Generic Name and Formulations:
Pemetrexed 100mg/vial, 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Lilly, Eli and Company
Indications for ALIMTA:
Locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC): in combination with cisplatin as initial treatment, or as a single agent for maintenance in patients whose disease has not progressed after 4 cycles of platinum-based 1st-line chemotherapy. Treatment of patients with recurrent, metastatic nonsquamous, NSCLC after prior chemotherapy, as a single agent. Initial treatment of metastatic, nonsquamous NSCLC, in combination with carboplatin and pembrolizumab. Malignant pleural mesothelioma (MPM): in combination with cisplatin, for the initial treatment of patients whose disease is either unresectable or who are otherwise not candidates for curative surgery.
Limitations Of use:
Not for the treatment of squamous cell NSCLC.
Supplement with oral folic acid and intramuscular vitamin B12 one week prior to 1st pemetrexed dose, continue during treatment, and for 21 days after the last dose. Pretreat with dexamethasone for 3 consecutive days, beginning the day before each pemetrexed dose. In combination regimens: give pemetrexed dose prior to cisplatin or carboplatin. CrCl ≥45mL/min: 500mg/m2 by IV infusion over 10mins on Day 1 of each 21-day cycle. In combination with cisplatin for NSCLC: treat for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Maintenance, recurrent NSCLC, or MPM: continue until disease progression or unacceptable toxicity. In combination with carboplatin and pembrolizumab: treat for 4 cycles; thereafter, may give pemetrexed as maintenance with or without pembrolizumab until disease progression or unacceptable toxicity. Dose modifications: see full labeling.
See full labeling. Increased risk of myelosuppression without vitamin supplementation. Permanently discontinue if Grade 3 or 4 neurologic toxicity, recurrent Grade 3 or 4 non-hematologic toxicity after two dose reductions, severe/life-threatening skin toxicity, interstitial pneumonitis, or signs of radiation recall occur. Do not start a treatment cycle unless ANC is ≥1500cells/mm3, platelets ≥100,000cells/mm3. Monitor CBCs, platelets, renal function. Renal impairment (CrCl <45mL/min). Severe third space fluid. Embryo-fetal toxicity. Pregnancy; avoid. Use effective contraception during and for 6 months (females) or 3 months (males) after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).
Increased risk of toxicity with concomitant ibuprofen in renal impairment (CrCl 45–79mL/min): avoid for 2 days before, the day of, and 2 days following pemetrexed dose; if unavoidable, monitor more frequently for effects.
Fatigue, nausea, anorexia, vomiting, stomatitis/pharyngitis, constipation, rash/desquamation, neutropenia, anemia, thrombocytopenia, dyspnea, diarrhea, headache, decreased appetite; rare: renal failure.
Testing considerations: TS (thymidylate synthase) expression for response and toxicity.
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