STRUGGLING TO LOWER YOUR HIGH CHOLESTEROL?

Transcription

1 STRUGGLING TO LOWER YOUR HIGH CHOLESTEROL? When diet and the highest tolerated dose of a statin are not enough, adding PRALUENT could make it PLUNGE. Not an actual patient. Individual results may vary. What Is PRALUENT? PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol The effect of PRALUENT on heart problems such as heart attacks, stroke, or death is not known Safety and efficacy in children is unknown

2 TABLE OF CONTENTS Considering PRALUENT (alirocumab)? 4 How Can I Tell if PRALUENT Is Working? 14 How Is PRALUENT Different? 8 Lifestyle Tips 15 Is PRALUENT Right for Me? 9 Getting Started With PRALUENT Patient Services 17 Results on PRALUENT 10 Find Help With the Cost of PRALUENT 18 About PRALUENT 11 Frequently Asked Questions 20 How to Take PRALUENT 12 Important Safety Information

3 STARTING A NEW MEDICATION IS A BIG STEP, AND YOU MAY HAVE QUESTIONS If you re thinking about or getting ready to start any medication, there s a lot to consider. But knowing more about what it is and how it works can help you feel better about taking it. This brochure is designed to help inform you about PRALUENT (alirocumab) Injection and answer questions you may have. PAY $0 FOR THE FIRST 6 MONTHS OF PRALUENT (alirocumab)* Why should I consider PRALUENT? Diet, exercise, statins. You ve tried them all. And if your bad (LDL) cholesterol is still high even after making changes to your lifestyle and taking the highest tolerated dose of a statin you may have started to think that there s nothing more you can do. If your healthcare provider thinks that you re not at goal, the good news is that PRALUENT may be able to help. PRALUENT is not a statin, but when taken on top of the highest tolerated dose of a statin, it may provide additional, significant reductions to your bad cholesterol levels. Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT 4 *Eligible patients with commercial insurance not funded through a government healthcare program subject to program terms and restrictions. Please click here for full Prescribing Information available at 5

4 WHY SHOULD I BE CONCERNED ABOUT MY HIGH CHOLESTEROL? Did you know that as your bad (LDL) cholesterol levels rise, so does your risk of heart disease? LDL cholesterol is a waxy substance found in your blood. It can build up in the walls of your arteries and form plaque, which can narrow the blood vessels. The higher your bad cholesterol, the greater your risk for developing heart disease or having a heart attack. Even if you ve made changes to your lifestyle and tried the highest tolerated dose of a statin, if your bad cholesterol is still high you re at risk. What Is PRALUENT (alirocumab)? PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol Knowing your bad cholesterol number and goal is important Use the chart below to see where you stand, then talk to your doctor to find out what your treatment options may be. LDL Cholesterol Level Less than 70 mg/dl Less than 100 mg/dl Category Ideal for patients at very high risk, or with existing heart disease Ideal for patients at high risk, without heart disease mg/dl Near ideal/above ideal mg/dl Borderline high mg/dl High 190 mg/dl and above Very high 6 The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined Please click here for full Prescribing Information available at 7

5 I M TAKING STATINS NOW. WHAT MAKES PRALUENT DIFFERENT? PRALUENT (alirocumab) works differently from a statin. PRALUENT works to help the liver s ability to remove bad (LDL) cholesterol from the blood. It is a treatment that is taken with the highest tolerated dose of a statin, and should be part of a plan that includes a healthy diet. IS PRALUENT RIGHT FOR ME? If you have heart problems due to plaque build-up in the arteries or have heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of bad cholesterol) and need additional lowering of bad cholesterol, your healthcare provider may decide it s time for PRALUENT. Together, you can decide if PRALUENT is right for you. Here are a few things to consider: Have you made changes in your lifestyle to lower your bad cholesterol? Are you taking the highest tolerated dose of a statin? Does your healthcare provider want you to lower your bad cholesterol levels any further? Before starting PRALUENT, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed If your bad cholesterol is still high even after making changes to your lifestyle and taking the highest dose of a statin tolerated PRALUENT may be able to help. 8 Please click here for full Prescribing Information available at 9

