DEDICATED SUPPORT TO HELP YOU GET STARTED AND STAY ON TRACK THROUGHOUT YOUR TREATMENT

Transcription

1 LET US HELP YOU FIND A CLEARER PATH FORWARD. DEDICATED SUPPORT TO HELP YOU GET STARTED AND STAY ON TRACK THROUGHOUT YOUR TREATMENT PERSONALIZED SUPPORT FREE MEDICATION* $0 CO-PAY* WELCOME KIT RECYCLABLE SHARPS CONTAINER SUPPORT FOR YOUR FIRST YEAR * For commercially insured patients. Limitations apply. See details inside. INDICATIONS COSENTYX (secukinumab) is a prescription medicine used to treat adults: with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light, alone or with systemic therapy) with active psoriatic arthritis with active ankylosing spondylitis IMPORTANT SAFETY INFORMATION Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Consumer Brief Summary for a complete list of ingredients. Please see additional Important Safety Information throughout this brochure. Please see Consumer Brief Summary on pages

2 WE CAN HELP YOU GET GOING When you make the decision to start a different treatment, there s a lot to figure out. But you don t have to handle it all on your own. Your dedicated team at the COSENTYX Connect Personal Support Program is there to support you, answer your questions, and provide you with resources to help you get started and stay on track with your treatment. You can call COSENTYX, 24/7. There s always a pharmacist on call, and during normal business hours you can also speak to a health specialist or a financial specialist. This brochure contains photos of actual patients who have been compensated for their time. 2 Please see Important Safety Information throughout this brochure. 3

3 FREE MEDICATION* You may have access to free medication through the Covered Until You re Covered Program if you are commercially insured and you are experiencing a delay in getting access to COSENTYX, or your insurance plan does not cover COSENTYX. With the completion of a signed COSENTYX Service Request Form (SRF), the Covered Until You re Covered Program can support you with free medication while you wait.* If you re eligible, you could get up to 2 years of free medication. Call COSENTYX for more information. *Covered Until You re Covered Program: Eligible patients must have commercial insurance, a completed Service Request Form for COSENTYX, and be experiencing a delay in obtaining coverage. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for two years or until they receive insurance coverage approval. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension subject to approval by Novartis Pharmaceuticals Corporation. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, Tricare, or any other federal or state program. No purchase necessary. Participation is not a guarantee of insurance coverage. Once coverage is approved, patients will no longer be eligible. Limitations may apply. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice. Enrollment expires 12/31/17. If you have trouble with your insurance, they ll supply you with free medication while that gets worked out. Steven, taking COSENTYX since 2015 ONE-ON-ONE SUPPORT, ANY TIME YOU NEED IT IMPORTANT SAFETY INFORMATION COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Once you re enrolled in COSENTYX Connect, you ll be contacted by Infections a support specialist to help you get started and point you in the right COSENTYX may lower the ability of your immune system to fight infections direction. and may increase your risk of infections. Your doctor should check you for tuberculosis (TB) before starting As you get going, someone from our team will check in every so often to treatment with COSENTYX. see how you re doing. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Please see additional Important Safety Information throughout this brochure. Your doctor should watch you closely for signs and symptoms of TB 4 during treatment with COSENTYX. Do not take COSENTYX if you 5 have an active TB infection.

4 $ 0 CO-PAY $0 CO-PAY SAVINGS* You may be eligible for our $0 co-pay savings if your commercial insurance plan covers COSENTYX. The team of specialists at COSENTYX Connect will help coordinate this benefit. Enrolling is as simple as calling COSENTYX. * Limitations apply. For those commercially insured and 18 years or older. Up to a $16,000 annual cap. You will be responsible for any co-pay once limit is reached in a calendar year. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients. Novartis reserves the right to rescind, revoke, or amend this program without notice. Expires 12/31/16. IMPORTANT SAFETY INFORMATION Before starting COSENTYX, tell your doctor if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills warm, red, or painful skin muscle aches or sores on your body cough diarrhea or stomach pain shortness of breath burning when you urinate or blood in your phlegm urinate more often than normal weight loss After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. Inflammatory Bowel Disease New cases of inflammatory bowel disease or flare-ups can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Serious Allergic Reactions Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of Please see additional Important Safety Information throughout this brochure. your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or 6 throat tightness; chest tightness; or skin rash. If you have a severe 7 allergic reaction, do not give another injection of COSENTYX.

5 PLUS ONGOING RESOURCES, TOOLS, AND PERSONALIZED SUPPORT Once you get going, it s important to stay on track with your treatment plan. To help, you ll get additional services, benefits, and guidance from your dedicated team throughout your first year of treatment. Here s more of what you can expect as part of the COSENTYX Connect Personal Support Program. They know who you are when you call. They remember. It makes it more personal, because you re going to have a relationship with these people. Sonya, taking COSENTYX since 2015 WELCOME KIT WITH RESOURCES TO HELP YOU STAY ON TRACK This kit will be mailed to your home, and includes: Injection demonstration videos so you can see step-by-step instructions for taking your medication An insulated travel kit for taking your medication with you and keeping it at the right temperature A magnetic timer to help you keep track of the time it takes to get your medication to room temperature An injection reminder card and stickers to help you keep track of your injection schedule RECYCLABLE SHARPS CONTAINER PROGRAM To help you easily dispose of your injection materials, you ll be mailed a recyclable sharps container as part of our ongoing free sharps mail-back program. Just send back your full sharps container using the prepaid return label, and you ll be sent a new container. The process has been simple for me. They even send you a container for the needles. You drop em in there and once it s filled up, it comes in a prepaid box. You bring it to the post office. They mail it off, and you re all set. Gary, taking COSENTYX since 2015 ADDITIONAL RESOURCES MAILED TO YOUR HOME You ll get tools and information tailored to you sent to your home, so that you can keep track of your results and share them with your doctor. CONTINUED ONE-ON-ONE SUPPORT We ll reach out with a quick call or from time to time to see how you re doing, especially at specific milestones during your first year of treatment. We ll also share updates and tips to keep you inspired and informed. And don t forget, we re here 24/7 if you have questions. Please see additional Important Safety Important Information Safety Information throughout throughout this brochure. this brochure. 8 9

