About Advanced Nonsquamous NSCLC - Alimta.com (pemetrexed for injection)

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About Lung Cancer About Lung Cancer Two Categories of Lung Cancer Signs and Symptoms of Lung Cancer About Lung Cancer Lung cancer begins in the lungs, where cells multiply at a very fast rate to form "tumors" that invade and destroy normal tissue. These cancer cells sometimes spread from one or both lungs to other parts of the body. That process is known as "metastasis." Approximately 350,000 people in the United States are living with lung cancer at any given time.¹ Fortunately, the number of new lung cancer cases and deaths reported in recent years is going down due to less smoking. But lung cancer is the most common cancer in the world.² In the United States, 85% of lung cancer cases are NSCLC.³ ALIMTA^® (pemetrexed for injection) 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. Back to Top Two Categories of Lung Cancer The two main categories of lung cancer are non-small cell lung cancer (also known by its initials as "NSCLC") and small cell lung cancer (SCLC). The difference between non-small cell and small cell lung cancer has to do with the kind of cancer cells, how quickly the cancer cells grow, and how each kind of cancer cell responds to treatment. Back to Top Signs and Symptoms of Lung Cancer⁴ Lung cancer symptoms usually occur when the cancer has progressed to an advanced stage. But seeing your healthcare team when you first notice symptoms might enable your cancer to be diagnosed and treated while still in a curable stage. Early detection can improve the likelihood that treatment can extend your life. Although the symptoms listed here can have many causes, it is important for you to see your healthcare team as soon as possible, just in case. The most common symptoms of lung cancer are: Chest pain that may feel worse with coughing or laughing, or even deep breathing Bloody or rust-colored spit or phlegm Loss of appetite and weight loss Cough that does not go away Wheezing Shortness of breath Infections, like pneumonia or bronchitis, which continue to come back Hoarseness Symptoms that lung cancer may have spread to distant organs include: Limb weakness or numbness, dizziness, headache, or seizure Pain in the bones Lumps near the surface of the body Jaundice (yellowing of the skin and eyes) Remember to contact your healthcare team if you have any of these symptoms so the cause can be found and treated, if needed. 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: Cancer Support Community. Understanding Lung Cancer. Available at: http://52.f2bed1.client.atlantech.net/mm/Learn-About /cancertype/lungcancer/Undertstanding-Lung-Cancer.aspx. Accessed December 6, 2011. J Clin Oncol. 2006;24:2137-2150. American Cancer Society. Lung Cancer (Non-Small Cell). Atlanta, GA: American Cancer Society; updated September 15, 2011. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed September 15, 2011. American Cancer Society. How is non-small cell lung cancer diagnosed? Atlanta, GA: American Cancer Society; updated September 15, 2011. Available at: http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung- cancer-diagnosis. Accessed September 15, 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