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Prescribing Information for GEMZAR | Safety Information for GEMZAR | Prescribing Information for ALIMTA  | Safety Information for ALIMTA Privacy Statement | Terms of Use Copyright © 2008 Eli Lilly and Company. All rights reserved. This site is intended for U.S. residents age 18 and over. For more information about cancer, contact your doctor or other healthcare professional. GEMZAR® is a registered trademark of Eli Lilly and Company. ALIMTA® is a registered trademark of Eli Lilly and Company. MG28487 About ALIMTA ALIMTA in combination with cisplatin is indicated for the treatment of patients with Malignant Pleural Mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ALIMTA as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a clinical benefit, such as a favorable survival effect or improvement of disease-related symptoms. Important Safety Information for ALIMTA Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy. Contraindication ALIMTA is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed or to any other ingredient used in the formulation. Warnings ALIMTA should not be administered to patients with a creatinine clearance <45 mL/min. One patient with severe renal impairment (creatinine clearance 19 mL/min) who did not receive folic acid and vitamin B12 died of drug-related toxicity following administration of ALIMTA alone. ALIMTA can suppress bone marrow function, as manifested by neutropenia, thrombocytopenia, and anemia (or pancytopenia). Patients must be instructed to take folic acid and vitamin B12 with ALIMTA as a prophylaxis to reduce treatment-related hematologic and GI toxicities. Pregnancy Category D—ALIMTA may cause fetal harm when administered to a pregnant woman. Precautions Complete blood cell counts, including platelet counts and periodic chemistry tests, should be performed on all patients receiving ALIMTA. Patients should not begin a new cycle of treatment unless the ANC is ≥ 1500 cells/mm3 and the platelet count is ≥ 100,000 cells/mm3 and creatinine clearance is ≥ 45 mL/min. Pretreatment with dexamethasone or its equivalent has been reported to reduce the incidence and severity of skin rash. The effect of third space fluid, such as pleural effusion and ascites, on ALIMTA is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to ALIMTA administration. Concomitant administration of nephrotoxic drugs or substances that are tubularly secreted could result in delayed clearance of ALIMTA. Caution should be used when administering ibuprofen concurrently with ALIMTA to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of ALIMTA. In the absence of data regarding potential interaction between ALIMTA and NSAIDs with longer half-lives, all patients taking these NSAIDs should interrupt dosing for at least 5 days before, the day of, and 2 days following ALIMTA administration. If concomitant administration of an NSAID is necessary, patients should be monitored closely for toxicity, especially myelosuppression, renal and gastrointestinal toxicities. It is recommended that nursing be discontinued if the mother is being treated with ALIMTA. ALIMTA should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Dose adjustments may be necessary in patients with hepatic insufficiency. Dosing and Modification Guidelines Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum nonhematologic toxicity from the preceding cycle of therapy. