Welcome to the MYNEULASTA

Transcription

1 If you haven t already been prescribed Neulasta or the On-body Injector for Neulasta, talk to your doctor about whether it is right for you. Welcome to the MYNEULASTA ( ) 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. If the On-body Injector for Neulasta was placed on the back of your arm, a caregiver must be available to monitor the On-body Injector for Neulasta. Please see Important Safety Information on pages

2 About your cancer care Being told you have cancer can feel overwhelming you ll have lots of new information to understand, appointments to keep, and decisions to make. Your healthcare team is there to help support and guide you throughout your journey, and to help you get the treatment option that is right for you. Chemotherapy, or chemo, is one of those treatment options it is given to help stop or slow down the growth of cancer, which is caused when cells in your body grow out of control. 1,2 Decreased white blood cells Increased risk of infection Strong chemotherapy may weaken your immune system. 5 The strong chemotherapy your doctor prescribed may reduce the number of white blood cells in your body. 3 White blood cells are a key part of your immune system your body s natural defenses against infection. As your white blood cell count goes down, your risk of infection goes up. 4 Important Safety Information Do not take Neulasta if you have had a serious allergic reaction to Neulasta (pegfilgrastim) or NEUPOGEN (filgrastim). Please see additional Important Safety Information on pages

3 Why your doctor has prescribed Neulasta (pegfilgrastim) Neulasta is a prescription medication used to help reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infection-fighting white blood cells. 5 Neulasta is similar to a protein made by your body and is sometimes called a white blood cell booster because it causes your body to make more white blood cells. This helps increase your natural defenses against infection. 6,7 Increased white blood cells Neulasta increases white blood cell counts. 7 Neulasta is given once for each cycle of chemotherapy. Neulasta should only be administered on the day your healthcare provider has determined and should not be delivered until approximately 24 hours after receiving chemotherapy. Important Safety Information Tell your healthcare provider if you: Have sickle cell trait or sickle cell disease Have had severe skin reactions to acrylic adhesives Are allergic to latex Have problems with your kidneys Have any other medical problems Are pregnant or plan to become pregnant. It is not known if Neulasta may harm your unborn baby 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. Please see additional Important Safety Information on pages

4 Getting to know the Neulasta (pegfilgrastim) Onpro kit The Neulasta Onpro TM kit includes the On-body Injector for Neulasta, which your healthcare provider activates by filling it with your Neulasta dose. Your Healthcare provider then applies the On-body Injector to your skin, either on the back of the arm or abdomen. It is applied on the same day you have chemotherapy, and you leave the doctor s office wearing the On-body Injector. The On-body Injector has been designed to deliver your Neulasta approximately 27 hours after your healthcare provider has applied it on your skin. Important Information While the On-body Injector for Neulasta is in place you should avoid: Traveling, driving or operating heavy machinery during hour 26 through hour 29 after the On-body Injector for Neulasta is applied. Sleeping on the On-body Injector for Neulasta or applying pressure on the On-body Injector for Neulasta. The On-body Injector for Neulasta may not work properly. Bumping the On-body Injector for Neulasta or knocking it off your body. Getting body lotion, creams, oils, and skin cleansing products near the On-body Injector for Neulasta. These products may loosen the adhesive that holds the On-body Injector for Neulasta onto your body. Using hot tubs, whirlpools, or saunas, and direct sunlight. These may affect Neulasta. Peeling off or disturbing the On-body Injector for Neulasta adhesive before you receive your full dose of Neulasta. Please see pages 8-9 for additional important information about the On-body Injector. 4

5 Understanding the On-body Injector for Neulasta (pegfilgrastim) 8,9 For full information about the On-body Injector, please see Patient Instructions for Use. Flashing green On-body Injector is working properly Solid green (or turned off) Medication delivery should be complete. Check to see if fill indicator reads empty and there is no noticeably wet adhesive Flashing red On-body Injector error call your healthcare provider immediately Status light Adhesive pad Audio On-body Injector will beep before and after dose delivery. Cannula window Allows you to view the cannula (a short, soft tube) that your Neulasta passes through during the 45-minute dose delivery. Actual size. Fill indicator The black line should be at FULL until the On-body Injector starts delivering your dose of Neulasta. The black line should be at EMPTY when your Neulasta delivery is complete. Please see Important Safety Information for Neulasta on pages

6 At the doctor s office: The day that the On-body Injector for Neulasta (pegfilgrastim) is applied 8,9 On the day of your chemotherapy, your healthcare provider will prepare an area of skin and apply the On-body Injector. Abdomen Back of upper arm What happens immediately after the On-body Injector is applied? Once the On-body Injector is placed on your skin, it will beep and the yellow light will flash. A short needle will insert the cannula, which is designed to allow Neulasta to be delivered under your skin 27 hours later. The needle is designed to go back into the On-body Injector, but the cannula will remain in place until the On-body Injector is removed. For the next 27 hours, the green light will flash every 5 seconds. This means the On-body Injector is working properly. Important Information Keep the On-body Injector for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. If the On-body Injector for Neulasta is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of Neulasta. Please see pages 8-9 for additional important information about the On-body Injector. Please see Important Safety Information for Neulasta on pages

