Important Safety Information LONSURF® (trifl uridine and tipiracil) may cause serious side effects, including: • Low blood counts. Low blood counts are common with LONSURF and can sometimes be severe and life-threatening. LONSURF can cause a decrease in your white blood cells, red blood cells, and platelets. Low white blood cells can make you more likely to get serious infections that could lead to death. Your healthcare provider should do blood tests before you receive LONSURF, at day 15 during treatment with LONSURF, and as needed to check your blood cell counts. Your healthcare provider may lower your dose of LONSURF or stop LONSURF if you have low white blood cell or platelet counts Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with LONSURF: fever, chills, or body aches. Before taking LONSURF, tell your healthcare provider about all of your medical conditions, including if you: • Have kidney problems • Are pregnant or plan to become pregnant. LONSURF can harm your unborn baby – Females who can become pregnant should use effective birth control during treatment with LONSURF. Tell your healthcare provider immediately if you become pregnant – Males , while on treatment and for 3 months after your last dose of LONSURF, you should use a condom during sex with female partners who are able to become pregnant. Tell your healthcare provider right away if your partner becomes pregnant while you are taking LONSURF • Are breast-feeding or plan to breast-feed. It is not known if LONSURF passes into your breast milk. Do not breast-feed during treatment with LONSURF and for 1 day after your last dose of LONSURF Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. The most common side effects with LONSURF include tiredness, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever. Tell your doctor if you have nausea, vomiting, or diarrhea that is severe or that does not go away. These are not all of the possible side effects of LONSURF. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects. Please see full Prescribing Information in pocket. Important Safety Information 11 Please see Important Safety Information on page 11 and full Prescribing Information in pocket. in Information Prescribing full and 11 page on Information Safety Important see Please be severe and life-threatening. and severe be Low blood counts. blood Low LONSURF can decrease the number of your blood cells. This can sometimes can This cells. blood your of number the decrease can LONSURF LON-PM-US-0119 reserved. rights All 12/2015 INC. ONCOLOGY, TAIHO © Selected Important Safety Information Safety Important Selected patients who received placebo. received who patients the disease or death occurred in 88% of patients treated with LONSURF and 94% of of 94% and LONSURF with treated patients of 88% in occurred death or disease the and half of the patients who received placebo were still alive at 5.3 months. Worsening of of Worsening months. 5.3 at alive still were placebo received who patients the of half and In a clinical trial, half of the patients treated with LONSURF were still alive at 7.1 months months 7.1 at alive still were LONSURF with treated patients the of half trial, clinical a In It is not known if LONSURF is safe and effective in children. in effective and safe is LONSURF if known not is It treated with or cannot receive certain chemotherapy medicines. chemotherapy certain receive cannot or with treated colon or rectal cancer that has spread to other parts of the body and who have been previously previously been have who and body the of parts other to spread has that cancer rectal or colon (trifl uridine and tipiracil) is a prescription medicine used to treat people with with people treat to used medicine prescription a is tipiracil) and uridine (trifl LONSURF ® Pursue more moments more Pursue and full Prescribing Information in pocket. in Information Prescribing full and Please see Important Safety Information on page 11 11 page on Information Safety Important see Please LONSURF.com/assistance ou can also learn more about our patient support program at program support patient our about more learn also can ou Y TaihoPatientSupport.com visit Or 1-844-TAIHO-4U Call (1-844-824-4648) 24 hours a day, 7 days a week a days 7 day, a hours 24 For on-call nurse phone support: support: phone nurse on-call For 8:00 8:00 ET 8:00 – PM AM Monday through Friday, Friday, through Monday For fi nancial assistance: assistance: nancial fi For Taiho Oncology Patient Support Patient Oncology Taiho Introduction Table of contents Introduction We understand that you’re going through a lot living with colon or 3 Introduction rectal cancer that has spread to other parts of the body despite previous treatment with certain chemotherapy medicines. Taiho Oncology is committed to partnering with your healthcare provider to help you: • With fi nancial challenges you are facing in getting your medicine Taiho Oncology Patient Support • Take your medicine exactly as instructed by your healthcare provider 4 Financial support Taiho Oncology Patient Support is your online and on-call resource center for any questions or needs related to fi nancial assistance, reimbursement, 5 Personalized nurse support and your LONSURF treatment. 