Mesothelioma Treatment, Symptoms, MPM -Alimta.com (pemetrexed for injection)

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Treatment for Malignant Pleural Mesothelioma ALIMTA^® (pemetrexed for injection) 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. ALIMTA can suppress bone marrow function, which may cause low blood cell counts. The information presented here will tell you about how ALIMTA works, how it is given, its side effects, and how you can help with your treatment. About Malignant Pleural Mesothelioma What Is ALIMTA? What Do I Need to Know About ALIMTA Treatment? How ALIMTA Is Given Side Effects About Malignant Pleural Mesothelioma About mesothelioma Mesothelial cells line the chest cavity, abdominal cavity, and the cavity around your heart, and cover the outer surface of most of your internal organs. These cells help protect your organs by producing a special lubricating fluid that allows organs to move around. For example, this fluid makes it easier for the lungs to move inside the chest during breathing.¹ The tissue formed by these cells is called mesothelium. A malignant tumor of the mesothelium is called a malignant mesothelioma, or simply mesothelioma. About 75% of mesotheliomas start in the chest cavity. They are known as pleural mesotheliomas.¹ The main risk factor for developing mesothelioma is exposure to asbestos.² Mesothelioma is fairly rare, with an estimated 2,000 to 3,000 new cases each year in the United States. The incidence of mesotheliomas in the United States has slowly decreased since the early 1990s. This decrease was seen in men and has been attributed to changes in workplace exposure to asbestos. In women, the rate of mesothelioma is lower and has been fairly steady for some time.³ Signs and symptoms of MPM⁴ More than half of patients with pleural mesothelioma have pain at the side of the chest or in the lower back. Many report shortness of breath, while fewer have fever, cough, weight loss, sweating, fatigue and trouble swallowing. Other symptoms include hoarseness, swelling of the face and arms, and muscle weakness. Most people with mesothelioma have symptoms a few months before they are diagnosed, although in some people this is longer. If you have been exposed to asbestos and have any of these symptoms, you should see a healthcare team right away. Back to Top What Is ALIMTA? The scientific (or generic) name for ALIMTA is pemetrexed (for injection). ALIMTA is a chemotherapy drug used to treat a certain kind of cancer known as malignant pleural mesothelioma. Chemotherapy consists of treatment with one or more anticancer drugs that kill cancer cells. ALIMTA works by interfering with a crucial process that allows cancer cells to reproduce and spread. Specifically, ALIMTA works by interfering with activity of 3 enzymes that are required to help the cancer grow. 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. ALIMTA can suppress bone marrow function, which may cause low blood cell counts. A clinical trial demonstrated that, when compared to cisplatin alone, ALIMTA plus cisplatin showed results in improving the median survival for patients with MPM.⁵ Back to Top What Do I Need to Know About ALIMTA Treatment? Like many patients, you might wonder what treatment is like. There are several things you'll need to know. You will get your treatment at your doctor's office, a clinic, or a hospital. ALIMTA therapy is given through a needle into one of your veins. This is called an "infusion," and an infusion of ALIMTA takes about 10 minutes. You may also receive another type of chemotherapy treatment at this time. Your doctor will explain the exact type of therapy you will be receiving. 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. For at least 5 of the 7 days before you start taking ALIMTA, you will need to take a folic acid pill (a type of B vitamin) once per day. Your healthcare team will tell you exactly what to take, but make sure that you are taking between 350 and 1,000 micrograms each day. This is the amount that usually is found in a standard multivitamin tablet, which is available over the counter. Ask your healthcare team or pharmacist for help in choosing a folic acid product. You will continue to take a folic acid pill every day until 21 days after your last cycle of ALIMTA. Your healthcare team will give you a shot (into a muscle) of vitamin B₁₂ during the week before you start ALIMTA. Your healthcare team will then give you a shot approximately every 9 weeks, most likely on the same day as you receive your ALIMTA chemotherapy, for the rest of your cycles. To help your healthcare team effectively manage your treatment, make sure you tell them about all of your medical conditions. If you have liver or kidney problems, be sure to tell this to your healthcare team. