c 0.25 = 9.3 mos ...... _ <ii ,_ .2: 2: 0.00 ::::, en 0 5 10 15 20 25 30 Survival Time (months) ALIMTA + Cisplatin (n=226) --- Cisplatin (n=222) 21 ALIMTA, pemetrexed for injection, is available in sterile single-use vials containing 100 mg pemetrexed. NDC 0002-7640-01 (VL7640): single-use vial with ivor y flip-off cap individually packaged in a carton. ALIMTA, pemetrexed for injection, is available in sterile single-use vials containing 500 mg pemetrexed. NDC 0002-7623-01 (VL7623): single-use vial with ivor y flip-off cap individually packaged in a carton. 16.2 Storage and Handling ALIMTA, pemetrexed for injection, should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Chemical and physical stability of reconstituted and infusion solutions of ALIMTA were demonstrated for up to 24 hours following initial reconstitution, when stored refrigerated, 2-8°C (36-46°F), or at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives. Discard unused portion [see Dosage and Administration (2.5)] . ALIMTA is not light sensitive. 17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (PPI)Patients should be instructed to read the patient package insert carefully. 17.1 Need for Folic Acid and Vitamin B 12 Patients treated with ALIMTA must be instructed to take folic acid and vitamin B 12as a prophylactic measure to reduce treatment-related hematologic and gastrointestinal toxicity [see Dosage and Administration (2.3)] . 17.2 Low Blood Cell Counts Patients should be adequately informed of the risk of low blood cell counts and instructed to immediately contact their physician should any sign of infection develop including fever. Patients should also contact their physician if bleeding or sym ptoms of anemia occur. 17.3 Gastrointestinal Effects Patients should be instructed to contact their physician if persistent vomiting, diarrhea, or signs of dehydration appear. 17.4 Concomitant Medications Patients should be instructed to inform the physician if they are taking any concomitant prescription or over-the-counter medications including those for pain or inflammation such as non-steroidal anti-inflammatory drugs [see Drug Interactions (7.1)] . Literature revised December 19, 2011 Lilly USA, LLC Indianapolis, IN 46285, USA Copyright © 2004, 2011, Eli Lilly and Company.