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information. Abbreviated Adverse Events (% incidence) The most common adverse events (grades 3/4) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, for the treatment of patients with MPM were neutropenia (24 vs 4); leukopenia (16 vs 1); anemia (6 vs 0); thrombocytopenia (5 vs 0); infection without neutropenia (2 vs 0); infection with grade 3/4 neutropenia (1 vs 0); infection/febrile neutropenia — other (1 vs 0); febrile neutropenia (1 vs 0); fatigue (17 vs 13); thrombosis/embolism (6 vs 4); nausea (12 vs 6); vomiting (11 vs 5); dyspnea (11 vs 7); and chest pain (9 vs 6). The most common clinically relevant adverse events (all grades) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, were neutropenia (58 vs 16); leukopenia (55 vs 20); anemia (33 vs 14); thrombocytopenia (27 vs 10); fatigue (80 vs 74); thrombosis/embolism (7 vs 4); nausea (84 vs 79); vomiting (58 vs 52); constipation (44 vs 39); anorexia (35 vs 25); stomatitis/pharyngitis (28 vs 9); diarrhea (26 vs 16); dyspnea (66 vs 62); chest pain (40 vs 30); and rash (22 vs 9). The most common adverse events (grades 3/4) with ALIMTA versus docetaxel, respectively, for the treatment of patients with NSCLC were anemia (8 vs 7); leukopenia (5 vs 28); neutropenia (5 vs 40); thrombocytopenia (2 vs 1); ALT elevation (3 vs 1); febrile neutropenia (2 vs 13); infection without neutropenia (6 vs 4); infection/febrile neutropenia — other (2 vs 1); fatigue (16 vs 17); thrombosis/embolism (3 vs 3); cardiac ischemia (3 vs 1); anorexia (5 vs 8); dyspnea (18 vs 26); and chest pain (7 vs 8). The most common clinically relevant adverse events (all grades) with ALIMTA versus docetaxel, respectively, were fatigue (87 vs 81); anorexia (62 vs 58); nausea (39 vs 25); constipation (30 vs 23); vomiting (25 vs 19); diarrhea (21 vs 34); stomatitis/pharyngitis (20 vs 23); edema (19 vs 24); dyspnea (72 vs 74); chest pain (38 vs 32); neuropathy/sensory (29 vs 32); infection without neutropenia (23 vs 17); anemia (33 vs 33); fever (26 vs 19); and rash (17 vs 9). See complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information for safety and dosing guidelines. About GEMZAR GEMZAR in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. GEMZAR is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer. GEMZAR is indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is indicated for patients previously treated with 5-FU. GEMZAR in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Important Safety Information for GEMZAR Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy. Contraindication Known hypersensitivity to GEMZAR. Warnings Infusion times of GEMZAR longer than 60 minutes and more frequent than weekly dosing have been shown to increase toxicity. Pulmonary toxicity has been reported. In cases of severe lung toxicity, GEMZAR therapy should be discontinued immediately and appropriate supportive care measures instituted. Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of GEMZAR. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS. Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving GEMZAR alone or in combination with other potentially hepatotoxic drugs. GEMZAR is Pregnancy Category D. GEMZAR can cause fetal harm when administered to a pregnant woman. Precautions Use caution in patients with pre-existing renal impairment or hepatic insufficiency. Administration of GEMZAR may exacerbate underlying hepatic insufficiency. The optimum regimen for safe administration of GEMZAR with therapeutic doses of radiation has not yet been determined in all tumor types. GEMZAR has radiosensitizing activity and radiation recall reactions have been reported. It is not known whether GEMZAR or its metabolites are excreted in human milk. The effectiveness of GEMZAR in pediatric patients has not been demonstrated. The toxicities of GEMZAR observed in pediatric patients were similar to those reported in adults. GEMZAR clearance is affected by age as well as gender. Patients receiving therapy with GEMZAR should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Monitoring and Dosage Modifications Dosage adjustments for hematologic toxicity may be required. Serum creatinine, potassium, calcium, and magnesium should be monitored during combination therapy with cisplatin. Patients should be assessed with a CBC, including differential and platelet count, prior to each dose of GEMZAR. