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Side Effects: What Should I Expect? General Considerations: Chemotherapy Side effects from chemotherapy are different depending on the type of cancer you have and the combination of drugs given. Side effects may also be different from patient to patient and from treatment to treatment. This section discusses the most frequent or most serious side effects that patients experienced in the clinical trial studying ALIMTA^® (pemetrexed for injection) for NSCLC. Side effects from chemotherapy should be monitored both by you and your healthcare team. Signs and symptoms such as fatigue, nausea, and vomiting are a few examples. Another group of side effects, such as those that change your blood cells, are monitored through regular blood tests, but they can also be identified through signs and symptoms you might experience. Side effects could be serious if not treated. Though a few side effects can be permanent, many are temporary and go away after treatment dose is reduced or stopped. ALIMTA as a Single Agent ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell. ALIMTA can suppress bone marrow function, which may cause low blood cell counts. Most patients taking ALIMTA will have side effects. This section will discuss some of the most common and/or most important side effects associated with ALIMTA when used alone for the treatment of patients with advanced nonsquamous NSCLC who have already received another chemotherapy. Sometimes it is not always possible to tell whether ALIMTA or the cancer itself is causing these side effects, but you should always tell your healthcare team if you are experiencing anything new. Call your healthcare team right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death. Make sure that you follow your healthcare team's instructions regarding your ALIMTA pre-medications. This should help lessen the severity of the side effects you may experience. For more information about all of the side effects noted in the clinical trial of ALIMTA plus cisplatin for NSCLC, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-800-545-5979. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Side effects you and your healthcare team should monitor Additional side effects you'll want to monitor Drug delays and discontinuation When to call your healthcare team Side effects you and your healthcare team should monitor^1,2 Before and during your treatment with ALIMTA, you will have regular blood tests that will monitor you for the following side effects. You may also have symptoms that you must tell your healthcare team about. Low blood cell counts: Low red blood cells Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath. Low white blood cells Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away. Low platelets Low platelets give you a greater chance for bleeding. Back to Top Additional side effects you'll want to monitor Fever Fever may be the first symptom of infection, but it may also be a result of the chemotherapy itself (without infection). There are medications to reduce fever that can be given along with chemotherapy. If you have a fever of 100.4°F or higher, you should call your healthcare team right away. Stomach upset, including nausea, vomiting, diarrhea, or constipation You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms. Tiredness You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor. Mouth, throat, or lip sores (stomatitis, pharyngitis) You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care. Loss of appetite You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you. Rash You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms. Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away. These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Back to Top Talk with your healthcare team As mentioned many times in this website, it is important for you to talk with your healthcare team about any questions or concerns you have as you move through your cancer experience. Drug delays and discontinuation You will have regular blood tests before and during your treatment with ALIMTA. Your healthcare team may adjust your dose of ALIMTA or delay treatment based on the results of your blood tests or your general condition. Side effects may or may not be caused by the drug treatment itself; some effects may be due to the disease or to other reasons. Contact your healthcare team right away if you have fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death. Talk with your healthcare team if you have any side effects that bother you or don't go away. Back to Top When to call your healthcare team You are probably attuned to changes in your body now more than ever. You must never take these changes for granted. As a person living with cancer, you must always be aware of infection. If you suspect an infection of any kind, call your healthcare team immediately. According to the American Cancer Society, you should also alert your healthcare team right away if you notice any other changes in your body or experience any of the following symptoms during your chemotherapy treatment³: A fever of 100.5°F or greater Bleeding or unexplained bruising A rash or allergic reaction such as swelling or severe itching or wheezing Intense chills Pain or soreness at the chemotherapy injection site or catheter site Unusual pain including intense headaches Shortness of breath Long-lasting diarrhea or vomiting Bloody stool or blood in your urine Back to Top Indications and Important Safety Information for ALIMTA^® (pemetrexed for injection) Indications ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell. ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell. ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell. 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 What is the most important information that I should know about ALIMTA? ALIMTA can suppress bone marrow function, which may cause low blood cell counts. 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 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. Your doctor will prescribe a medicine called a “corticosteroid” to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA. 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. You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment. Your doctor will give you vitamin B₁₂ injections while you are getting treatment with ALIMTA. You will get your first vitamin B₁₂ injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment. 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. What should I tell my doctor before receiving ALIMTA? If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA. Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs) for pain or swelling. What are the possible side effects of ALIMTA? Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects. Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death. The most common side effects of ALIMTA when given alone or in combination with cisplatin are: Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms. Low blood cell counts: Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath. Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away. Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA. Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor. Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care. Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you. Rash. You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms. Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away. These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist. How is ALIMTA given? ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks). For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-800-545-5979. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. PM_CON_ISI_All_30NOV2011 Reference: ALIMTA (pemetrexed for injection) [information for patients and caregivers]. Indianapolis, IN: Eli Lilly and Company; 2011. ALIMTA (pemetrexed for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011. American Cancer Society. Understanding Chemotherapy: A Guide for Patients and Families. Atlanta, GA: American Cancer Society; updated March 17, 2011. Available at: http://www.cancer.org/Treatment/TreatmentsandSideEffects/TreatmentTypes/Chemotherapy/ UnderstandingChemotherapyAGuideforPatientsandFamilies/index. Accessed June 2, 2011.

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© 2011 Lilly USA, LLC. ALL RIGHTS RESERVED. This site is intended for U.S. residents age 18 and older. For more information about cancer, contact your doctor or other healthcare professional. ALIMTA^® is a registered trademark of Eli Lilly and Company. MQ75274 11/11