by side Support Access Resources YOUR DEDICATED RESOURCE FOR ASSISTANCE with MYALEPT (metreleptin) for injection Introducing the BYMYSIDE Patient Support Program. Through the BYMYSIDE Program, you will work with a dedicated team made up of registered nurses, trained pharmacists, and a MYALEPT case manager. Call the toll-free BYMYSIDE support line at 1-855-669-2537, from 8 am to 8 pm (ET), Monday through Friday, to speak with a member of the BYMYSIDE team. THE BYMYSIDE PROGRAM CAN HELP YOU GET STARTED ON MYALEPT A BYMYSIDE team member is available to answer questions you may have about getting started on MYALEPT. From access and affordability support to preparation and administration training, we re here for you every step of the way. A BYMYSIDE team member can walk you through the benefits offered by the BYMYSIDE Program. ACCESS AND AFFORDABILITY OPTIONS SUPPORT FOR MYALEPT PREPARATION AND ADMINISTRATION SPECIALTY PHARMACY OFFERINGS
YOUR ACCESS AND AFFORDABILITY OPTIONS The BYMYSIDE Program aims to make MYALEPT (metreleptin) for injection accessible and affordable for patients. A BYMYSIDE case manager will work with you to navigate assistance programs and access options. Help for patients who have insurance If you have insurance, a BYMYSIDE team member can help you better understand your benefits. Help for patients who cannot afford their out-of-pocket costs, and patients who don t have insurance If you have insurance but cannot afford the out-of-pocket costs for MYALEPT, or if you are a patient without insurance, a BYMYSIDE team member can research alternative forms of funding and reimbursement, and explain all of your options. There is a savings program available to help eligible patients cover a portion of your out-of-pocket costs for MYALEPT You may also be eligible to receive assistance from other sources such as independent charitable foundations LEARN MORE Visit myaleptbymyside.com or call 1-855-669-2537, from 8 am to 8 pm (ET), Monday through Friday, to speak with a member of the BYMYSIDE team. 2
YOUR PREPARATION AND ADMINISTRATION SUPPORT Your healthcare provider will show you how to inject MYALEPT before you use it for the first time. A healthcare provider should also watch you inject your MYALEPT dose the first time you inject it. Do not inject MYALEPT until your healthcare provider has shown you the right way to inject it. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist. To help with this, the BYMYSIDE Program offers an optional In-Home Nursing Injection Support Program at no cost to you. Through this program, in addition to the training your healthcare provider provides, a registered home health nurse can come to your home to help supervise the preparation and administration of your first dose of MYALEPT. Talk to your healthcare provider or a BYMYSIDE team member about any questions you may have regarding preparation, administration, and storage of MYALEPT. Registered home health nurse MYALEPT administration assistance and supervision Step-by-step training on MYALEPT reconstitution and administration BENEFITS OFFERED MYALEPT resources including the Prescribing Information, Medication Guide, and Instructions for Use Helpful tips for staying on treatment and maintaining a regular dosing schedule 3
SUPPORT THROUGH A SPECIALTY PHARMACY MYALEPT (metreleptin) for injection is not available from retail pharmacies; it is dispensed only by a specialty pharmacy. This means that you cannot pick up your MYALEPT prescription from your local retail pharmacy it will be shipped directly to you or to your healthcare provider s office. At Aegerion, the BYMYSIDE team works with a specialty pharmacy to provide you with a full range of support. Specialty pharmacy offerings: Medication and supplies shipments Refill assistance, reminder calls, and check-ins Assistance with medication replacement 24/7 pharmacist and nurse support Ensure you receive your MYALEPT and supplies Please see the steps on the following page to learn how the BYMYSIDE team completes and fulfills your MYALEPT prescription. LEARN MORE Visit myaleptbymyside.com or call 1-855-669-2537, from 8 am to 8 pm (ET), Monday through Friday, to speak with a member of the BYMYSIDE team. 4
HOW THE BYMYSIDE TEAM FILLS YOUR PRESCRIPTION STEP 1 Your healthcare provider writes you a prescription for MYALEPT and faxes it to the BYMYSIDE Patient Support Program. STEP 2 A member of the BYMYSIDE team will contact you from a phone number you might not recognize to complete and fulfill your prescription for MYALEPT. STEP 3 A member of the BYMYSIDE team will work with you to Navigate your access and affordability options Eligible patients may receive reimbursement assistance; talk with a member of the BYMYSIDE team for eligibility requirements Coordinate your medication and supplies shipments from the specialty pharmacy STEP 4 The specialty pharmacy will ship your medication and supplies directly to you or to your healthcare provider s office. 5
