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Erleada-Patient-Brochure.Pdf Table of Contents The path of prostate cancer. ......................................................... 3 How ERLEADA® (apalutamide) may help ........................................... 4 How androgens help fuel prostate cancer ......................................... 6 How to take ERLEADA®. .............................................................. 7 I’m hopeful. How to get ERLEADA® ................................................................ 8 I’m determined. Get help paying for your ERLEADA® ................................................. 9 I’m ready Important Safety Information ...................................................... 11 to fight my prostate cancer. Connecting with your healthcare team ........................................... 13 Questions to ask your doctor ....................................................... 13 What is ERLEADA®? ERLEADA® (apalutamide) is a prescription medicine used for the treatment of prostate cancer: • that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR • that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. It is not known if ERLEADA® is safe and effective in females. It is not known if ERLEADA® is safe and effective in children. IMPORTANT SAFETY INFORMATION Savings & Support Information • ERLEADA ® may cause serious side effects including: Heart disease, stroke, or mini-stroke, fractures and falls, and seizure 833-ERLEADA (833-375-3232) or • The most common side effects of ERLEADA® include feeling very tired, joint pain, JanssenCarePath.com/Erleada rash—tell your healthcare provider if you get a rash, decreased appetite, fall, weight loss, hypertension, hot flash, diarrhea, fracture Please see the Important Safety Information throughout and on pages 11-12, and click here for the Important Product Information. 1 1 ERLEADA® (apalutamide) is used to treat men with mCSPC and nmCRPC Prostate cancer that HAS SPREAD mCSPC to other parts of the body and STILL responds to a Metastatic: Prostate medical or surgical treatment that cancer has spread Cancer to other parts lowers testosterone. of the body This is called Castration-Sensitive: metastatic castration-sensitive still responds to a medical or surgical prostate cancer, or mCSPC. treatment that lowers testosterone Prostate cancer that HAS NOT SPREAD nmCRPC to other parts of the body and NO LONGER responds to a Non-metastatic: Prostate cancer has not Cancer medical or surgical treatment that spread to other lowers testosterone. parts of the body This is called Castration-Resistant: non-metastatic castration-resistant no longer responds to a Important Safety Information prostate cancer, or nmCRPC. medical or surgical treatment Before taking ERLEADA®, tell your healthcare provider about all that lowers testosterone your medical conditions, including if you: • have a history of heart disease • have high blood pressure • have diabetes • have abnormal amounts of fat or cholesterol in your blood (dyslipidemia) • have a history of seizures, brain injury, stroke, or brain tumors Please see the Important Safety Information throughout and on pages 11-12, and click here for the Important Product Information. 2 The path of prostate cancer Not all prostate cancer is the same. It ranges from cancer that has not spread beyond the prostate to cancer that has spread to other parts of the body (metastasis). The most common sites where prostate cancer can spread are bones, adrenal gland, liver, and lungs. Prostate cancer can include the following: mCSPC Some men may already have metastatic Metastatic castration- prostate cancer at their initial diagnosis sensitive prostate cancer Prostate cancer that: • Has spread to other parts of the body • Still responds to a medical or surgical treatment that lowers mCRPC testosterone Metastatic castration- LOCALIZED BIOCHEMICAL resistant prostate cancer PROSTATE CANCER RECURRENCE OR Prostate cancer that: PSA FAILURE • Has spread to other Prostate cancer that has parts of the body PSA* levels in the blood • o longer responds to not spread beyond a medical or surgical the prostate rise after surgery or radiation treatment that lowers nmCRPC testosterone Non-metastatic castration- resistant prostate cancer Some men respond to surgery or radiation *PSA: prostate-specific antigen Prostate cancer that: and do not need further treatment. • Has not spread to other For some men, the cancer may progress parts of the body • o longer responds to at some point. a medical or surgical treatment that lowers testosterone See the clinical study results with ERLEADA® (apalutamide) in men with mCSPC and nmCRPC on the following pages. Please see the Important Safety Information throughout and on pages 11-12, and click here for the Important Product Information. 