#高警訊藥品

抗腫瘤劑
Head and neck cancer, squamous cell(recurrent or metastatic):
1. (First-line) In combination with fluorouracil(FU) and platinum.
2. (First-line) Single use in patients whose tumors express PD-L1 (CPS 1), as determined by an approved test.
3. Single use in patients whose tumors express PD-L1 (CPS 1), as determined by an approved test,<20201214> and are on or after platinum-containing chemotherapy.
Endometrial carcinoma(advanced):
Treatment of carcinoma (in combination with lenvatinib) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.<20201214>

Anti-PD-1 Monoclonal Antibody (Immune Checkpoint Inhibitor)
Pembrolizumab inhibits programmed cell death-1 (PD-1) activity by binding to the PD-1 receptor on T-cells to block PD-1 ligands (PD-L1 and PD-L2) from binding and induce antitumor responses

Distribution:
Vdss: 6 L
Pharmacodynamics:
1. Half-life elimination: 22 days
2. Clearance: (First dose) 252 mL/day; (steady state) 195 mL/day

Hypersensitivity to pembrolizumab or any component of the formulation

May cause fetal harm if administered during pregnancy; verify pregnancy status prior to initiation of treatment in females

The manufacturer recommends that breastfeeding be discontinued during therapy and for 4 months following the final pembrolizumab dose.

Administration:
1. Do not infuse other medications through the same infusion line
2. Infuse over 30 minutes; interrupt or slow the infusion for grade 1 or 2 infusion-related reactions, permanently discontinue for grade 3 or 4 infusion-related reactions
Dosage:
200 mg once every 3 weeks for 8 doses or 400 mg once every 6 weeks; for 4 doses (up to 24 months) or until disease progression or unacceptable toxicity

No dosage reductions of pembrolizumab are recommended; treatment is withheld or discontinued to manage toxicities.

No dosage adjustment necessary. (In a pharmacokinetic study, no difference in clearance was noted for patients with eGFR ≥15 mL/minute/1.73 m2)

Hepatic impairment prior to treatment initiation:
1. Mild (total bilirubin ≤ULN and AST > ULN or total bilirubin >1 to 1.5 × ULN and any AST): No dosage adjustment necessary
2. Moderate (total bilirubin >1.5 to 3 × ULN and any AST) to severe (total bilirubin >3 × ULN and any AST) : Has not been studied
Hepatotoxicity during treatment:
administer systemic corticosteroids (1 to 2 mg/kg/day prednisone [or equivalent]) or other appropriate therapy for immune-mediated adverse reactions until improvement to grade 1 or lower, then follow with a corticosteroid taper.

The diluted KEYTRUDA solution can be stored in:
1. Refrigerated at 2°C to 8°C, return to room temperature before administration: do not exceed 24 hours
2. At room temperature: do not exceed 6 hours (includes the time in the IV bag and the time required for the infusion)
3. Never freeze