Strong chemotherapy can put you at risk for serious infection. Why go back to the doctor st Joan Lunden talks th fellow survivors. thomewithjoan.com ights reserved. ter Drive 0-1799 Indication 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. Do not take Neulasta if you have had a serious allergic reaction to pegfilgrastim or filgrastim. Please read the additional on
Strong chemotherapy can put you at risk for serious infection. Why go back to the doctor Eligible commercially insured patients could pay $5 or less Per dose. Up to annual limit. See page 17 for more details. when you can stay home.* Before you receive Neulasta, tell your healthcare provider about all of your healthcare conditions, including if you: Have a sickle Important cell disorder; Safety have Information had severe skin reaction to acrylic adhesive; are allergic to latex the needle cap on the prefilled syringe contains dry Before natural you rubber receive (derived Neulasta from, tell latex); your have healthcare kidney provider problems; about are all pregnant of your medical or plan conditions, to become including pregnant. if It you: is not have known sickle if Neulasta cell disorder; may severe harm skin your reaction unborn to baby; acrylic are adhesive; breastfeeding are allergic or plan to to latex; breastfeed. have It kidney is not problems; known if Neulasta are pregnant passes or plan into to your become breast pregnant. milk. * If, If, for any reason, you believe you did not receive your full full dose of of Neulasta or or that your on-body-injector (OBI) is is not working correctly, immediately contact your healthcare provider as as an an incomplete dose could increase infection risk. Please read the additional on Neulasta Onpro. Designed to deliver Neulasta, which helps you fight the risk of infection at home or other appropriate setting.
Introduction Being diagnosed with cancer can be overwhelming. If your treatment plan includes strong chemotherapy, this guide can help. Strong chemotherapy (chemo) works by killing the fast-growing cancer cells in your body. At the same time, it can lower your white blood cell count increasing your risk of serious infection during treatment. On the following pages, you ll learn how Neulasta can help reduce the risk of infection, and how Neulasta Onpro is designed to help you fight infection risk from home. Already using Neulasta Onpro? Find practical information about using the product on pages 12-16. TABLE OF CONTENTS 4 Introduction 5 How Neulasta Works 7 Stay Home With Neulasta Onpro 9 How Neulasta Onpro Works 13 Overview For Using Neulasta Onpro 17 Financial Resources 19 Things To Know About Neulasta 21 Tell your healthcare provider if you 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 read the additional on 3 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 4
How Neulasta Works Given approximately 24 hours after your strong chemo treatment, Neulasta works like a natural protein to signal the growth of white blood cells, called neutrophils, which strengthen your immune system. Neulasta Reduced Infection Risk by 94% In a key study of 928 patients with breast cancer, when given once every chemotherapy cycle, Neulasta significantly reduced the risk of infection. 17% of patients got infections when not treated with Neulasta while only 1% of patients got infections when treated with Neulasta. 17% 94% reduction in occurences of neutropenia with fever 1% patients who got infections when not treated with Neulasta patients who got infections when treated with Neulasta Neulasta is the #1 prescribed white blood cell booster to help reduce the risk of infection during strong chemotherapy. Neulasta helps reduce the risk of infection. So your doctor may recommend it for your first cycle through your last. Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or left shoulder tip area. Please read the additional on 5 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 6
Stay Home With Neulasta Onpro * Less Burden, More Flexibility Once available only by manual injection, most patients had to return to the clinic the day after strong chemo to get their Neulasta shot. Neulasta Onpro can eliminate the burden of going back to the clinic. Plus, it gives you more flexibility in scheduling your strong chemo treatments. With Neulasta Onpro, you can get your Neulasta dose any day of the week including weekends and holidays. * In the event of a missed or partial dose, patients may need to return to the doctor s office for their dose of Neulasta as an incomplete dose could increase infection risk. The day after chemo, the last thing you want to do is return to the doctor. With Neulasta Onpro, you can spend the day after chemo at home or other appropriate setting. The innovative delivery system is designed to automatically deliver Neulasta the next day.* A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. Please read the additional on 7 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 8
How Neulasta Onpro Works Right after your strong chemo treatment, your healthcare provider will apply the on-body-injector (OBI) to your skin. The on-bodyinjector (OBI) is designed to automatically deliver your Neulasta dose over 45 minutes, approximately 27 hours after activation. Once your dose is complete, remove the Injector and dispose of it as instructed in the Patient Instructions for Use. Flashing green: On-body-injector (OBI) is working properly. Solid green (or turned off): Medication delivery should be complete. Check to see if the fill indicator reads empty and there is no noticeably wet adhesive. Flashing red: On-body-injector (OBI) error call your healthcare provider immediately. Audio Cannula Window The on-body-injector (OBI) will beep before and after dose delivery. Allows you to view the cannula (a short, soft tube) that your Neulasta passes through during the 45-minute dose delivery. Status Light Adhesive Pad The pad attaches the on-body-injector (OBI) directly to the skin on the back of your arm or abdomen. Fill Indicator The black line should be at FULL until the on-bodyinjector (OBI) starts delivering your dose of Neulasta. The black line should be at EMPTY when your Neulasta delivery is complete. The summary does not replace the Patient Instructions for Use. It s important that you review the Patient Instructions for Use that came with the on-body-injector (OBI) and contact your healthcare provider if you have any questions. Important Information While the on-body-injector (OBI) is in place you should avoid: Traveling, driving or operating heavy machinery during hour 26 through hour 29 after the on-body-injector (OBI) is applied. Sleeping on the on-body-injector (OBI) or applying pressure on the on-body-injector (OBI). The on-body-injector (OBI) may not work properly. Bumping the on-body-injector (OBI) or knocking it off your body. Please see pages 19-20 for additional important information. Please read the additional on 9 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 10