6 HOW MUCH CAN PRALUENT LOWER MY BAD CHOLESTEROL? In clinical studies of patients with heart problems due to plaque in the arteries or with HeFH* who were not at their bad (LDL) cholesterol goal despite being on the highest tolerated dose of a statin, adding PRALUENT (alirocumab) reduced their bad cholesterol an additional 44%-58%, on average So if diet, exercise, and statins haven t been enough to get your bad cholesterol to where it needs to be, talk to your doctor about adding PRALUENT Most people saw results in as little as 4 weeks Potential to lower LDL cholesterol with PRALUENT (example) 126 mg/dl A patient with LDL cholesterol of 126 mg/dl could see a reduction to as low as 68 mg/dl after 24 weeks Not an actual patient. WHAT ARE THE POSSIBLE SIDE EFFECTS OF PRALUENT? PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of an allergic reaction, including a swollen face, or trouble breathing The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site; symptoms of the common cold; and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away These are not all of the possible side effects of PRALUENT. Ask your healthcare provider or pharmacist for more information Individual results will vary. *HeFH=heterozygous familial hypercholesterolemia, an inherited condition that causes high levels of bad cholesterol

7 HOW DO I TAKE PRALUENT? PRALUENT (alirocumab) is taken once every 2 weeks by self-injection. It comes as a single-dose, pre-filled pen, so no measuring is required. PRALUENT comes in 2 dosage strengths, 75 mg and 150 mg. Most patients will reach their bad cholesterol goal on 75 mg, the recommended starting dose. Your healthcare provider will decide which dose is right for you. Important things to keep in mind: See the detailed Instructions for Use that comes with PRALUENT for information about the right way to store and give injections at home Self-injection support and training are available through PRALUENT Patient Services Nurses are on call 7 days a week, 24 hours a day to provide self-injection support and training. Just call us at PRALUENT ( ) and press 1 Visit PRALUENT.com to watch a video that will show you how to self-inject using the single-use pen. WHAT IF I HAVE QUESTIONS ABOUT SELF-INJECTING PRALUENT? If you and your healthcare provider decide PRALUENT is right for you, he or she will talk to you about the self-injection process. Be sure to ask any questions you may have. PRALUENT is delivered with an easy-to-use, single, 1-mL pen every 2 weeks regardless of the dose It may take up to 20 seconds to inject PRALUENT The pens are not made with natural rubber latex 75 mg 150 mg Push-button injection Medication and dosage label Color-coded by dose Patients self-injected at home with confidence and convenience* 94% were confident in their ability to self-inject 90% found the injection convenient to use * Evaluated in a cross-sectional, non-interventional study involving 151 patients enrolled in the PRALUENT randomized clinical trial program (ODYSSEY). Using the I-TAQ data, a number of analyses were performed to confirm the appropriateness of the hypothesized scoring and evaluate the psychometric properties of the I-TAQ domain scores and total score. These analyses included evaluation of item response distributions, factor analysis, multi-trait analysis, inter-item correlations, convergent validity through examining correlations with an existing measure of acceptance and known groups/discriminative validity. PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of an allergic reaction, including a severe rash, redness, severe itching, a swollen face, or trouble breathing Large inspection window Turns yellow when injection is completed so you know full dose has been delivered Yellow safety cover 12 Keeps needle hidden throughout the entire injection 13

8 HOW CAN I TELL IF PRALUENT IS HAVING THE DESIRED EFFECT? A problem with high cholesterol is that you can t feel it. So how will you be able to tell if PRALUENT (alirocumab) is lowering your bad (LDL) cholesterol? After starting PRALUENT, talk to your healthcare provider about a follow-up blood test to see where your bad cholesterol level stands. Talk to your healthcare provider about your cholesterol levels. The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site; symptoms of the common cold; and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away LIFESTYLE TIPS TO HELP MANAGE CHOLESTEROL Talk to your doctor before starting a new exercise routine. You may already know that diet and exercise are the first steps in managing bad (LDL) cholesterol. And while trying to make lots of changes at once can feel overwhelming, small steps can make a difference. Here are some simple ideas to add to your cholesterol management plan: Fuel your body with foods that help lower bad cholesterol It s not just about cutting calories, but giving your body the right kinds of food. A variety of fruits and vegetables can not only help keep the pounds off it can help reduce bad cholesterol Move toward success Being overweight can increase bad cholesterol levels and cardiovascular risks. But the good news is that you can take steps literally to fight back. Losing weight by increasing your activities like walking can help Make a plan for success Write down realistic goals for yourself, like taking a walk after dinner or eating more heart-healthy foods. Then, set a daily reminder on your phone to help you stick to it 14 Please click here for full Prescribing Information available at 15

