Amryt Pharma Plc, and its subsidiaries, including Aegerion Pharmaceuticals Inc, respect individual privacy and are committed to protecting personal information in conformity with applicable legal and ethical standards. This Privacy Policy sets forth our practices regarding the collection, use, and disclosure of information that you may provide through this site. Please read this entire Privacy Policy before using this site or submitting information to us through this site. By using this site and whenever you submit information through this site to us, you agree with the terms of this Privacy Policy written below.

We Collect Personal Information

We only collect personal information, such as your name, address, telephone number, or e-mail address, when you voluntarily submit it to us.

Cookies and Other Non-Personal Information

Cookies: We collect information about your usage of our site through cookies and similar technology. There are two types of cookies: session cookies (non-persistent cookies) and persistent cookies. Session cookies temporarily store non-personally identifiable information about your visit to our website in your computer’s memory. The cookie is deleted as soon as you close your browser. Persistent or permanent cookies will uniquely identify your browser and will permanently save in your computer’s memory information requested by the website. We may also use pixels, or transparent GIF files. These GIF files are provided by our ad management partner. These files would enable our ad management partners to recognize a unique cookie on your Web browser, which in turn would enable us to learn which advertisements bring users to our website.

With both cookies and transparent GIF files, the information that we collect and share is anonymous and not personally identifiable. It does not contain your name, address, telephone number, or e-mail address. Session Information: We also track the total number of visitors to our website, the number of visitors to each page of the website, and the domain names of our visitors’ Internet service providers. No personal information is gathered in any of these processes.

IP Address: We record the Internet Protocol (IP) address of your computer when you visit our site. We use analysis software to look at IP addresses only for the purpose of enhancing your user experience. This information is not used to develop a personal profile of you and the log files are regularly purged.

In some countries, you will need to log in with DocCheck to access the professional area of this website.  For information on how DocCheck uses your data visit http://info.doccheck.com/com/privacy/ . An encrypted value for validating your DocCheck login is stored in a cookie on your device until your session is closed. Beyond that, we do not store any data when registering via DocCheck. The Service/treatment centres page of this website uses Google-maps and your data will be collected by Google.  For more information on the purpose and scope of data collection and processing by Google, please see Google’s privacy policy: www.google.com/intl/de_en/policies/privacy/. This will also provide you with further information about your rights in this regard and setting options to protect your privacy.

How We Use This Information

We will not sell or share your name or any detailed information about you to independent companies so that those companies can solicit you for the purpose of selling their goods or services. We use the information about your use of the services and activities on our site to monitor user traffic patterns and try to analyze user preferences so that we can better tailor your site experience and customize the information provided to you by us for your specific interests.

Personal Information

You do not have to submit your personal information to access most of the information available to you on our site. However, if you choose to provide such information to us, we may use this information to follow up with you on specific matters or to provide you with information that you may be interested in, to provide you with technical assistance, or to respond to your questions. If you have indicated that you are interested in receiving information about our products and services, we and companies operating on our behalf (see below) may use your data to send you this information or contact you directly. We also may need to send you specific administrative notices about your account, and in some cases, we may need to use the information in order to contact you if required by law.

Cookies and Other Non-Personal Information

Cookies: Cookies allow us to bring you the content and features likely to be of greatest interest to you based on your previous activities on our site. In our sites that require passwords, you are giving us explicit permission to use a “persistent cookie,” which is a small data file that is generated when you enter your assigned user ID and password and access the site. This file is saved in your computer’s memory and enables your browser to access each page that is in the password-protected area. IP Address: In addition to using the IP address of your computer to maintain communications with you as you move about our site, we also may use your IP address to personalize content provided on the site.

How We Disclose Your Information

Our Relationships With Other Third-Party Companies: We may use third-party companies to provide services and information on the site (see the paragraph about vendors and suppliers above). We also may use third-party vendors or agents to analyze data collected on the site. If we allow a third-party contractor to have access to your information, they will only be permitted to take it or use it for purposes that are consistent with this Privacy Policy. In addition, these vendors and agents will have to ensure the confidentiality and security of their information processing and implement adequate measures to protect this information. As required by Law: In certain limited circumstances, we may be called upon to release your personal information in response to a court order, subpoena, search warrant, law, or regulation. We also may need to use your information to contact you if required by law. We plan to cooperate in responding to such requests, taking appropriate measures to ensure that the requester understands the sensitive nature of the information that they may receive. We also reserve the right to cooperate with law enforcement authorities in investigating and prosecuting users who violate our rules or engage in behaviour that is illegal or harmful to other users of the site. 

Other Disclosures: Other than as disclosed in this Privacy Policy, we will not use or disclose any personally identifying information you have provided to us to an unrelated third party without your consent.

Your Privacy Choices

Personal Information

If, at any time, you wish to stop receiving e-mails or other communications from us, or if you have submitted personal information through our site and would like to have that information deleted from our records, please notify us. You may also request access to personal data about you that we hold, and you may have the opportunity to request a correction or amendment to your personal data. Notify us directly at dpo@amrytpharma.com As a reminder to you when exchanging e-mails, any e-mail that you send or receive on your employer’s e-mail system may be the property of your employer. Consequently, your employer may have the ability to review your personal information sent via e-mail. Please note that although we attempt to adhere to requests to remove personal data from our records, it may not be possible to remove all copies depending on the manner in which the information was submitted to us. In addition, we reserve the right to not remove or amend information provided to us regarding an adverse drug effect, and information is otherwise required to be retained by law.

Cookies and Other Non-Personal Information

Your Web browser can be set to allow you to control whether you will accept cookies, reject cookies, or to notify you each time a cookie is sent to you. If your browser is set to reject cookies, sites like ours that are cookie-enabled will not recognize you when you return to the site and some site functionality may be lost.

Notice About Internet Security

While we make every reasonable effort to protect the information collected through its websites, including this site, please be aware that there is always some risk involved when submitting data over the Internet. We cannot guarantee that our website is 100% safe from illegal tampering or “hacking.” Any data transmitted over the Internet may be at risk; however, once it is received by us and entered into our database, it has the same protection that we extend to its own confidential information.

Links to Third-Party Sites

As a convenience to our visitors, our site currently contains links to a number of other sites that we believe may offer useful information. The Privacy Policy does not apply to those sites. These links are not under our control, and we are not responsible for the content of, or potential damage caused by, any hyperlinked sites. The inclusion of any link on an Aegerion site does not indicate or imply any endorsement by Aegerion of the hyperlinked sites. You should contact these sites directly for information on their privacy policies, confidentiality agreements, and data collection/distribution procedures. Please note that linked sites may also use cookies. We cannot control the use of cookies by these sites. In addition, when you link from our website to another website, that site may have the ability to recognize that you have come from our site. If you do not want any other websites to know that you have been on this website, we recommend that you do not use the links provided in our site.

Children‘s Policy

The site content and services are intended for adult users over the age of 13. The site is not designed to attract underage users. If we learn that an under-13 user has provided personal information, we will delete such information from our active databases.

Privacy Policy Updates

We will only use personal information in the manner described in the Privacy Policy in effect when the information was collected from you. However, we reserve the right to change the terms of this Privacy Policy at any time by posting revisions to the site. This privacy policy was last updated January 2020.

 

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.