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Important information for patients starting ZYTIGA®. Beginning Your Treatment. Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. Answers Start Here. Your doctor has prescribed ZYTIGA® (abiraterone acetate) as your next treatment option. You probably have a lot of questions, and this booklet is a great place to start finding the answers. What’s Inside: What Is mCRPC? 3 What Is The Role Of Androgen? 3 What Is ZYTIGA®? 3 How Does ZYTIGA® Work? 3 What Should I Know About ZYTIGA®? How Do I Take ZYTIGA®? 6–13 14 Where Can I Find Information And Resources? 16–17 What Are My Cost Support Options? 18–19 How Do I Get My ZYTIGA®? More Support For Your Journey Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 20 21–22 2 What Is mCRPC? Metastatic castration-resistant prostate cancer (mCRPC) is a form of advanced prostate cancer that is resistant to medical (e.g., hormonal) or surgical treatments that lower testosterone, and has spread to other parts of the body. In other words, your prostate cancer has progressed on androgen deprivation* therapy (ADT) and has spread to other parts of the body. What Is The Role Of Androgen? Androgens like testosterone are male hormones the body produces naturally, but when you have metastatic castration-resistant prostate cancer (mCRPC), androgens can help fuel the tumor. What Is ZYTIGA® (abiraterone acetate)? ZYTIGA® (zy-tee-ga) is an oral, once-daily medication used in combination with prednisone to treat metastatic castration-resistant prostate cancer, a type of advanced prostate cancer that is resistant to medical (eg, hormonal) or surgical treatments that lower testosterone, and has spread to other parts of the body. How Does ZYTIGA® Work? ZYTIGA® works by interrupting the androgen-making process at an important step. It inhibits androgen production at three sources—the testes, the adrenal glands, AND the tumor itself. *Androgen deprivation – A treatment to suppress or block the production or action of male hormones. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute, 2013. Available at www.cancer.gov/dictionary. Accessed 4/29/2016.) 3 ZYTIGA® may cause serious side effects including: High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema). Tell your healthcare provider if you get any of the following symptoms: •Dizziness • Fast heartbeats • Feel faint or lightheaded •Headache •Confusion • Muscle weakness • Pain in your legs • Swelling in your legs or feet Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress. Liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes: • • • Yellowing of the skin or eyes Darkening of the urine Severe nausea or vomiting Continued On Next Page Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 4 Continued From Prior Page Before you take ZYTIGA® (abiraterone acetate), tell your healthcare provider if you: Have heart problems Have liver problems Have a history of adrenal problems Have a history of pituitary problems Have any other medical conditions Plan to become pregnant (See “Who should not take ZYTIGA®?”) Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk. You and your healthcare provider should decide if you will take ZYTIGA® or breastfeed. You should not do both. (See “Who should not take ZYTIGA®?”) Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines. 5 What Should I Know About ZYTIGA®? ZYTIGA® plus prednisone is a treatment option for men with mCRPC (prostate cancer that is resistant to medical or surgical treatments that lower testosterone, and has spread to other parts of the body). ZYTIGA® is the first oral, once-daily medication for mCRPC. Since its approval in 2011, more than 80,000 men in the U.S. have been prescribed ZYTIGA®.* * Estimate based on sales and use data from April 2011 to December 2015. Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 6 Clinical Study Results. In a clinical study of 1,088 men with mCRPC whose disease had progressed while on androgen deprivation therapy (ADT) and had not received prior chemotherapy: Certain men who received ZYTIGA® (abiraterone acetate) plus prednisone lived longer than men who received placebo* plus prednisone. The median overall survival1 was 34.7 months for the group of men who received ZYTIGA® plus prednisone compared to 30.3 months for the group of men who received placebo plus prednisone. Please speak to your doctor about what this may mean to you. MEDIAN OVERALL SURVIVAL 34.7 30.3 Men who had received ZYTIGA® plus prednisone Men who had received placebo plus prednisone MONTHS MONTHS *Placebo – An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute, 2013. Available at www.cancer.gov/dictionary. Accessed 4/29/2016.) MEDIAN TIMEisTO STARTING The median overall survival the length of time fromCHEMOTHERAPY assigned study group to the time when half of the patients in the group diagnosed with the disease are still alive in a clinical trial. (National Cancer Institute: of Cancer Terms. Bethesda, MD: National Cancer Institute, 2013. Available at Men NCI whoDictionary had MONTHS www.cancer.gov/dictionary. Accessed 4/29/2016.) received ZYTIGA® plus prednisone 1 25.2 16.8 7 Continued On Next Page Men who had received placebo plus prednisone MONTHS Continued From Prior Page In the same study, at a planned analysis, fewer men with mCRPC had disease progression as measured by imaging studies in the group who received ZYTIGA® plus prednisone, compared to the group who received placebo plus prednisone. 