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BRIEF SUMMARY OF PATIENT PACKAGE INSERT Neulasta® (pegfilgrastim) This brief summary of the patient package insert provides information and instructions for people who will be receiving Neulasta or their caregivers. This brief summary does not tell you everything about Neulasta. You should discuss any questions you have about treatment with Neulasta with your doctor. • Sickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Neulasta. Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, a medicine similar to Neulasta (pegfilgrastim). Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. What is Neulasta? What are the most common side effects of Neulasta? Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria Escherichia coli. G-CSF is a substance produced by the body. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body's fight against infection. The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a non-aspirin pain reliever, such as acetaminophen. Who should not take Neulasta? What about pregnancy or breastfeeding? Do not take Neulasta if you have had: Neulasta has not been studied in pregnant women, and its effects on unborn babies are not known. If you take Neulasta while you are pregnant, it is possible that small amounts of it may get into your baby's blood. It is not known if Neulasta can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should tell your doctor before using Neulasta. If you become pregnant during Neulasta treatment, you are encouraged to enroll in Amgen's Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll. • A serious allergic reaction to Neulasta® (pegfilgrastim) or to Neupogen® (filgrastim). What important information do I need to know about receiving Neulasta? Occasionally pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor. Neulasta should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy. The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance. What should I tell my healthcare provider before taking Neulasta? How should Neulasta be stored? Neulasta should be stored in the refrigerator at 2° to 8°C (36° to 46°F), but not in the freezer. Neulasta should be protected from light, so you should keep it in its carton until you are ready to use it. Avoid shaking Neulasta. If Neulasta is accidentally frozen, allow it to thaw in the refrigerator before injecting. However, if it is frozen a second time, do not use. Neulasta can be left out at room temperature for up to 48 hours. Do not leave Neulasta in direct sunlight. For all questions about storage, contact your doctor, nurse, or pharmacist. If you have a sickle cell disorder, make sure that your doctor knows about it before you start using Neulasta. If you have a sickle cell crisis after getting Neulasta, tell your doctor right away. What are the ingredients in Neulasta? If you have any questions, talk to your doctor. Each syringe contains pegfilgrastim in a sterile, clear, colorless, preservative-free solution containing acetate, sorbitol, polysorbate 20, and sodium. What are possible serious side effects of Neulasta? • Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta. A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. 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. • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing. • Serious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of Neulasta, stop the injection. Call your doctor right away. Neulasta® (pegfilgrastim) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 5,582,823; 5,580,755, as well as other patents or patents pending. © 2012 Amgen Inc. All rights reserved. www.neulasta.com 1-800-77-AMGEN (1-800-772-6436) v 9.0 XXXXX-RX-VX