9 WE RE WITH YOU EVERY STEP OF THE WAY PRALUENT Patient Services provides tailored support to help you start and stay on track with PRALUENT (alirocumab). Once you are enrolled, you will have access to: Live nurse support 7 days a week to answer questions about PRALUENT LET S GET STARTED No matter how you get PRALUENT, you can sign up for PRALUENT Patient Services at no cost on PRALUENT.com or by calling PRALUENT ( ). Educational s with lifestyle tips to manage bad cholesterol Injection reminders & helpful tips through text messages PRALUENT reminder magnet PRALUENT travel kit & sharps disposal container Care specialists can help determine if you are eligible for programs to help with the cost of PRALUENT. Still have questions? Visit PRALUENT.com or call us to get connected to the right kind of help. Talk to your healthcare provider about the right way to prepare and give yourself a PRALUENT injection and follow the Instructions for Use that comes with PRALUENT 16 17

10 SEE IF YOU QUALIFY FOR THE MYPRALUENT TM COPAY CARD The MyPRALUENT Copay Card Program helps eligible commercially insured patients with their out-of-pocket copay costs for PRALUENT (alirocumab)* For the first 6 months, patients may qualify to pay a $0 Copay, then pay up to $10 Copay a month after that for each refill. Restrictions apply PAY $0 FOR THE FIRST 6 MONTHS OF PRALUENT (alirocumab)* BIN# PCN# CN GRP# EC ID# Copay Card For information on how to sign up or activate a Copay Card, visit PRALUENT.com. You can also look up a lost Copay Card ID. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA-1088 You may qualify if you: Have private (commercial) insurance Are 18 or older Have a valid prescription for PRALUENT for an approved indication Live in the US or Puerto Rico ASSISTANCE NO MATTER YOUR HEALTH COVERAGE STATUS If you re not eligible for the MyPRALUENT Copay Card, we may still be able to help. Call us at PRALUENT ( ) to speak with a care specialist who can connect you with other programs that may help cover cost. PRALUENT is covered by the majority of health insurance and Medicare plans.* Government Insurance We can help you identify and find potential assistance from charitable organizations and foundations Patient Assistance Program You may qualify if you don t have insurance or you lack pharmacy benefit coverage Our team will research other sources of coverage to help with the cost of PRALUENT *Formulary data are provided by Managed Markets Insight & Technology, LLC (MMIT) and are current as of September Because formularies do change and many health plans offer more than one formulary, please check directly with the health plan to confirm coverage. Additional program conditions apply. 18 *Eligible patients with commercial insurance not funded through a government healthcare program subject to program terms and restrictions. 19

11 FREQUENTLY ASKED QUESTIONS What is PRALUENT (alirocumab)? PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol The effect of PRALUENT on heart problems such as heart attacks, stroke, or death is not known It is not known if PRALUENT is safe and effective in children Do I still need to take my cholesterol pills? Speak to your doctor if you have any questions, and take your medicine as directed What are the most common side effects of PRALUENT? The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site; symptoms of the common cold; and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away How much does PRALUENT cost? The cost of PRALUENT varies based on the type of insurance you have. But no matter your health care coverage, we are committed to finding the right program to help cover the cost of PRALUENT: If you have private (commercial) insurance, you may qualify to pay no more than $0 for the first 6 months of PRALUENT with the MyPRALUENT Copay Card. Then, you ll pay $10 a month or less, subject to an annual cap* If you have government insurance, we can help you identify and find potential assistance from charitable organizations and foundations Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. Before starting PRALUENT, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies. PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of an allergic reaction, including a severe rash, redness, severe itching, a swollen face, or trouble breathing. The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site; symptoms of the common cold; and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Talk to your healthcare provider about the right way to prepare and give yourself a PRALUENT injection and follow the Instructions for Use that comes with PRALUENT. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA If you don t have insurance or lack pharmacy benefit coverage, the Patient Assistance Program provides PRALUENT free of charge to eligible patients for up to 12 months. Eligible patients may submit for renewal For more information, call us at PRALUENT ( ) and press 1 *Eligible patients subject to restrictions. 21

12 NOTES: NOTES: My LDL Cholesterol Record Date LDL Level My LDL Cholesterol Record Date LDL Level 22 23

13 Talk to your doctor today about adding PRALUENT (alirocumab) and sign-up to receive additional information on PRALUENT.com 2016 Sanofi US and Regeneron Pharmaceuticals, Inc. All Rights Reserved. US.ALI US-PRB /2016