28% (150 of 546) of men who received ZYTIGA® plus prednisone had progression, as measured by imaging studies. 46% (251 of 542) of men who received placebo plus prednisone had progression, as measured by imaging studies. Please speak to your doctor about what this may mean to you. The Most Common Side Effects Of ZYTIGA® (abiraterone acetate) Include: •Weakness •Joint swelling or pain •Swelling in your legs or feet •Hot flushes •Diarrhea •Vomiting •Cough •High blood pressure •Shortness of breath •Urinary tract infection •Bruising • Low red blood cells (anemia) and low blood potassium levels • High blood sugar levels, high blood cholesterol and triglycerides • Certain other abnormal blood tests Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Continued On Next Page Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 8 34.7 MONTHS 30.3 MONTHS Clinical Study Results Continued Men who had received ZYTIGA® plus prednisone Men who had received placebo plus prednisone ZYTIGA® (abiraterone acetate) plus prednisone delayed the beginning of chemotherapy compared to placebo plus prednisone in certain men with mCRPC. MEDIAN TIME TO STARTING CHEMOTHERAPY Men who had received ZYTIGA® plus prednisone Men who had received placebo plus prednisone 25.2 16.8 MONTHS MONTHS Clinical Study Results Summarized. As you have seen, in a clinical study at a planned analysis, certain men with mCRPC who received ZYTIGA® plus prednisone lived longer and the median time their disease did not progress as measured by imaging studies was longer, compared to those who received placebo plus prednisone. ZYTIGA® plus prednisone also delayed the start of chemotherapy in certain men with mCRPC as compared to placebo plus prednisone. Talk to your doctor to see if ZYTIGA® is right for you. 9 What Are The Potential Side Effects Of ZYTIGA® (abiraterone acetate)? IMPORTANT SAFETY INFORMATION Who should not take ZYTIGA®? Do not take ZYTIGA® if you are pregnant or may become pregnant. ZYTIGA® may harm your unborn baby. Women who are pregnant or who may become pregnant should not touch ZYTIGA® without protection, such as gloves. ZYTIGA® is not for use in women or children. Keep ZYTIGA® and all medicines out of the reach of children. Before you take ZYTIGA®, tell your healthcare provider if you: Have heart problems Have liver problems Have a history of adrenal problems Have a history of pituitary problems Have any other medical conditions Plan to become pregnant (See “Who should not take ZYTIGA®?”) Continued On Next Page Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 10 Continued From Prior Page Before you take ZYTIGA® (abiraterone acetate), tell your healthcare provider if you: Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk. You and your healthcare provider should decide if you will take ZYTIGA® or breastfeed. You should not do both. (See “Who should not take ZYTIGA®?”) Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines. If you are taking ZYTIGA®: Take ZYTIGA® and prednisone exactly as your healthcare provider tells you. Take your prescribed dose of ZYTIGA® one time a day. Your healthcare provider may change your dose if needed. Do not stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first. Take ZYTIGA® on an empty stomach. Do not take ZYTIGA® with food. Taking ZYTIGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects. No food should be eaten 2 hours before and 1 hour after taking ZYTIGA®. Swallow ZYTIGA® tablets whole. Do not crush or chew tablets. Take ZYTIGA® tablets with water. Your healthcare provider will do blood tests to check for side effects. Continued On Next Page 11 Continued From Prior Page Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with ZYTIGA®. If their female partner may become pregnant, a condom and another form of birth control must be used during and for one week after treatment with ZYTIGA®. Talk with your healthcare provider if you have any questions about birth control. If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away. ZYTIGA® may cause serious side effects including: High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema). Tell your healthcare provider if you get any of the following symptoms: •Dizziness • Fast heartbeats • Feel faint or lightheaded •Headache •Confusion • Muscle weakness • Pain in your legs • Swelling in your legs or feet Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress. Liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes: • • • Yellowing of the skin or eyes Darkening of the urine Severe nausea or vomiting Continued On Next Page Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 12 Continued From Prior Page The Most Common Side Effects Of ZYTIGA® (abiraterone acetate) Include: •Weakness •Joint swelling or pain • Swelling in your legs or feet •Hot flushes •Diarrhea •Vomiting •Cough •High blood pressure •Shortness of breath •Urinary tract infection •Bruising • Low red blood cells (anemia) and low blood potassium levels • High blood sugar levels, high blood cholesterol and triglycerides • Certain other abnormal blood tests 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 ZYTIGA®. FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA®. Call your doctor for medical advice about side effects. 