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Description: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

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Skip to main content This website is for US audiences only Top Navigation Medication Guide Instructions for Use Important Safety Information For Healthcare Providers Prescribing Information REMS Toggle navigation Main navigation GL and Leptin How Myalept Works Taking Myalept GL Stories Resources and Support Learn About Myalept REMS Top Navigation Medication Guide Instructions for Use Important Safety Information For Healthcare Providers Prescribing Information REMS X This information is intended for US healthcare providers I am a US Healthcare Provider Return to Myalept.com X You are leaving the Myalept website. DISCLAIMER You have selected a link to a site written and published by persons not affiliated with Aegerion Pharmaceuticals, Inc., an Amryt Company. The views expressed in the site are those of the author(s) and do not reflect the views of Amryt. Additionally, the information contained in these articles may not be current. Amryt disavows any obligation to correct or to update the information contained in this site. You are leaving the Myalept website. Do you wish to continue? YES No, Stay on Myalept.com Discover Myalept Myalept® replaces leptin, an important hormone that people with generalized lipodystrophy (GL) are missing. It’s used with a doctor-recommended diet and treats problems caused by not having enough leptin in people with GL. It is not known if Myalept is safe and effective when used to treat problems (complications) 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 mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy. Why is leptin important? I would say Dena's main love is theatre. She really has the self-confidence to get up there and perform, even though she looks different and she is different. Shelly, Dena's mother Troy was losing body fat. This resulted in not having enough leptin. Jason, Troy’s father 2 ways leptin helps the body function Leptin is an important hormone that helps control certain metabolic processes. See what leptin does Myalept helps treat certain problems from not enough leptin in people with GL Myalept has been shown to lower triglyceride levels, lower blood sugar levels, and lower A1C levels. How Myalept can help People share their experiences with GL Read the stories of people with GL. Read real stories of GL We’re here to help Whether you want more information, have questions, or are looking for resources and support, we're by your side. Connect with ByMySide to learn more. To speak with a ByMySide Coordinator, call 1-855-6MYALEPT (1-855-669-2537), Monday through Friday, 8 am to 8 pm ET. ByMySide is a personalized support program for Myalept patients. When you complete the Patient Authorization Form for the ByMySide program you can access additional support services and resources at no cost to you. These are in addition to the support you are currently receiving in regard to your Myalept therapy through your dedicated nurse case manager including insurance investigation financial assistance (for eligible patients), 24/7 nurse support, nurse education and injection training, dietician support, and refill reminders. Download Patient Authorization Form Risk of Neutralizing antibodies and risk of lymphoma. Important Safety Information Myalept is only available through a restricted program called the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled and certified in the program in order to prescribe Myalept. Myalept may cause serious side effects, including: risk for developing certain proteins called neutralizing antibodies that may reduce how well your own leptin or Myalept works. Side effects of these antibodies may include infection, problems with blood sugar (including diabetes), or an increase in triglycerides increased risk of a type of blood cancer called lymphoma You should not take Myalept if you: have general obesity not caused by a congenital leptin deficiency are allergic to metreleptin or any of the ingredients in Myalept. Symptoms of an allergic reaction include rash, itching (hives), swelling of face, lips, tongue, or throat, problems breathing or swallowing, fainting or dizziness, rapid heartbeat. Before using Myalept, tell you doctor 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 Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other possible side effects The most common side effects of Myalept include headache, low blood sugar, decreased weight, and/or abdominal pain. For newborns and infants, mix Myalept with sterile water for injection (preservative-free) (WFI). Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol. Bacteriostatic water for injection contains benzyl alcohol and it should not be used to mix Myalept for newborns and infants. You may get low blood sugar (hypoglycemia) if you take Myalept with other medicines used to lower blood sugar, such as insulin or sulfonylurea. Your doses of these medications may need to be lowered while you use Myalept. Tell your doctor right away if you experience shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, or a jittery feeling because these may be signs of low blood sugar (hypoglycemia). Myalept may worsen symptoms caused by certain problems in your immune system (autoimmune disorder). Ask your doctor about what symptoms you should watch for that may require further testing. Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Myalept. For more information, speak to your doctor or pharmacist. Tell your doctor about all the medications you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Take Myalept exactly as your doctor instructs you. 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 . This is the most important information about Myalept. For more detailed information, Please see the Medication Guide and full Prescribing Information including Box Warning. What is Myalept? Myalept (metreleptin), a prescription medication, is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin (leptin deficiency) in people with generalized lipodystrophy. It is not known if Myalept is safe and effective when used to treat problems (complications) 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 mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy. Please see the Medication Guide and full Prescribing Information including Box Warning. ...

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