Did you know? Over 450,000 patients have used Neulasta Onpro since it was introduced in 2015 95% of patients would choose Neulasta Onpro again if they needed Neulasta * * Of the 77 oncology patients interviewed who had experience with Neulasta Onpro, 73 responded yes to the following question: Based on your personal experience, if your doctor said you needed to use Neulasta again in the future, would you request getting it with Neulasta Onpro again? Serious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate and sweating. Please read the additional on 11 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 12
Overview For Using Neulasta Onpro At the Doctor s Office On the same day of your chemo, your healthcare provider will prepare an area of your skin and apply the on-body-injector (OBI). Overview For Using Onpro Abdomen The information in this section will help you know what to expect when using Neulasta Onpro. Your doctor prescribed Neulasta to help protect against the risk of infection during your strong chemo treatment. Neulasta Onpro allows you to get Neulasta at home without having to return to the doctor s office the day after chemo. This information is a summary and does not replace the Patient Instructions for Use. It s important that you thoroughly review the Patient Instructions for Use. These instructions cover everything you need to know about the on-body-injector (OBI). If you have any questions, please contact your healthcare provider. Back of upper arm Once the on-body-injector (OBI) is placed on your skin, it will beep and a yellow light will flash. A short needle will insert the cannula, which is designed to deliver Neulasta under your skin. The needle is designed to go back into the onbody-injector (OBI), but the cannula will remain in place until the on-body-injector (OBI) is removed. Once the on-body-injector (OBI) is applied to your skin, you can go home. For the next 27 hours, the green light will flash every 5 seconds. This means the on-body-injector (OBI) is working properly. 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. Please read the additional on Sickle Cell Crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Please see pages 19-20 for additional important information. Please read the additional on 13 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 14
Overview For Using Neulasta Onpro FULL EMPTY At Home With Neulasta Onpro, you ll be able to stay home the day after chemo*. On the day of Neulasta delivery, you ll need to do a few things. 1. Check the status light occasionally to make sure it continues to flash green. 2. If you hear beeping, check the status light. If the light is flashing RED, call your healthcare provider immediately. 3. Know when Neulasta delivery is expected to start. Monitor dose delivery. Remember, a caregiver should be with you the first time you receive Neulasta with the on-bodyinjector (OBI). And if the on-body-injector (OBI) was placed on the back of your arm, always have a caregiver available to monitor it. 4. Remove the on-body-injector (OBI) and confirm dose delivery. 5. Dispose of the on-body-injector (OBI). The free Sharps Disposal Container Program helps you easily and safely dispose of the on-body-injector (OBI) for Neulasta. To enroll, complete the mailing card attached. Or call 1-844-MYNEULASTA or visit www.neulastaonpro.com to enroll. Name Address * If, for any reason, you believe you did not receive your full dose of Neulasta or that your on-body-injector (OBI) is not working correctly, immediately contact your healthcare provider. Incomplete doses have been reported with Neulasta Onpro due to device not performing as intended. This may increase the risk of neutropenia, febrile neutropenia and/or infection. City State Zip 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 (OBI). The information in this brochure does not replace the Patient Instructions For Use. Please contact your healthcare provider if you have any questions. Important Information Keep the on-body-injector (OBI) at least 4 inches away from electrical equipment such as cellphones, cordless telephones, microwaves and other common appliances. If the on-bodyinjector (OBI) 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 19-20 for additional important information. Please read the additional on Phone Moisten the adhesive on all three sides of the form, then fold down to seal it. Drop the completed form in a mailbox. You should receive your disposal container in about 7-10 business days. Questions? Call 1-844-MYNEULASTA, or visit www.neulastaonpro.com Order your FREE disposal container today Visit NeulastaOnpro.com/DisposalContainer or complete the information below and mail it. 15 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 16
Need Help Finding Financial Resources For Neulasta? 