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 (1-800-332-1088). 051527-160418 Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine. 13 How Do I Take ZYTIGA® (abiraterone acetate)? Take ZYTIGA® and prednisone exactly as your healthcare provider tells you. ZYTIGA® is a once-daily, oral medication you can take at home. The recommended dose of ZYTIGA® is 1,000 mg (four 250-mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily. Your healthcare provider can change your dose if needed. Take ZYTIGA® on an empty stomach. Do not take ZYTIGA® with food. Taking ZYTIGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects. No food should be eaten 2 hours before and 1 hour after taking ZYTIGA®. Swallow ZYTIGA® tablets whole. Do not crush or chew tablets. Take ZYTIGA® tablets with water. Do not stop taking your prescribed dose of ZYTIGA® or prednisone without talking with your healthcare provider first. Tablets shown are not actual size. Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 14 What Else Should I Keep In Mind When Taking ZYTIGA® (abiraterone acetate)? The recommended dose of ZYTIGA® is 1,000 mg (four 250-mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily. Take your prescribed dose of ZYTIGA® one time a day. Your healthcare provider may change your dose if needed. Your healthcare provider will do blood tests to check for side effects. While taking ZYTIGA® you will also take prednisone. Because of the way ZYTIGA® works, certain side effects may occur. Prednisone may help decrease the occurrence and severity of these side effects. For more information, talk to your doctor. Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with ZYTIGA®. If their female partner may become pregnant, a condom and another form of birth control must be used during and for one week after treatment with ZYTIGA®. Talk with your healthcare provider if you have questions about birth control. If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away. 15 Where Can I Find Information And Resources? ZytigaOne® Support, your ZytigaOne® Support Case Coordinator and a host of other useful resources are available to provide support that may help you throughout your journey with ZYTIGA®. Working With ZytigaOne® Support. You or your doctor can choose to use ZytigaOne® Support as a convenient resource for services and information. ZytigaOne® Support may investigate your insurance benefits to understand your coverage for ZYTIGA® by request from your prescriber, or you may call ZytigaOne® Support to start this process yourself. If your prescriber requested this for you, a ZytigaOne® Support Case Coordinator will be contacting you shortly to explain your benefits. 1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 16 Real People, Personalized Support. The ZytigaOne® Support Case Coordinators are the heart of ZytigaOne® Support. Your personally assigned ZytigaOne® Support Case Coordinator can: Assess your insurance coverage and call you to explain your insurance benefits and potential medication out-of-pocket expenses. Provide information on cost support options, such as an instant savings program or referral to a patient assistance program, as appropriate for eligible patients. Provide additional support, such as a weekly cost support status call, monthly prescription reminders, and educational materials delivered to your email or front door. Coordinate with a specialty pharmacy to arrange for efficient handling and shipment of your ZYTIGA® (abiraterone acetate). 17 What Are My Cost Support Options? A ZytigaOne® Support Case Coordinator can speak to you about several options for helping you manage your out-of-pocket costs for treatment, whether you have commercial insurance, government insurance such as Medicare, or are uninsured. If you choose to receive this service, a ZytigaOne® Support Case Coordinator can call you on a regular basis to check on the status of your support and can even keep your prescriber in the loop by sending them a status report. If You Have Commercial Insurance: The ZytigaOne® Instant Savings Program. This savings program is available to eligible patients with commercial insurance and may help with out-of-pocket costs. Your ZytigaOne® Support Case Coordinator will determine your eligibility and explain the benefits of enrollment. Eligible patients pay no more than $10 per month* for their ZYTIGA® prescription after activating their card. BIN: GROUP: MEMBER: SEE REVERSE • RESTRICTIONS APPLY *Per calendar year, subject to a $12,000 