Life shouldn't take a back seat to plaque psoriasis. Journey toward clearer skin with SILIQ. Ask your healthcare provider if SILIQ is an option for you. What is SILIQ? SILIQ injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis: who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and who have tried another systemic therapy that didn t work or stopped working It is not known if SILIQ is safe and effective in children. What is the most important information I should know about SILIQ? Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening depression, anxiety, or mood problems; thoughts of suicide, dying, or hurting yourself; attempt to commit suicide, or acting on dangerous impulses; other unusual changes in your behavior or mood. Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers. Please see additional Important Safety Information on pages 8-10. including Boxed Warning about suicidal ideation and behavior and Medication Guide, or visit SILIQ.com.
What s driving your psoriasis? For many, SILIQ is a path to rapid, lasting results Psoriasis may seem like it s only skin deep, but it s triggered below the surface by an overactive immune system. This causes inflammation and too many skin cells to be produced. When you can t shed old skin cells fast enough, red, flaky patches known as plaques form. 3 2 1 Plaques Inflammation occurs, causing too many skin cells to multiply Overactive immune system produces proteins, called cytokines, that cause inflammation If you ve been living with moderate to severe plaque psoriasis, SILIQ may help you achieve and maintain completely clear skin. SILIQ works differently than other psoriasis medicines, tapping the brakes on your psoriasis by blocking a specific group of proteins at the site of inflammation. SILIQ reduced the redness, thickness, and scaling of psoriasis plaques for many of the more than 4400 people who used it in clinical studies. 8 out of 10 patients had: 75% clear skin at 12 weeks 4 out of 10 patients had: 100% clear skin at 12 weeks vs. 2 out of 10 Stelara patients 7 out of 10 patients with 100% clear skin at 12 weeks: remained clear at 1 year Plaques can cause symptoms such as: Stinging Flaking Redness Burning Itching Pain Cracking Scaling If you haven t achieved the level of clearance you re looking for, ask your healthcare provider if SILIQ may be a good option for you. Most Important Information (cont'd) Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/ painful skin sores, burning while urinating or more frequent urination Patients taking SILIQ saw: improvements as early as Week 1 Long-lasting, complete results are great, but getting those results faster is even better. So, even if you ve been around the block with other treatments without success, don t give up. Ask your healthcare provider if another medicine, such as SILIQ, may work for you. Selected Safety Information Do not use SILIQ if you have Crohn s disease. Please see page 9 for symptoms of Crohn s disease. The most common side effects of SILIQ include: joint pain, headache, tiredness, diarrhea, mouth or throat pain, nausea, muscle pain, injection site reactions, flu, low white blood cell count (neutropenia), fungal infections of the skin. Please see additional Important Safety Information on pages 8-10. behavior and Medication Guide, or visit SILIQ.com. 2 3
See real results with SILIQ Treating moderate to severe plaque psoriasis with SILIQ has shown dramatic results. These are real, unretouched photos of patients treated with SILIQ during a clinical trial. Individual results may vary. PATIENT B This patient had moderate psoriasis at baseline. After 12 weeks of treatment with SILIQ, this patient was graded as almost clear and remained almost clear after 1 year. PATIENT A This patient had a baseline PASI score of 40.6. After 12 weeks of treatment with SILIQ, his psoriasis had improved by 89% and he was completely clear (100% response) after 1 year. Baseline Baseline Week 12 Week 52 Week 12 Week 52 PATIENT C This patient had a baseline PASI score of 29.6. After 12 weeks of treatment with SILIQ, this patient saw 81% clearance and 96% clearance after 1 year of treatment. Selected Safety Information Before starting SILIQ, tell your healthcare provider if you: have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems have an infection that does not go away or keeps coming back have TB or have been in close contact with someone with TB have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Baseline Week 12 Week 52 Please see additional Important Safety Information on pages 8-10. behavior and Medication Guide, or visit SILIQ.com. 4 5
How to take SILIQ Support for your journey Here are some quick directions to help get you on the road to clearer skin. SILIQ is given as an injection under the skin (known as subcutaneous or SC injection). SILIQ starts with 1 injection each week for the first 3 doses. After that, it s just 1 dose every 2 weeks. Treatment Start 0 1 Ongoing Treatment Schedule 2 3 4 5 6 7 8... Your healthcare provider will help you in the process of getting SILIQ if it s right for you. They may be working with a specialty pharmacy to get it approved for you, or they can use the services provided by our Siliq Solutions program. Siliq Solutions includes a support team that can answer your questions about everything from injecting SILIQ to insurance and cost-saving opportunities. Call Siliq Solutions or your healthcare provider if you have any questions at all about SILIQ, including injection support: 1-855-RX-SILIQ (1-855-797-4547). Once weekly Every 2 weeks thereafter If your healthcare provider decides that you or a caregiver can give the injections at home, you will need to be trained by your healthcare provider on the right way to inject SILIQ. 1. Read the information in the Medication Guide and Instructions for Use found in the pocket at the back of this brochure. 