3 In a clinical study, ERLEADA® (apalutamide) gave certain men a chance to live longer In men with prostate cancer that HAS SPREAD to ERLEADA® gave certain men more time without their other parts of the body and still responds to a medical or cancer progressing‡ surgical treatment that lowers testosterone % ® † In this clinical study, ERLEADA + ADT* was compared with placebo + ADT in a clinical 52 ® REDUCED ERLEADA + ADT reduced the risk study of 1052 men with metastatic castration-sensitive prostate RISK OF cancer (mCSPC). PROGRESSION‡ of prostate cancer progressing by 52% vs men taking placebo + ADT In this study, men either received ERLEADA® at a dose of 240 mg once daily or placebo. All patients in the study received ADT.* Median (middle) data has not been reached for ERLEADA®. In this clinical study, % The clinical study for men with mCSPC also evaluated this 33 additional measure: ERLEADA® + ADT reduced the REDUCED RISK OF DEATH risk of death by 33% vs men ERLEADA® gave certain men more time without taking placebo + ADT starting chemotherapy Median (middle) data has not been reached. In this clinical study, % ® 61 ERLEADA + ADT reduced the REDUCED RISK risk of beginning chemotherapy OF BEGINNING CHEMOTHERAPY vs men taking * Androgen deprivation therapy includes medical or surgical treatment that lowers testosterone. by 61% † Pronounced “pluh-see-bow”: a pill that looks like “real” medicine, but contains nothing to placebo + ADT affect health. ‡Progression was defined as the length of time patients lived without their disease spreading further as measured by imaging studies or dying. Median (middle) data has not been reached. Important Safety Information, (continued) Tell your healthcare provider about all the medicines you take, Please see the Important Safety Information throughout and on including prescription and over-the-counter medicines, vitamins, and herbal pages 11-12, and click here for the Important Product Information. supplements. ERLEADA® can interact with many other medicines. 4 ERLEADA® (apalutamide) helped delay the spread of prostate cancer Overall Survival PLACEBO + ADT 5. In men with prostate cancer that HAS NOT SPREAD Length of time MEDIAN MONTHS to other parts of the body and no longer responds to a patients lived after ERLEADA® + ADT 73. medical or surgical treatment that lowers testosterone starting treatment MEDIAN MONTHS as part of the study. ® † ERLEADA + ADT* was compared with placebo + ADT in a clinical A{ DDITIONAL study of 1207 men with non-metastatic castration-resistant 14 MONTHS VS PLACEBO + ADT prostate cancer (nmCRPC). In this study, patients either received ERLEADA® at a dose of 240 mg MEDIAN MONTHS once daily or placebo. All patients in the study received ADT.* Progression-Free Survival Length of time patients lived without 40.5 14.7 ® their prostate cancer spreading to local WITH VS WITH In this clinical study, ERLEADA + ADT delayed the spread of cancer or distant parts of the body or death. ERLEADA® PLACEBO to other parts of the body or death by 2 years (24.3 months) compared +ADT +ADT with placebo + ADT % MEDIAN‡ MONTHS: Median number of months living without metastasis. 37 Time to Chemotherapy REDUCED RISK OF BEGINNING Length of time from when patients began study CHEMOTHERAPY VS PLACEBO to starting chemotherapy. 16.2 MONTHS + ADT PLACEBO + ADT Median (middle) data has not been reached. 40.5 MONTHS *Androgen deprivation therapy includes medical or surgical treatment that lowers testosterone. ® ERLEADA + ADT †Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health. ‡Median means that for 50% of the patients, living without metastasis was longer than { 40.5 months, and for 50% of the patients, it was shorter than 40.5 months. 24.3 ADDITIONAL MONTHS VS PLACEBO + ADT Important Safety Information, (continued) You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA®. Please see the Important Safety Information throughout and on Know the medicines you take. Keep a list of them with you to show to your pages 11-12, and click here for the Important Product Information. healthcare provider and pharmacist when you get a new medicine. 5 ERLEADA® (apalutamide) + ADT work together to lower androgens that can help fuel the prostate cancer Androgens are male hormones, ERLEADA® blocks primarily testosterone, that androgens from attaching are needed for the prostate to to receptors to help function normally. prevent cancer cells from However, when androgens growing. attach to androgen receptors, they can help fuel prostate cancer cell growth. The goal of ADT is to lower androgen levels
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