annual program benefit or a one-year supply, whichever comes first. Not valid for patients enrolled in Medicare Part D or Medicaid. Other restrictions may apply. Please read the accompanying Important Product Information for ZYTIGA® (abiraterone acetate) and discuss any questions you have with your doctor. ZytigaOne® Support is in no way an extension of medical treatment provided by healthcare professionals for individual patients. The program goal is to provide additional information and customer service for patients receiving treatment with ZYTIGA®. The ZytigaOne® Support program may be discontinued at any time. You may discontinue your participation at any time by calling 1-855-ZYTIGA-1 (998-4421). Please see Important Product Information and talk to your doctor if you have any questions. Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 18 If You Have Commercial Insurance, Medicare, Medicaid, or TRICARE: Independent Foundations Your ZytigaOne® Support Case Coordinator can direct you to alternate sources of funding through independent foundations. Call ZytigaOne® Support for more information, including help with understanding which foundations may be able to provide additional support. Foundation support may be available for ZYTIGA® (abiraterone acetate) from: CancerCare CancerCare.org Phone: 1-800-813-HOPE (1-800-813-4673) E-mail: [email protected] If You Are Uninsured: Patient Access Network Foundation Panfoundation.org Phone: 1-866-316-PANF (1-866-316-7263) E-mail: [email protected] Patient Advocate Foundation Copays.org Phone: 1-866-512-3861 Other Resources Your ZytigaOne® Support Case Coordinator can also provide you with a detailed list of other resources that may offer additional cost support, including a patient assistance program for those who are uninsured. For a comprehensive list of affordability options, visit JanssenPrescriptionAssistance.com/ZYTIGA. 19 How Do I Get My ZYTIGA® (abiraterone acetate)? Unlike other medications you can get at your neighborhood drugstore, ZYTIGA® is only available through a specialty pharmacy. These pharmacies carry certain medications and can deliver ZYTIGA® right to your home or any location you choose. If your prescriber sent your ZYTIGA® prescription to ZytigaOne® Support when requesting a benefit investigation, your ZytigaOne® Support Case Coordinator will work with your specialty pharmacy to ensure you get your prescription. Alternatively, your doctor may choose to send your prescription directly to the specialty pharmacy. If you have any questions about getting ZYTIGA®, you can always call your ZytigaOne® Support Case Coordinator. Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 20 More Support For Your Journey. Advocacy Connector Found at www.advocacyconnector.com, this tool provides web-based oncology resources organized by different types of cancer, including prostate. This makes it easy to find advocacy groups that provide resources based on your needs. My Prostate Cancer Roadmap® Visit www.myprostatecancerroadmap.com to find a wide range of information and resources for those who have, or care for someone with, advanced prostate cancer. This includes perspectives and insights from a variety of experts. Personalized Refill Reminders If you opt in, your ZytigaOne® Support Case Coordinator will call you 7 days before your ZYTIGA® (abiraterone acetate) prescription needs to be refilled to remind you to do so. The Medication Tracker For ZYTIGA® Available at ZYTIGA.com/begin, this printable, monthly calendar is designed so you can create a medication schedule that works best for you. 21 Care4Today™ Mobile Health Manager Manage your medications from your mobile phone or computer with Care4Today™ Mobile Health Manager. This free smartphone app and website from Janssen Research & Development, LLC lets you set up reminders for any kind of prescription, over-the-counter medication, or nutritional supplement. It uses two-way messaging so your progress reports can be shared with your healthcare provider or caretaker. Download the free app today at the App Store, Google Play™ or mhm.care4today.com. Tips For Staying On Therapy Sticking to a treatment schedule is important. These tips available at ZYTIGA.com/begin can help you remember to take ZYTIGA® exactly as your doctor has prescribed. Additional Educational Materials To opt in for more educational materials, visit ZYTIGA.com/begin or call your ZytigaOne® Support Case Coordinator. For more information on ZYTIGA® support tools and resources, visit ZYTIGA.com/begin or call 1-855-ZYTIGA-1 (1-855-998-4421). Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 22 Notes: 23 Notes: Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 24 Notes: 25 Please see the Important Safety Information on pages 10–13 and click here for accompanying Important Product Information. 26 To Learn More, Visit ZYTIGA.com/begin. Please see Important Product Information and talk to your doctor if you have any questions. Janssen Biotech, Inc. 800 Ridgeview Drive Horsham, PA 19044 USA © Janssen Biotech, Inc. 2016 05/16 035531-160304