6 IMPORTANT SAFETY INFORMATION Before starting COSENTYX, tell your doctor if you: have any of the conditions or symptoms listed on page 7 for infections have inflammatory bowel disease (Crohn s disease or ulcerative colitis) are allergic to latex. The needle caps contain latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. have any other medical conditions are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. How should I use COSENTYX? See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes. Use COSENTYX exactly as prescribed by your doctor. If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse. The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see additional Important Safety Information throughout this brochure

7 CONSUMER BRIEF SUMMARY The risk information provided here is not comprehensive. This information does not take the place of talking with your doctor about your medical condition or treatment. To learn more about COSENTYX, talk to your doctor or pharmacist. For more information and to obtain the FDA-approved product labeling, call or visit What is the most important information I should know about COSENTYX? COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections. COSENTYX 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 COSENTYX. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection. Before starting COSENTYX, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills warm, red, or painful skin muscle aches or sores on your body cough diarrhea or stomach pain shortness of breath burning when you urinate or blood in your phlegm urinate more often than normal weight loss 12 After starting COSENTYX, call your healthcare provider right away if you have any of the signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your healthcare provider. 13

8 CONSUMER BRIEF SUMMARY (cont) See What are the possible side effects of COSENTYX? for more information about side effects. What is COSENTYX? COSENTYX is a prescription medicine used to treat adults: with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy) with active psoriatic arthritis with active ankylosing spondylitis COSENTYX may improve your condition, but it may also lower the ability of your immune system to fight infections. It is not known if COSENTYX is safe and effective in children. Who should not use COSENTYX? Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the end of the Consumer Brief Summary for a complete list of ingredients in COSENTYX. What should I tell my healthcare provider before starting COSENTYX? Before starting COSENTYX, tell your healthcare provider if you: have any of the conditions or symptoms listed in the section What is the most important information I should know about COSENTYX? have inflammatory bowel disease (Crohn s disease or ulcerative colitis) are allergic to latex. The needle cap on the COSENTYX Sensoready pen and prefilled syringe contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. have any other medical conditions are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your healthcare provider should decide if you will use COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How should I use COSENTYX? See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes. Use COSENTYX exactly as prescribed by your healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your healthcare provider. COSENTYX comes in a Sensoready pen or prefilled syringe that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of COSENTYX is best for you to use at home. Your healthcare provider will prescribe the dose of COSENTYX that is right for you. If your prescribed dose of COSENTYX is 150 mg, you must give 1 injection of COSENTYX for each dose. If your prescribed dose of COSENTYX is 300 mg, you must give 2 injections for each dose

9 CONSUMER BRIEF SUMMARY (cont) COSENTYX is given as an injection under your skin (subcutaneous injection), in your upper legs (thighs) or stomach-area (abdomen) by you or a caregiver. A caregiver may also give you an injection of COSENTYX in your upper outer arm. Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Each injection should be given at a different site. Do not use the 2-inch area around your navel (belly button). If you inject more COSENTYX than prescribed, call your healthcare provider or go to the nearest emergency room right away. What are the possible side effects of COSENTYX? See What is the most important information I should know about COSENTYX? Inflammatory bowel disease. New cases of inflammatory bowel disease or flare-ups can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn s disease), tell your healthcare provider if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Serious allergic reactions. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash The most common side effects of COSENTYX include: cold symptoms diarrhea upper respiratory infections These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA Keep COSENTYX and all medicines out of the reach of children. General information about the safe and effective use of COSENTYX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COSENTYX for a condition for which it was not prescribed. Do not give COSENTYX to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about COSENTYX that is written for health professionals. What are the ingredients in COSENTYX? Active ingredient: secukinumab Inactive ingredients: Sensoready pen and prefilled syringe: L-histidine/ histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection. Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose. If you have a severe allergic reaction, do not give another injection of COSENTYX

10 NOTES 18 Please see Important Safety Information throughout this brochure. 19

11 GET HELP GETTING STARTED AND THROUGHOUT YOUR TREATMENT JOURNEY WITH COSENTYX CONNECT. TALK TO YOUR DOCTOR WHILE YOU RE HERE TO FIND OUT IF COSENTYX IS RIGHT FOR YOU. For more information, call COSENTYX or visit COSENTYX.com Follow us on Hear real stories from real people taking COSENTYX at YouTube.com/COSENTYX QR CODE FOR INTERNAL USE ONLY. Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis Printed in USA 7/16 COS