Generic Name and Formulations:
Pemetrexed 100mg/vial, 500mg/vial; pwd for IV inj 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 maintenance in patients whose disease has not progressed after 4 cycles of platinum-based 1st-line chemotherapy, as a single agent. Treatment of patients with recurrent, metastatic nonsquamous, NSCLC after prior chemotherapy, as a single agent. 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.
See full labeling. 500mg/m2 by IV infusion over 10 mins on Day 1 of each 21-day cycle. Combination therapy: Give cisplatin beginning 30 mins after pemetrexed infusion. 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. 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 and CrCl ≥45mL/min. Monitor CBCs, platelets, renal and hepatic function. Renal impairment (CrCl <45mL/min). Severe third space fluid. Embryo-fetal toxicity. Pregnancy; avoid. Use effective contraception during treatment 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, fatigue, stomatitis/pharyngitis, constipation, rash/desquamation, neutropenia, anemia, thrombocytopenia, elevated creatinine, sensory neuropathy; rare: renal failure.
Testing considerations: TS (thymidylate synthase) expression for response and toxicity.
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