APPROVED USE MYALEPT (metreleptin) for injection is a prescription medicine used with a healthcare provider-recommended diet to treat problems of leptin deficiency (lack of leptin) in people with congenital or acquired generalized lipodystrophy. It is not known if MYALEPT is safe and effective to treat problems caused by partial lipodystrophy or to treat liver disease, including non-alcoholic steatohepatitis (NASH). MYALEPT should not be used to treat people with HIV-related lipodystrophy or people with metabolic disease, including diabetes and high triglycerides, without signs or symptoms of congenital or acquired generalized lipodystrophy. IMPORTANT SAFETY INFORMATION MYALEPT may cause serious side effects, including: risk for loss of natural leptin activity or loss of MYALEPT efficacy due to neutralizing antibodies. Some people who use MYALEPT make antibodies in their blood that may reduce how well the leptin in their body (endogenous) works or how well MYALEPT works. Side effects may include infection, problems with blood sugar (including diabetes), or an increase in the amount of fat in your blood (triglycerides) increased risk of lymphoma (a type of blood cancer) MYALEPT is only available through a restricted program called the MYALEPT Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the MYALEPT REMS Program go to www.myaleptrems.com or call 1-855-669-2537. Do not use MYALEPT if you have general obesity not caused by a congenital leptin deficiency or are allergic to metreleptin or any of the ingredients in MYALEPT. Before using MYALEPT, tell your healthcare provider if you have any medical conditions including if you: have or have had problems with your blood cells, including low blood cell counts (especially your white blood cells), bone marrow, immune system, pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or use insulin or a sulfonylurea are pregnant or plan to become pregnant as it is unknown if MYALEPT will harm your unborn baby. If you become pregnant while using MYALEPT, talk to your healthcare provider about registering with a program to collect information about the outcomes of moms and babies exposed to MYALEPT during pregnancy. You can enroll in the MYALEPT program by calling 1-855-669-2537 are nursing or plan to nurse. You should not nurse while you take MYALEPT 6
Tell your healthcare provider about all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements. Take MYALEPT exactly as your healthcare provider instructs you. For newborns and infants, mix MYALEPT with sterile water for injection (preservative-free) (WFI). MYALEPT contains benzyl alcohol when mixed with a liquid called bacteriostatic water for injection (BWFI). Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol. Low blood sugar (hypoglycemia) can occur when MYALEPT is used with medicines that can cause hypoglycemia, such as insulin or sulfonylurea. Your insulin or sulfonylurea dose may need to be lowered while you use MYALEPT. Signs and symptoms of low blood sugar may include shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, and/or feeling jittery. Talk to your doctor about the symptoms and treatment for hypoglycemia. Worsening symptoms of autoimmune disease may occur in people who have or have had certain problems with their immune system. Talk to your doctor about what symptoms you should watch for that may require further testing. Allergic reactions (hypersensitivity), including serious allergic reactions, can happen in people who use MYALEPT. Call your healthcare provider right away if you have any signs or symptoms of an allergic reaction including swelling of the face, lips, tongue or throat; problems breathing or swallowing; rash; itching (hives); fainting or feeling dizzy; or very rapid heartbeat. The most common side effects of MYALEPT include headache, low blood sugar (hypoglycemia), decreased weight, and/or abdominal pain. Talk to your healthcare provider about any side effect that bothers you or that does not go away. 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. 7
by side Support Access Patient Support Program Resources YOUR DEDICATED RESOURCE FOR ASSISTANCE with MYALEPT (metreleptin) for injection The BYMYSIDE team is here to help. A member of the BYMYSIDE team will Work with you to navigate MYALEPT access and affordability options In addition to the training provided by your doctor, provide you with support for MYALEPT preparation and administration Coordinate your MYALEPT shipment with the specialty pharmacy LEARN MORE Visit myaleptbymyside.com or call 1-855-669-2537, from 8 am to 8 pm (ET), Monday through Friday, to speak with a member of the BYMYSIDE team. 2015 Aegerion Pharmaceuticals, Inc. MYALEPT is a registered trademark and BYMYSIDE is a trademark of Aegerion Pharmaceuticals, Inc. All rights reserved. MYA/US/053 9/15.