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For Some Cancer Patients on Strong Chemotherapy Neulasta (pegfilgrastim) Supporting your body’s natural defenses against infection ® Strong chemotherapy can reduce the number of white blood cells in your body. This means your immune system isn’t functioning at full strength. FACT What is Neulasta®? Neulasta® is a white blood cell booster, a prescription medication given by an injection under your skin that helps your body make more of its own natural white blood cells to help protect you against chemotherapy-related infection. A low white blood cell count may lead to infection and could result in a hospital stay. White blood cells patrol the bloodstream and attack foreign invaders like bacteria. FACT Neulasta® is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. Studies have shown that Neulasta® is effective in helping to protect certain chemotherapy patients against infections. It has been studied in people with a type of cancer called nonmyeloid, including breast cancer, lung cancer, and lymphomas. How does Neulasta® work? Neulasta® works by stimulating the creation of neutrophils (nu-tro-fils), a type of infection-fighting white blood cell. When you receive Neulasta®, it signals your bone marrow to make more neutrophils. Neulasta® helps support your body’s natural defenses. How is Neulasta® given? Neulasta® is given as an injection under the skin (subcutaneous). You should only receive a dose of Neulasta® on the day your healthcare provider tells you. You should not receive your dose of Neulasta® any sooner than 24 hours after you finish receiving your chemotherapy. What is Neulasta® used for? Neulasta® is a prescription medication that stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. It is used in patients whose cancer medication puts them at risk of developing an infection. How do you know Neulasta® is working? Your doctor will probably order blood tests that will include a neutrophil count. An increase in the number of neutrophils is an indication that Neulasta® is working. Who should not take Neulasta®? Do not take Neulasta® if you have had a serious allergic reaction to Neulasta® (pegfilgrastim) or NEUPOGEN® (filgrastim). What should I tell my healthcare provider before taking Neulasta®? Tell your healthcare provider if you: n Have sickle cell trait or sickle cell disease n Have had severe skin reactions to acrylic adhesives n Are allergic to latex n Have problems with your kidneys n Have any other medical problems n Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby. n Are breastfeeding or plan to breastfeed. It is not known if Neulasta® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are possible serious side effects of Neulasta®? n Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta®. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured. n A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of ARDS: fever, shortness of breath, trouble breathing, or a fast rate of breathing. n Serious Allergic Reactions. Get emergency medical help right away if you get any of these symptoms of a serious allergic reaction with Neulasta®: shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you have an allergic reaction during the delivery of Neulasta®, remove the On-body Injector for Neulasta® by grabbing the edge of the adhesive pad and peeling off the On-body Injector. Get emergency medical help right away. n Sickle Cell Crises. Severe sickle cell crises, and sometimes death, can happen in people with sickle cell trait or disease who receive filgrastim, a medicine similar to Neulasta®. n Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neulasta®. You should notify your healthcare provider right away if you experience puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual. n Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta®. n Capillary Leak Syndrome. Neulasta® can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms: n swelling or puffiness and are urinating less often n trouble breathing n swelling of your stomach-area (abdomen) and feeling of fullness n dizziness or feeling faint n a general feeling of tiredness The most common side effect of Neulasta® is pain in the bones and in your arms and legs. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Neulasta®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‐800‐FDA‐1088 (1‐800‐332‐1088). For more information about Neulasta®, talk with your healthcare provider or pharmacist; go to www.neulasta.com, or call 1-844-696-3852 (1-844-MYNEULASTA). Helping your body make more of its own natural white blood cells What should I do if I experience aching in the bones or muscles? If you experience this side effect, it can usually be relieved with a nonaspirin pain reliever, such as acetaminophen. As with any side effect, always let your doctor or nurse know if you experience aching that is severe and not relieved by over-the-counter medicines. Normal: White blood cells are a key part of your body’s immune system. At normal levels, your white blood cells help protect you from infection. Neutropenia: Strong chemotherapy can reduce the number of white blood cells. This means your immune system isn’t at full strength, which may increase your chances of getting an infection. What other important information do I need to know about receiving Neulasta®? n Make sure your doctor knows about all the medications you are taking before starting Neulasta® injections. n Neulasta® can help reduce the risk of infection, but it may not help reduce the risk of all infections. Talk to your doctor or nurse if you have any questions about Neulasta®. What is the most common side effect of Neulasta®? The most common side effect of Neulasta® is pain in the bones and in your arms and legs. What should I expect if I experience aching in the bones or muscles? Some patients reported experiencing severe aching in the bones or muscles; however, most patients have reported the pain as mild to moderate. While not every patient will experience aching in the bones or muscles, it is most frequently reported as occurring in the first cycle of chemotherapy and is reported less frequently in later cycles of chemotherapy. + - Neulasta® signals the bone marrow to produce more white blood cells. Fever is one of the first symptoms of infection. Call your doctor or nurse right away if you have a fever higher than 100.4°F (38°C). One of the most common side effects of strong chemotherapy is a decreased number of white blood cells. Without enough white blood cells, you may be at risk for developing a serious infection. Immediately report these symptoms of infection to your doctor or nurse: n Fever n Chills or sweating n Mouth ulcers or sores in the throat or around the rectum n Cough or sore throat n Redness, swelling, or sores on the skin n Loose stools or diarrhea for longer than 24 hours Information and support for you and your caregivers Amgen provides many informational resources for patients and their caregivers, including information about financial assistance. Ask your nurse about these resources and visit www.neulasta.com. If you have any questions about this information, be sure to discuss them with your doctor. 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. For more information, please refer to the accompanying Neulasta® prescribing information, or visit www.neulasta.com. © 2015 Amgen Inc. All rights reserved. USA-003-102671(2) 12-15 www.neulasta.com