7 At home or other setting: The day of Neulasta (pegfilgrastim) delivery 8 On the day of Neulasta delivery, you will be responsible for the following (as described in detail in the Patient Instructions for Use): It is important that you thoroughly review the Patient Instructions For Use. These instructions cover everything you need to know about the On-body Injector. The information in this brochure does not replace the Patient Instructions For Use. Please contact your healthcare provider if you have any questions. Check the status light occasionally. It should be flashing green for about 27 hours. If you hear beeping, check the status light. If the light is flashing RED, call your healthcare provider immediately. FULL EMPTY Monitor the dose delivery. Remember: A caregiver should be with you the first time that you receive Neulasta with the On-body Injector for Neulasta If the On-body Injector for Neulasta was placed on the back of your arm, always have a caregiver available to monitor the On-body Injector for Neulasta Remove the On-body Injector. FULL EMPTY Confirm the dose delivery. Dispose of the On-body Injector according to local laws and regulations to avoid accidental needle stick. To participate in Amgen s voluntary disposal program, call MYNEULASTA ( ) or click here to enroll. 7

8 What is the most important information I need to know about receiving Neulasta (pegfilgrastim) with the On-body Injector for Neulasta? 7 See the Instructions for Use for the On-body Injector for Neulasta for detailed information about the On-body Injector for Neulasta and important information about your dose delivery that has been written by your healthcare provider. Know the time that delivery of your dose of Neulasta is expected to start. Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the On-body Injector for Neulasta is applied. Avoid activities and places that may interfere with monitoring during the 45-minute period that Neulasta is expected to be delivered by the On-body Injector for Neulasta, and for 1 hour after delivery. A caregiver should be with you the first time that you receive Neulasta with the On-body Injector for Neulasta. 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 for Neulasta. Get emergency medical help right away. 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. The On-body Injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the On-body Injector for Neulasta on your skin. Continued on page 9. 8

9 What is the most important information I need to know about receiving Neulasta (pegfilgrastim) with the On-body Injector for Neulasta? 7 continued Do not expose the On-body Injector for Neulasta to the following because the On-body Injector for Neulasta may be damaged and you could be injured: MRI CT scan X-ray Ultrasound Oxygen-rich environments, such as hyperbaric chambers Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the On-body Injector for Neulasta from being accidentally removed. Keep the On-body Injector for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. If the On-body Injector for Neulasta is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of Neulasta. The On-body Injector is for adult patients only. Call your healthcare provider right away if the: On-body Injector for Neulasta comes off before or during a dose delivery. Do not re-apply it. On-body Injector for Neulasta is leaking. Adhesive on your On-body Injector for Neulasta becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that Neulasta is leaking out of your On-body Injector for Neulasta. If this happens you may only receive some of your dose of Neulasta, or you may not receive a dose at all. On-body Injector for Neulasta status light is flashing red. Please review the Patient Instructions for Use for complete instructions and information about the On-body Injector. Discuss any questions you have with your healthcare provider. The information in this guide is intended as a summary. It is not intended to replace any instructions from your healthcare provider or the Instructions For Use which came packaged with the On-body Injector for Neulasta. If you haven t already been prescribed Neulasta or the On-body Injector for Neulasta, talk to your doctor about whether it is right for you. 9 Please see Important Safety Information on pages

10 Important Safety Information7 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 health care provider before taking Neulasta? Tell your healthcare provider if you: Have sickle cell trait or sickle cell disease Have had severe skin reactions to acrylic adhesives Are allergic to latex Have problems with your kidneys Have any other medical problems Are pregnant or plan to become pregnant. It is not known if Neulasta may harm your unborn baby 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? 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. 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. Continued on page

11 Important Safety Information 7 continued 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. 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. 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. Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta. 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: swelling or puffiness and are urinating less often trouble breathing swelling of your stomach-area (abdomen) and feeling of fullness dizziness or feeling faint 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 negative side effects FDA at FDA For more information about Neulasta, talk with your healthcare provider or pharmacist; go to or call (1-844-MYNEULASTA). For more information, please see the full Prescribing Information for Neulasta. References: 1. Chemotherapy: What it is, how it helps. American Cancer Society. / pdf.pdf. Accessed June 4, What is cancer? American Cancer Society. Accessed June 4, Wujcik D. Infection. In: Yarbro CH, Frogge MH, Goodman M, eds. Cancer Symptom Management. Sudbury, MA: Jones and Bartlett Publishers, Inc; 2004: Caring for the patient with cancer at home: A guide for patients and families. American Cancer Society. Accessed June 4, Neulasta (pegfilgrastim) Important Safety Information. Thousand Oaks, CA: Amgen. 6. Neulasta (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen. 7. Neulasta (pegfilgrastim) Patient Prescribing Information. Thousand Oaks, CA: Amgen. 8. On-Body Injector for Neulasta (pegfilgrastim) Patient Instructions For Use. Thousand Oaks, CA: Amgen. 9. Neulasta (pegfilgrastim) Delivery Kit Healthcare Provider Instructions For Use. Thousand Oaks, CA: Amgen

12 Please see the completed Instructions for Use with your Dose Delivery Information. The Neulasta Onpro TM kit includes a single dose of Neulasta and a single-use On-body Injector Applied the same day as chemotherapy is administered 6 Designed to automatically administer Neulasta the next day (approximately 27 hours after application) 9 Visit to learn more about the Neulasta Onpro TM kit or call MYNEULASTA ( ). Do not take Neulasta if you have had an allergic reaction to Neulasta (pegfilgrastim) or to NEUPOGEN (filgrastim). Please see Important Safety Information on pages Please see the Neulasta full Prescribing Information, including the On-body Injector for Neulasta Patient Instructions For Use Amgen Inc. All rights reserved. USA