#高警訊藥品

間皮瘤、非小細胞肺癌
Malignant pleural mesothelioma:
Initial treatment of malignant pleural mesothelioma (in combination with cisplatin) that is unresectable
Non–small cell lung cancer, nonsquamous:
1. Initial treatment of locally advanced or metastatic nonsquamous NSCLC (in combination with cisplatin); in patients with no EGFR or ALK genomic tumor aberrations (in combination with platinum chemotherapy and pembrolizumab)
2. Maintenance treatment of nonsquamous NSCLC if no progression after 4 cycles of platinum-based therapy (single-agent)

Limitation of use: Not indicated for the treatment of squamous cell NSCLC

Antineoplastic Agent, Antimetabolite
Pemetrexed is an antifolate containing the pyrrolopyrimidine-based nucleus, which exerts its antineoplastic activity by disrupting folate-dependent metabolic processes essential for cell replication.

Distribution:
1. Vdss: 16.1 L
2. Protein binding: 81%
Metabolism:
Minimal; Half-life elimination: 3.5 hours
Excretion:
Urine (70% to 90% as unchanged drug)

1. Severe hypersensitivity to pemetrexed or any component of the formulation
2. Concomitant yellow fever vaccine

X

The manufacturer recommends that nursing be stopped if a breastfeeding woman is to receive Pemetrexed, due to the possibility for adverse events in the newborn..

Anemia, diarrhea, fever, infectious disease, leukopenia, neutropenia, peeling of skin, pharyngitis, rash, shivering, stomatitis, thrombocytopenic disorder.

Malignant pleural mesothelioma:
1. Dose: IV; 500 mg/m² on day 1 of each 21-day cycle (in combination with cisplatin)
2. Cycle: The American Society of Clinical Oncology guidelines for malignant pleural mesothelioma recommend first-line platinum/pemetrexed-based therapy for 4 to 6 cycles
Non–small cell lung cancer, nonsquamous:
Initial treatment of locally advanced or metastatic NSCLC:
500 mg/m² on day 1 of each 21-day cycle (in combination with cisplatin) for up to 6 cycles or until disease progression or unacceptable toxicity.
Initial treatment of metastatic NSCLC:
500 mg/m² on day 1 of each 21-day cycle (in combination with pembrolizumab and either carboplatin or cisplatin) for 4 cycles; following platinum-based therapy, may continue pemetrexed (alone or with pembrolizumab) as maintenance therapy until disease progression or unacceptable toxicity.
Maintenance treatment of locally advanced or metastatic NSCLC (after 4 cycles of initial platinum-based therapy):
500 mg/m² on day 1 of each 21-day cycle (single-agent); continue until disease progression or unacceptable toxicity.
Second-line treatment of recurrent/metastatic disease (after prior chemotherapy):
500 mg/m² on day 1 of each 21-day cycle (single-agent); continue until disease progression or unacceptable toxicity.

Depending on renal function estimated by Cockcroft-Gault formula:
1. CrCl ≥45 mL/minute: No dosage adjustment necessary
2. CrCl <45 mL/minute: Use is not recommended by the manufacturer
Renal toxicity during treatment:
Withhold pemetrexed until CrCl is ≥45 mL/minute
Concomitant ibuprofen use:
1. CrCl ≥80 mL/minute: No dosage adjustment necessary
2. CrCl 45-79 mL/minute: Avoid ibuprofen for 2 days before, the day of, and for 2 days following a dose of pemetrexed. Monitor more frequently for myelosuppression, renal, and GI toxicities if concomitant ibuprofen administration cannot be avoided

There are no dosage adjustments provided in the manufacturer's labeling; however, elevated AST, AST, or total bilirubin do not appear to affect pemetrexed pharmacokinetics.

1. Dilute the appropriate volume of reconstituted solution to a total volume of 100 mL with preservative-free NS; do not use diluents containing calcium, including LR and Ringer injection.
2. Store reconstituted vial or diluted solution under refrigeration for less than 24 hours.