These Terms of Use and Website Privacy Statement (“Terms”) govern the use of the Amryt Pharma Plc and its subsidiaries (including Aegerion Pharmaceuticals Inc. (“Aegerion”) ) websites (the “Site”). ANYONE ACCESSING THE SITE AGREES TO ABIDE BY THESE TERMS. 

Amryt Pharma Plc and its subsidiaries (including Aegerion Pharmaceuticals Inc.), (together “Amryt”, “we” or “us”) may modify these Terms at any time, and such modification shall be effective immediately upon posting on the Site. Your continued access or use of the Site after the modifications have become effective shall be deemed your conclusive acceptance of the modified Terms.

  1. Licence. The contents of our Site, including its “look and feel” ( e.g., text, graphics, images, logos, and button icons), editorial content, notices, software (including HTML or XML-based computer programs) and other material, are protected under both United States and foreign copyright, trademark, and other laws. These contents belong or are licensed to Amryt or Aegerion. We hereby grant you the right to view and use the Site subject to these Terms. You may download or print a copy of information provided in the Site for internal use or distribution only. Permission to reprint or electronically reproduce any document or graphic in whole or in part for any other purpose is expressly prohibited, unless prior written consent is obtained from us. 
  2. Your Responsibility. You assume all responsibility for your use of, or access to, this Site, including your access to any Amryt or other literature obtained through the Site, and waive all claims or causes of action against Amryt or Aegerion or their respective the officers, directors, employees, agents and affiliates in connection therewith.
     
  3. Third-Party Resources On Our Site. This Site may contain links to websites operated by other parties. The linked sites are not under the control of Amryt or Aegerion, and we are not responsible for the content available on any other Internet sites linked to this Site. Such links do not imply our endorsement of material on any other site, and Amryt and Aegerion disclaims all liability with regard to your access to such linked websites. Amryt and Aegerion provide links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this Site is at your own risk.
     
  4. Disclaimer. THIS SITE AND THE INFORMATION IT CONTAINS IS MADE AVAILABLE “AS IS,” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. WE MAKE NO GUARANTEE THAT THE INFORMATION ON THIS SITE IS UP-TO-DATE, ACCURATE, OR COMPLETE, AND YOU SHOULD NOT RELY ON IT FOR ANY DECISION OR TO TAKE ANY ACTION. WE HEREBY DISCLAIM ANY WARRANTY THAT THE INFORMATION ON THIS SITE WILL BE FREE OF INTERRUPTION, OR THAT THE SITE IS FREE OF VIRUSES, WORMS, TROJAN HORSES OR OTHER CODE THAT MANIFEST CONTAMINATING OR DESTRUCTIVE PROPERTIES. Changes are periodically made to the information herein; these changes will be incorporated in new editions of the Site.
     
  5. Indemnity. You agree to indemnify, defend and hold harmless Amryt and Aegerion, and their respective officers, directors, employees, agents and affiliates from and against all losses, expenses, damages and costs, including reasonable attorneys’ fees, arising out of or relating to any violation of these Terms or any activity related to use of the Site (including but not limited to infringement of third parties’ worldwide intellectual property rights or negligent or wrongful conduct) by you or any other person accessing the Site on your behalf.
     
  6. Privacy. We do not collect personally identifying information from visitors to the Site unless you voluntarily decide to provide it to us through one of the provided e-mail addresses. Visitors are invited to make inquiries about Amryt and Aegerion and our research, or to inquire about job opportunities. We will use the information you provide us in those communications to respond to your inquiry, but will not use or disclose it in any other way without your express consent, except to contractors or service providers who may provide services or perform functions on our behalf – for example, an information technology service provider or human resources consultant. Those contractors and service providers are permitted to use your personal information only for the purpose for which it has been provided and may not disclose it to any other third party except at our express direction and consistently with this paragraph. This paragraph applies only to information collected from visitors through the Site and not to personal information that Amryt or Aegerion may collect in its research or through any off-line or other activities.
     
  7. Copyright and Trademarks. Copyright (C) 2020 Amryt Pharma Plc. All Rights Reserved. AMRYT, AEGERION, AEGERION PHARMACEUTICALS, JUXTAPID, LOJUXTA and MYALEPT trademarks and logos, and any other logo or trademark of Amryt or Aegerion, are logos trademarks and/or registered trademarks of either Amryt Pharma Plc or Aegerion Pharmaceuticals, Inc. and protected under the laws of the United States and other countries.
     
  8. Contacting Us. To inquire about linking to the Site or about trademark or copyright matters or if you have any questions or concerns about these Terms, please contact us at dpo@amrytpharma.com 
     
  9. This Site Does Not Provide Medical or Professional Services Advice. The content on the Site is intended to be a general information resource in regard to the subject matter covered. Amryt does not directly or indirectly practice medicine, render medical advice, or dispense medical services via the Site, and nothing contained in the Site is intended to be instruction for medical diagnosis or treatment. Any information provided should not be considered complete, nor should it be relied on to suggest a course of treatment for a particular individual. Information received from the Site should not be relied upon for personal, medical, legal, technical, or financial decisions. It should not be used in place of a visit, call, consultation or the advice of your physician or other qualified healthcare provider. Should you have any healthcare related questions, please consult with your physician or other qualified healthcare provider promptly.
     
  10. UpdatesAmryt and Aegerion may make improvements and/or changes to the Site at any time. Although we attempt to periodically update information on this Site, the information, materials and services provided on or through this Site may occasionally be inaccurate, incomplete or out of date. Amryt and Aegerion does not have a duty to update information contained in the Site, and we will not be liable for any failure to update such information. We make no representation as to the completeness, accuracy or currentness of any information on the Site, and we undertake no obligation to update or revise the information contained on the Site, whether as a result of new information, future events or circumstances or otherwise. It is your responsibility to verify any information contained in the Site before relying upon it.

 

 

 

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.

 

Photographs on this website feature people with GL and their caregivers.