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