ALIMTA (pemetrexed for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; Langer CJ, et al. Lancet Oncol. ;17(11) Learn how ALIMTA may help treat advanced nonsquamous non-small cell lung cancer. ALIMTA and carboplatin (carbo) is approved by the FDA to be used with an the FDA in combination with carboplatin (another chemotherapy drug) and. Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you. -. Keep this leaflet. You may need to.

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Overall response rate a ORR: Based on high-level evidence eg, randomized controlled trials and there is uniform NCCN consensus that the intervention is appropriate. 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. ALIMTA is indicated as a single agent for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer Inserf whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

ALIMTA® (Pemetrexed) and Pharmacokinetics

ALIMTA is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma MPM whose disease is unresectable or who are otherwise not candidates for curative surgery. ALIMTA is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed.

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ALIMTA can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection.

Packag risk of myelosuppression is increased in patients who do not receive vitamin supplementation. Folic acid and vitamin B 12 supplementation should be continued during treatment and for 21 days after the last dose of ALIMTA as they may reduce the severity of treatment-related hematologic and gastrointestinal toxicities.

Obtain a complete blood count at the beginning of each cycle. Withhold ALIMTA for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation.

Monitor patients for inflammation or blistering in areas of previous radiation treatment. If concomitant ibuprofen use cannot be avoided, monitor patients more frequently for ALIMTA adverse reactions, including myelosuppression, renal, and gastrointestinal toxicity.

Based on findings from animal studies and its mechanism of action, ALIMTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus.

Advise females of reproductive potential to use effective contraception during treatment with ALIMTA and for 6 months after the final dose.

ALIMTA® (pemetrexed): Storage of Unreconstituted Vials

Advise males with female partners of reproductive potential to use effective contraception during treatment with ALIMTA and for 3 months after the final dose.

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Ibuprofen increases exposure AUC of pemetrexed. There is no information regarding the presence of pemetrexed or its alkmta in human milk, the effects on the breastfed infant, or the effects on milk production. Males of Reproductive Potential: It is not known whether these effects on fertility are reversible. Adverse reactions observed in pediatric patients studied were similar to those observed in adults.

Patients apimta Renal Impairment: The incidences of Grade anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: Based on Kaplan-Meier estimation. Go to data for additional indications. Eli Lilly and Company; Langer CJ, et al. Accessed June 27, To view the most recent and complete version of the guidelines, go online to NCCN.

ALIMTA® (pemetrexed): Storage of Unreconstituted Vials

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Scagliotti GV, et al. Indications and Important Safety Information.