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information. Hepatic and renal function (including transaminases and serum creatinine) should be evaluated prior to therapy with GEMZAR and periodically thereafter. Abbreviated Adverse Events (% Incidence) The most severe adverse events (grades 3/4) with GEMZAR plus paclitaxel versus paclitaxel, respectively, for the treatment of patients with MBC were neutropenia (48 vs 11); alopecia (18 vs 22); leukopenia (11 vs 2); anemia (7 vs 4); fatigue (7 vs 2); thrombocytopenia (6 vs 2); ALT elevation (6 vs 1); and neuropathy-sensory (6 vs 3). The most common adverse events (all grades) were alopecia (90 vs 92); anemia (69 vs 51); neutropenia (69 vs 31); neuropathy-sensory (64 vs 58); nausea (50 vs 31); fatigue (40 vs 28); myalgia (33 vs 33); vomiting (29 vs 15); and thrombocytopenia (26 vs 7). The most severe adverse events (grades 3/4) with GEMZAR plus cisplatin for the first-line treatment of patients with NSCLC in comparative trials of a 28-day regimen (GEMZAR plus cisplatin versus cisplatin alone) and a 21-day regimen(GEMZAR plus cisplatin versus etoposide plus cisplatin), respectively, were neutropenia (57 vs 4, 64 vs 76); thrombocytopenia (50 vs 4, 55 vs 13); leukopenia (46 vs 3, 29 vs 43); anemia (25 vs 7, 22 vs 15); nausea 28d (27 vs 21); vomiting 28d (23 vs 19); nausea/vomiting 21d (39 vs 26); neuromotor 28d (12 vs 3); hypomagnesemia 28d (7 vs 2); neurohearing 28d (6 vs 6); creatinine elevation 28d (5 vs 3); and dyspnea (7 vs 5, 1 vs 0). The most common adverse events (all grades) of the 28-day regimen (GEMZAR plus cisplatin versus cisplatin alone) and the 21-day regimen (GEMZAR plus cisplatin versus etoposide plus cisplatin), respectively, were anemia (89 vs 67, 88 vs 77); leukopenia (82 vs 25, 86 vs 87); neutropenia (79 vs 20, 88 vs 87), thrombocytopenia (85 vs 13, 81 vs 45), lymphocytopenia 28d (75 vs 51); hematuria (15 vs 13, 22 vs 10); creatinine 28d (38 vs 31), hyperglycemia 28d (30 vs 23); hypomagnesemia 28d (30 vs 17); nausea 28d (93 vs 87); vomiting 28d (78 vs 71); nausea and vomiting 21d (96 vs 86); alopecia (53 vs 33, 77 vs 92); neuromotor 28d (35 vs 15); constipation (28 vs 21, 17 vs 15); neurohearing 28d (25 vs 21); paresthesias 21d (38 vs 16); and infection (18 vs 12, 28 vs 21). The most severe adverse events (grades 3/4) with GEMZAR versus 5-FU for the first-line treatment of patients with pancreatic cancer and data reported from a single agent safety database, respectively, were neutropenia (26 vs 5, 24); alkaline phosphatase elevation (16 vs 17, 20); AST elevation (12 vs 2, 17); nausea/vomiting (13 vs 5, 12); ALT elevation (10 vs 0, 11); anemia (10 vs 0, 10); leukopenia (10 vs 2, 9); thrombocytopenia (10 vs 2, 8); bilirubin elevation (4 vs 9, 8); and pain (2 vs 0, 7). The most common adverse events (all grades), defined as reported in < 25% of patients, were AST elevation (72 vs 52, 78); alkaline phosphatase elevation (71 vs 64, 77); anemia (65 vs 45, 73); ALT elevation (72 vs 38, 72); leukopenia (71 vs 15, 64); nausea and vomiting (64 vs 58, 71); neutropenia (62 vs 18, 61); thrombocytopenia (47 vs 15, 36); pain (10 vs 7, 42); fever (30 vs 16, 38); proteinuria (10 vs 2, 32); constipation (10 vs 11, 31); diarrhea (24 vs 31, 30); rash (24 vs 13, 28); and bilirubin elevation (16 vs 25, 26). The most severe adverse events (grades 3/4) with GEMZAR plus carboplatin versus carboplatin, respectively, for the treatment of patients with advanced ovarian cancer were neutropenia (71 vs 12), thrombocytopenia (35 vs 11), leukopenia (53 vs 7), anemia (28 vs 11), nausea (6 vs 3), vomiting (6 vs 3), and constipation (7 vs 3). The most common adverse events (all grades) were neutropenia (90 vs 58); leukopenia (86 vs 70); anemia (86 vs 75); and thrombocytopenia (78 vs 57); RBC transfusion (38 vs 15), alopecia (49 vs 17), neuropathy/sensory (29 vs 27), nausea (69 vs 61), fatigue (40 vs 32), vomiting (46 vs 36), diarrhea (25 vs 14), and constipation (42 vs 37). See complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information for safety and dosing guidelines. SG-22