PRIVACY POLICY

The pages on the website (the “website”) are published by Open Health (“Open Health”) who are a Data Processor on behalf of Amryt Pharma plc and its subsidiaries (“Amryt”, “us” or “we”) who are a Data Controller.

This Global Privacy Statement (the “Privacy Statement”) sets forth the commitment of Amryt to comply with applicable international, federal, state, and local laws and regulations protecting Personal Data that we process. This Privacy Statement applies to Amryts websites, social media pages, as well as other Amryt services that display or refer to this Privacy Statement (together “Services”). Any person accessing, browsing or otherwise using the Services, either manually or via an automated device or program, shall be considered a “User.”

All Users are bound to the terms of this Notice and to any specific terms of use associated with the applicable Service. Your use of Amryt Services means you consent to the collection, use and disclosure of your Personal Data as described in this Privacy Statement. 

Personal Data” means any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity. We recognise the importance of and are committed to respecting and protecting your privacy. This Privacy Statement applies to our collection and use of personal information through our website and through our offline business-related interactions with you, which, in the course of its ordinary business activities, Amryt may collect or receive. 

The collection, storage, adaptation or alteration, transfer, use, deletion, and other processing of Personal Data will be governed nationally, internationally, and regionally by data protection laws and regulations, such as the EU General Data Protection Regulation (GDPR).

In our globalized marketplace, the laws and standards of many countries must be considered when undertaking the collection, storage and transfer of Personal Data. When in doubt, please consult an appropriate internal resource, such as Legal, Compliance or Human Resources.

PURPOSE FOR WHICH WE HOLD YOUR INFORMATION

Amryt will not collect any Personal Data about individuals, except where it is specifically and knowingly provided by them.

When you visit Amryts website, Open Health’ web server collects some basic information such as your internet service provider’s domain name, which pages you accessed on the site, and when. We and Open Health use this information only to analyse the use of our website to help guide improvements. We do not collect any personally identifiable information.

DISCLOSURE OF YOUR INFORMATION TO THIRD PARTIES

If you register for the alert service, you will need to provide your name and email address. This information will be held by Investis and may be accessed by Investis Corporate Communications PVT. Ltd (a subsidiary of Investis) from its premises in India for administration of the alert service.

The information disclosed will not be used for any other purpose. It will be stored securely and will not be shared with third parties. By registering for the alerts, you consent to this use of your name and email address.

We may also disclose your information if we believe in good faith that we are required to disclose it in order to comply with any applicable law, a summons, a search warrant, a court or regulatory order or other statutory or legal requirement.

COOKIES

When you visit Amryts website, Open Health uses cookies, which are small pieces of information that allow them to maintain your connection to the website. This website may use cookies for detecting what kind of device you have in order to present content in the best way, for a language switch and/or for other purposes. These cookies do not collect or store any personally identifiable information. You can refuse the use of cookies.

GOOGLE ANALYTICS

This website uses Google Analytics, a web analytics service provided by Google, Inc. (‘Google’). Google Analytics uses cookies (text files placed on your computer) to help the website operators analyse how users use the website. The information generated by the cookie about your use of the website (including your IP address) will be transmitted to and stored by Google on servers in the United States. Google will use this information for the purpose of evaluating your use of the website, compiling reports on website activity for website operators and providing other services relating to website activity and internet usage. Google may also transfer this information to third parties where required to do so by law, or where such third parties process the information on Google’s behalf. Google will not associate your IP address with any other data held by Google. By using this website, you consent to the processing of data about you by Google in the manner and for the purposes set out above. How to refuse the use of cookies

You may refuse the use of cookies by selecting the appropriate settings in your browser. However, if you do this you may lose some useful functionality such as personalisation and ‘keep me signed in’ and ‘remember me’ features.

How to disable cookies in your browser

SECURITY

The transmission of information via the internet is not completely secure. We cannot guarantee the security of your data transmitted to our online services; any transmission is at your own risk. Once we have received your information, we will take reasonable steps to use procedures and security features to try to prevent unauthorised access, modification or disclosure.  

If you communicate with us using a non-secure web platforms, you assume the risks that such communications between us are intercepted, not received, delayed, corrupted or are received by persons other than the intended recipient. We will, however, take all reasonable steps (including appropriate technical and organisational measures) to protect your data.

In the event your personal data is accessed, lost, or stolen by an unauthorized third party, we will exercise commercially reasonable efforts to notify you to the extent required by law and disclose to you the personal data that was accessed/disclosed using the contact information provided to us or by other reasonable means.

YOUR RIGHTS

The privacy laws of some jurisdictions give individuals the right to access, amend or delete their personal information or, in some circumstances, to restrict the processing of their personal information.

If you would like to request a copy of your data or would like to change or erase all or any part of the information we hold about you, please contact us as via the ‘Contact Us’ section of the website.  We may refuse to provide access and may charge a fee for access if the relevant legislation allows us to do so, in which case we will provide reasons for our decision as required by law.

Third-Party Services

 

This Privacy Statement does not address, and Amryt is not responsible for the terms of use, information or privacy practices of any third parties, including any third party operating any website or service to which our Amryt website links. The inclusion of a link on the Amryt website does not imply our or our affiliates’ endorsement of the linked website or service.

CHANGES

Any changes to this statement will be posted on this website so you are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose 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, Instructions for Use 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, Instructions for Use and full Prescribing Information including Box Warning.

 

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