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. Tell your healthcare team if you are taking other medicines, including prescription or nonprescription medicines, vitamins, and herbal supplements. If you are taking a nonsteroidal anti-inflammatory drug (an NSAID, like ibuprofen, or other drugs used to treat pain and arthritis conditions), you should make sure to tell your healthcare team. Depending on your situation, you may be asked to stop taking these for a period of time. You will be given an oral steroid medication called a corticosteroid to minimize the risk of a skin rash or certain other side effects that can occur with the use of this treatment. Be sure to take this drug twice daily on the day before, the day of, and the day after treatment unless your healthcare team gives you different instructions. You may find it helpful to use a therapy calendar to help keep track of your treatment plan. Use the calendar to mark when you have taken your daily folic acid pill. You may also want to use it to keep track of your appointments, side effects, or information you want to communicate to your healthcare team. There is additional important information on the safety profile and side effects of ALIMTA therapy that you must be aware of. Please see the Important Safety Information for ALIMTA. Back to Top How ALIMTA Is Given ALIMTA should be administered only by a qualified healthcare professional. Your healthcare team will give you ALIMTA by mixing it into a solution and giving it through a needle into a vein — this is called intravenous infusion (IV). Cisplatin will also be administered through an IV. For the treatment of MPM, ALIMTA is given — in combination with cisplatin (another type of chemotherapy) — once every 21 days (3-week treatment cycles). The infusion of ALIMTA will be given on the first day of the treatment cycle and will take about 10 minutes. Cisplatin is then infused over 2 hours beginning approximately 30 minutes after the end of the ALIMTA administration. After these 2 infusions, you will receive no more chemotherapy during this 21-day cycle. These "rest days" are a normal part of your treatment with ALIMTA. As a part of your treatment, you will also receive additional medications, including vitamin B₁₂, folic acid, and corticosteroids. You will have regular blood tests before and during your treatment with ALIMTA. You and your healthcare team will usually decide before each treatment whether you should continue treatment or change dose according to what benefits you have received from previous treatment and what side effects you may have experienced. Your healthcare team may ask you to return for follow-up visits after you receive ALIMTA therapy, so they can monitor how you are doing. If you have questions about how ALIMTA is given, please be sure to discuss them with your healthcare team. Back to Top Side Effects 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 plus cisplatin for MPM. 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 can 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 in combination with cisplatin 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. ALIMTA can suppress bone marrow function, which may cause low blood cell counts. Most patients taking ALIMTA plus cisplatin will have side effects. This section will discuss some of the most frequent and/or most serious side effects associated with ALIMTA plus cisplatin for the treatment of patients with MPM who are not candidates for surgery. Sometimes it is not always possible to tell whether ALIMTA, cisplatin, 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. 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. 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. 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^6,7 Before and during your treatment with ALIMTA plus cisplatin, 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 that may reduce a fever that can be given along with chemotherapy. If you have a fever of 100.5°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 plus cisplatin. 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 treatment⁸: 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 References: American Cancer Society. What Is Malignant Mesothelioma? Atlanta, GA: American Cancer Society; updated June 16, 2011. Available at: http://www.cancer.org/Cancer/MalignantMesothelioma/DetailedGuide/malignant-mesothelioma-malignant-mesothelioma. Accessed June 16, 2011. American Cancer Society. What Are the Risk Factors for Malignant Mesothelioma? Atlanta, GA: American Cancer Society; updated June 16, 2011. Available at: http://www.cancer.org/Cancer/MalignantMesothelioma/DetailedGuide/malignant-mesothelioma-risk-factors. Accessed June 16, 2011. American Cancer Society. What Are the Key Statistics About Malignant Mesothelioma? Atlanta, GA: American Cancer Society; updated June 16, 2011. Available at: http://www.cancer.org/Cancer/MalignantMesothelioma/DetailedGuide/malignant-mesothelioma-key-statistics. Accessed June 16, 2011. American Cancer Society. How Is Malignant Mesothelioma Diagnosed? Atlanta, GA: American Cancer Society; updated June 16, 2011. Available at: http://www.cancer.org/Cancer/MalignantMesothelioma/DetailedGuide/malignant-mesothelioma-diagnosed. Accessed June 16, 2011. J Clin Oncol. 2003;21(14):2640. 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