1 The Neulasta FIRST STEP Program 2 The Neulasta FIRST STEP program can help you reduce out-of-pocket costs for your Neulasta and Neulasta Onpro prescription if you purchase your own insurance plan or receive one through your job. No out-of-pocket cost for the first dose No income eligibility requirement For subsequent doses, Amgen will pay the out-of-pocket amount in excess of $5 per dose, up to $10,000 in assistance per calendar year. Whatever insurance you have even if you have none Amgen 360 TM can help you understand how your Amgen medicine may be covered and refer you to programs that may be able to help you afford it, such as Neulasta FIRST STEP or other independent nonprofit organizations b. For more information, contact us at 1-888-4ASSIST (1-888-427-7478). b Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits criteria. Amgen has no control over these programs and provides referrals as a courtesy only. Log on to www.neulastafirststep.com or call 1-888-657-8371 to find out more. Patient Eligibility Requirements : Patient must be prescribed Neulasta treatment Must have private commercial health insurance that covers medication costs for Neulasta Not a participant in any federal-, state-, or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TriCare Patients may not seek reimbursement for value received from the Amgen FIRST STEP Program from any third-party payers, including flexible spending accounts or healthcare savings accounts. If at any time patients begin receiving coverage under any federal-, state-, or government-funded healthcare program, patients will no longer be eligible to participate in the Amgen FIRST STEP Program and must call 1-888-65-STEP1 (1-888-657-8371) Monday through Friday, 9 AM-8 PM EST to stop participation. Restrictions may apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time. This is not health insurance. * Program invalid where otherwise prohibited by law. Register before any Amgen treatment. Coverage Limits: Program covers out-of-pocket medication costs for the Amgen product only. Program does not cover any other costs related to office visit or administration of the Amgen product. Other restrictions may apply. No out-of-pocket cost for first dose or cycle; $5 out-of-pocket cost for subsequent dose or cycle; for Neulasta (pegfilgrastim) and Neulasta Onpro, maximum benefit of $10,000 per patient per calendar year. Patient is responsible for costs above this amount. Ongoing activation of the Amgen FIRST STEP card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider s office within 45 days of use of the Amgen FIRST STEP card. Patients will be responsible for reimbursing the program for all amounts paid out if the EOB for the date of service is not received within 45 days. Subject to program eligibility requirements and coverage limits. Other restrictions apply. Not valid where prohibited by law. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time. 17 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 18
Things To Know About Neulasta Onpro Do not expose the on-body-injector (OBI) to the following because the on-body-injector (OBI) may be damaged and you could be injured: Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray) Radiation treatment 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-bodyinjector (OBI) from being accidentally removed. Keep the on-body-injector (OBI) at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. If the on-body-injector (OBI) 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 (OBI) is for adult patients only. See the Instructions for Use for the on-body-injector (OBI) for information about the on-body-injector (OBI). 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 (OBI) 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 (OBI), and for 1 hour after delivery. A caregiver should be with you the first time that you receive Neulasta with the on-body-injector (OBI). If your on-body-injector (OBI) is not working properly, you may miss your dose or you may not receive your full dose of Neulasta. If you miss your dose or do not receive your full dose of Neulasta, you may have an increased risk of developing fever or infection. Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur: On-body-injector (OBI) for Neulasta comes off before or during a dose delivery. Do not re-apply it. On-body-injector (OBI) for Neulasta is leaking. Adhesive on your on-body-injector (OBI) 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 (OBI) 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 (OBI) for Neulasta status light is flashing red. If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body-injector (OBI). If you have an allergic reaction during the delivery of Neulasta, remove the on-body-injector (OBI) by grabbing the edge of the adhesive pad and peeling off the on-body-injector (OBI). 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-bodyinjector (OBI) is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body-injector (OBI) on your skin. Please review the Patient Instructions for Use for instructions and information about the on-body-injector (OBI). 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 (OBI). Please read additional on 19 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 20
Do not take Neulasta if you have had a serious allergic reaction to pegfilgrastim or filgrastim. Before you receive Neulasta, tell your healthcare provider about all of your healthcare conditions, including if you: Have a sickle cell disorder Have had severe skin reaction to acrylic adhesive Are allergic to latex - The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). Have kidney 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 the 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 healthcare provider right away if you have pain in the left upper stomach area or left shoulder tip. A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. Serious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate and sweating. 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. Sickle Cell Crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Kidney injury (glomerulonephritis). Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: swelling of your face or ankles, blood in your urine or dark colored urine, or you urinate less than usual. Increased white blood cell count (leukocytosis). Your healthcare provider 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 than usual trouble breathing swelling of your stomach area (abdomen) and feeling of fullness dizziness or feeling faint a general feeling of tiredness Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. The most common side effect of Neulasta is pain in your bones and in your arms and legs. These are not all the possible side effects of Neulasta. Call your healthcare provider for medical advice about side effects. You may report negative side effects to the FDA at 1-800-FDA-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). Please click here for Neulasta Patient Information. 21 neulasta.com 1-844-MYNEULASTA (1-844-696-3852) 22
Veteran journalist Joan Lunden talks one-on-one with fellow survivors. Watch the series: AtHomeWithJoan.com 2018 Amgen Inc. All rights reserved. USA-003-80175 Amgen, One Amgen Center Drive Thousand Oaks, CA 91320-1799 www.amgen.com