1
INDICATIONS AND USAGE
1.1. Non-Squamous Non-Small Cell Lung Cancer (NSCLC) PEMETREXED is indicated:
• in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non-small cell lung cancer (NSCLC).
• in combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic, non-squamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non squamous, NSCLC after prior chemotherapy.
• Limitations of use: PEMETREXED is not indicated for the treatment of patients with squamous cell, nonsmall cell lung cancer.
1.2. Mesothelioma:
PEMETREXED in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unrespectable or who are otherwise not candidates for curative surgery.
2
DOSAGE AND ADMINISTRATION
• The recommended dose of PEMETREXED when administered with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/ min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
• The recommended dose of PEMETREXED for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum based first-line chemotherapy.
• The recommended dose of PEMETREXED for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. The recommended dose of PEMETREXED when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft- Gault equation) of 45 mL/min or greater is 500 mg/m² administered a s a n intravenous infusion over 1 0minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Following completion of platinum based therapy, PEMETREXED may be administered as maintenance therapy, alone or with pembrolizumab, until disease progression or unacceptable toxicity. Pembrolizumab should be administered prior to PEMETREXED when given on the same day. Please refer to the full prescribing information for pembrolizumab and for carboplatin.
5
COMPATIBILITY
5.1. Stability:
PEMETREXED for Injection, is stable in D5W, NS.
PEMETREXED physically incompatible with calcium containing products, including Ringer’s and lactated Ringer’s injection.
5.2. Y-site administration:
Compatible: Acyclovir, amifostine, amikacin, aminophylline, ampicillin, ampicillin/sulbactam, aztreonam, bumetanide, buprenorphine, butorphanol, carboplatin, cefuroxime, cimetidine, cisplatin, clindamycin, cyclophosphamide, cytarabine, dexamethasone sodium phosphate, dexrazoxane, diphenhydramine, docetaxel, dopamine, enalaprilat, famotidine, fluconazole, fluorouracil, ganciclovir, granisetron, haloperidol, heparin, hydromorphone, hydroxyzine, ifosfamide, leucovorin calcium, lorazepam, mannitol, meperidine, mesna, methylprednisolone sodium succinate, metoclopramide, morphine, paclitaxel, potassium chloride, promethazine, ranitidine, sodium bicarbonate, ticarcillin/clavulanate potassium, trimethoprim/sulfamethoxazole, vancomycin, vinblastine, vincristine, zidovudine.
Incompatible: Amphotericin B, calcium gluconate, cefazolin, cefotaxime, cefotetan, cefoxitin, ceftazidime, chlorpromazine, ciprofloxacin, dobutamine, doxorubicin, doxycycline, droperidol, gemcitabine, gentamicin, irinotecan, metronidazole, minocycline, mitoxantrone, nalbuphine, ondansetron, prochlorperazine edisylate, tobramycin, topotecan.
Variable (consult detailed reference): Ceftriaxone.