6 How to enroll Taiho Oncology also offers tools and resources to help you with your treatment plan. This brochure includes information about: • The services provided by Taiho Oncology Patient Support Additional tools and resources • How to enroll in Taiho Oncology Patient Support • Tools and resources for patients prescribed LONSURF 7 LONSURF® (trifl uridine and tipiracil) Starter Kit • Advocacy and support organizations for additional support 8 Video series: Importance of taking your medicine as prescribed 9 Advocacy and support organizations 11 Important Safety Information Please see Important Safety Information on page 11 and full Prescribing Information in pocket. 2 3 Taiho Oncology Patient Support Personalized nurse support Taiho Oncology partners with your healthcare provider to help support Taiho Oncology Patient Support is tailored your individual needs while you are on treatment. You can call the to your needs: 24-hour hotline and get answers to your questions about LONSURF, such as: • User-friendly • Informative • What to expect on treatment • Flexible • Side effects Patient Support Patient • Your treatment schedule Oncology Taiho • Anything else to do with LONSURF Financial support The following services are just a phone call away: Your on-call Nurse Navigator You don’t have to do it alone when it comes to treatment with LONSURF. Insurance coverage and reimbursement support Once you enroll in the Taiho Oncology Patient Support program, you have We are here to help you: the option to team up with a Nurse Navigator. He or she will help you by providing support over the phone concerning your treatment plan, including: • Understand your insurance coverage for LONSURF® (trifl uridine and tipiracil) and your out-of-pocket responsibility • Education about your treatment • Determine prior authorization requirements from your insurance company • Prescription refi ll and medication reminders • Work with your insurance company, if coverage is denied • Tips that may help manage side effects Co-pay savings for commercially insured patients • And more If you are commercially insured, you may be eligible to receive a Co-pay Card for help with your out-of-pocket expenses for LONSURF.* Ask your healthcare Your healthcare provider may have other ways of managing some of the provider or pharmacy for the Taiho Oncology Patient Support Co-pay Card if side effects of LONSURF. This could include adjusting your treatment plan by you have commercial insurance. changing your dosage or stopping treatment. Alternate funding support for Medicare/Medicaid– or Tips provided by the Nurse Navigator may also be helpful to you in government-insured patients managing some of the side effects of LONSURF while under your healthcare If you are Medicare/Medicaid or government insured, we will refer you to nonprofi t organizations that may be able to provide you with co-pay assistance. provider’s care; however, these tips may not always work. Patient Assistance Program for those unable to afford LONSURF Advice provided by the Nurse Navigator is not meant to replace your We may be able to provide LONSURF to you free of charge if you have: healthcare provider’s advice. Always discuss any side effect with your • No prescription insurance coverage healthcare provider. • Insuffi cient prescription insurance coverage • Insuffi cient fi nancial resources For more information about the Taiho Oncology Patient Support Pharmacy coordination Program, call 1-844-TAIHO-4U (1-844-824-4648) or go to We will be in contact with your pharmacy and your doctor and will keep you up to date about your prescription status. TaihoPatientSupport.com. *Restrictions apply. Please see Important Safety Information on page 11 and full Prescribing Information in pocket. 4 5 3 simple ways to enroll in the Taiho Oncology Additional tools and resources Patient Support program LONSURF Starter Kit 1. Fill out a Patient Enrollment Form at your doctor’s offi ce with your You may have received this brochure in the LONSURF Starter Kit. If you doctor, nurse, or support staff. The offi ce can then fax the form to received it separately and do not have a LONSURF Starter Kit, your 1-844-287-2559. doctor’s offi ce may be able to provide one. You can also get the Starter Kit from your specialty pharmacy or online at TaihoPatientSupport.com. 2. Fill out a Patient Enrollment Form online with your doctor, nurse, or The LONSURF Starter Kit is meant to help you take your medicine support staff at TaihoPatientSupport.com.