2. View the instructional video about injections at SILIQ.com. 3. Your healthcare provider will show you how to prepare, inject, and dispose of SILIQ. Do not try to inject SILIQ before this training. Once you have completed these steps, you ll be ready to hit the road. Your healthcare provider may stop SILIQ if your plaque psoriasis does not improve within 12 to 16 weeks of treatment. Selected Safety Information SILIQ REMS Program: Because of suicidal thoughts and behavior seen in some SILIQ patients in clinical studies, SILIQ is only available through a restricted program called a REMS (Risk Evaluation and Mitigation Strategy). Patients must enroll in the program before starting SILIQ. Your healthcare provider will give you a SILIQ patient/ wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers. SILIQ Instant Savings Through the Siliq Solutions Instant Savings Program, if eligible, you may pay only $5 per month with commercial insurance coverage for SILIQ. If your commercial insurance does not cover SILIQ, or coverage is delayed or denied, you may pay $25 per month for SILIQ until coverage is approved or up to 12 months from program initiation. * To learn more about cost-saving opportunities, visit SILIQ.com. * Eligibility Criteria, Terms and Conditions for the Siliq Solutions Instant Savings Program: These offers are valid for commercially insured patients being treated with SILIQ (brodalumab) injection, for subcutaneous use, for an approved indication, and are good for use only with a SILIQ prescription at the time the prescription is filled. If a commercially insured patient s insurance covers SILIQ, he or she may pay $5 per month for SILIQ, up to a maximum savings limit of $20,000 for 12 months from the patient's first eligible date of program participation. Patient is responsible for all additional costs and expenses after savings program limit is reached. If a commercially insured patient s insurance does not cover SILIQ, or if coverage is delayed or denied, the patient may pay $25 per month for SILIQ, until coverage is approved or up to 12 months from program initiation. Uninsured patients are not eligible to participate in the Instant Savings Program. These offers are not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state or other governmental programs, including but not limited to Medicare (including Medicare Advantage and Part A, B and D Plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. Visit www.siliq.com/siliq-solutions for full Eligibility Criteria, Terms and Conditions. Please see additional Important Safety Information on pages 8-10. behavior and Medication Guide, or visit SILIQ.com. 6 7
Indication and Important Safety Information Indication What is SILIQ? SILIQ injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis: who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and who have tried another systemic therapy that didn t work or stopped working It is not known if SILIQ is safe and effective in children. Important Safety Information What is the most important information I should know about SILIQ? Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening depression, anxiety, or mood problems thoughts of suicide, dying, or hurting yourself attempt to commit suicide, or acting on dangerous impulses other unusual changes in your behavior or mood Your healthcare provider will give you a SILIQ patient/ wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers. Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/ painful skin sores, burning while urinating or more frequent urination Who should not use SILIQ? Do not use SILIQ if you have Crohn s disease. Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness, as these may be symptoms of Crohn s disease. Before starting SILIQ, tell your healthcare provider if you: have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems have an infection that does not go away or keeps coming back have TB or have been in close contact with someone with TB have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use SILIQ? See the detailed Instructions for Use that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes. Use SILIQ exactly as your healthcare provider tells you to use it. 8 9
Important Safety Information (cont d) Keep your healthcare provider up to speed What are possible side effects of SILIQ? SILIQ may cause serious side effects. See What is the most important information I should know about SILIQ? and Who should not take SILIQ? The most common side effects of SILIQ include: Joint pain Headache Tiredness Diarrhea Mouth or throat pain Nausea Muscle pain Injection site reactions Flu Low white blood cell count (neutropenia) Fungal infections of the skin Your healthcare provider can help you create personalized goals for your treatment. Considering these questions before your next visit can help start a conversation about your psoriasis. 1 How is my plaque psoriasis affecting me? Call your doctor for medical advice on side effects. You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. behavior, and Medication Guide, or visit SILIQ.com. 2 How important is it for me to be completely clear of psoriasis? 3 How do I feel about my previous or current treatment? 4 What would I like to achieve with treatment? /TM are trademarks of Ortho Dermatologics' affiliated entities. Third-party trademarks used herein are trademarks of their respective owners. 2017 Ortho Dermatologics SLQ.0210.USA.17 10 11
Resources for the road National Psoriasis Foundation Psoriasis.org The National Psoriasis Foundation (NPF) is a nonprofit organization that helps people manage their psoriasis. Visit the NPF website for the helpful tools and resources listed below. National Psoriasis Foundation Patient Navigation Center Psoriasis.org/navigationcenter Find out how NPF patient navigators can help guide you on your treatment journey. Whether preparing for a visit with your healthcare provider or connecting you with others who are living with psoriasis see how the Navigation Center can help. For more information about the Patient Navigation Center, send an email to education@psoriasis.org or call 1-800-723-9166. Talk Psoriasis Support Group Inspire.com/groups/talk-psoriasis A support and discussion group where you can connect with other psoriasis sufferers. Visit SILIQ.com for additional information and resources. Reference to third-party sites are provided as a convenience, and do not constitute or imply Ortho Dermatologics' endorsement or recommendation of such third party, its information, products or services. Ortho Dermatologics is not responsible for the information found on these sites. /TM are trademarks of Ortho Dermatologics' affiliated entities. Third-party trademarks used herein are trademarks of their respective owners. 2017 Ortho Dermatologics SLQ.0210.USA.17