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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 is a type of chemotherapy. ALIMTA was approved by the FDA as a single agent (used alone) for the treatment of patients with locally advanced or metastatic NSCLC who have already received another chemotherapy agent. The effectiveness of ALIMTA in second-line NSCLC was based on a surrogate endpoint, response rate. There are no controlled trials demonstrating a clinical benefit such as survival effect or an improvement in disease-related symptoms. ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option. Important Safety Information for ALIMTA ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to be pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects. Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling). The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; and rash. Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional. You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition. For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the complete Prescribing Information or call 1-800-545-5979. About GEMZAR GEMZAR in combination with paclitaxel is approved by the FDA for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline. GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible. GEMZAR is indicated as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy). GEMZAR is indicated in combination with carboplatin (another type of chemotherapy) for the woman with ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy. Important Safety Information for GEMZAR GEMZAR may not be appropriate for some patients. If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to be pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby. If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, or herbal supplements. There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection. You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition. For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the complete Prescribing Information, or call 1-800-545-5979. SG-22