This website (the “Website”) is the website of Amryt Pharma plc (“Amryt”, “us” or “we”). The pages on the Website are published by Open Health  (“OpenHealth”) on behalf of Amryt.

Please read these terms and conditions of use of the Website carefully as by using the Website you agree to be bound by them. We reserve the right to vary the conditions of use at any time and will post any variations here. You are advised to review the conditions of use on a regular basis as you will be deemed to have accepted variations if you continue to use the Website after they have been posted.

Your Responsibility

 

You assume all responsibility for your use of, or access to, this Website, including your access to any Amryt or other literature obtained through the Site, and waive all claims or causes of action against Amryt or their respective the officers, directors, employees, agents and affiliates in connection therewith. If you do not agree to abide by these conditions of use you should not use the Website in any way.

Third-Party Resources

 

This Website may contain links to websites operated by other parties. The linked sites are not under the control of Amryt or OpenHealth, and we are not responsible for the content available on any other Internet sites linked to this Website. Such links do not imply our endorsement of material on any other site, and Amryt and OpenHealth disclaim all liability with regard to your access to such linked websites. Amryt and OpenHealth may provide links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this Website is at your own risk. Information published by Open Health on the Website is supplied by Amryt and, where indicated, by certain third parties. Open Health and Amryt take every care and precaution to ensure that information published on the Website is accurate when posted and regularly updated, but neither Open Health nor Amryt guarantees or can be held liable for its accuracy or timeliness and Open Health or Amryt may change the information at any time without notice. You must not rely on the information on the Website and you acknowledge that you must take appropriate steps to verify this information before acting on it.

Disclaimer

AMRYT AND OPEN HEALTH PUBLISH THE WEBSITE “AS IS” WITHOUT ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, AS TO THE OPERATION OF THE WEBSITE, THE ACCURACY OF THE INFORMATION OR THE PRODUCTS OR SERVICES REFERRED TO ON THE WEBSITE (IN SO FAR AS SUCH WARRANTIES MAY BE EXCLUDED UNDER ANY RELEVANT LAW) AND TO THE EXTENT PERMITTED BY LAW, NEITHER AMRYT NOR OPENHEALTH SHALL BE LIABLE FOR ANY LOSSES OR DAMAGE WHETHER DIRECT OR INDIRECT (INCLUDING, WITHOUT LIMITATION DIRECT OR INDIRECT LOSS OF PROFITS), CONSEQUENTIAL, SPECIAL OR OTHERWISE INCIDENTAL THAT MAY RESULT FROM USE OF THE WEBSITE HOWSOEVER ARISING. WE FURTHER 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

Indemnity

 

You agree to indemnify, defend and hold harmless Amryt and OpenHealth, 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 Website (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 Website on your behalf.

The information contained in the Website is not an invitation to invest in shares or other securities, or any other products or services or otherwise deal in these or enter into a contract with Amryt or any other company. The information provided should not be relied upon in connection with any investment decision. You should always seek appropriate professional advice in relation to such.

The past performance of Amryt or any other company referred to on the Website cannot be relied upon as a guide to its future performance. The price of shares and the income derived from them can go down as well as up and investors may not recoup the amount originally invested.

Any reference to any product or service which has been or may be provided by Amryt or any other company does not amount to a promise that such product or service will be available at any time. Changes to or improvements in such products or services may be made at any time without notice.

Copyright

Copyright in the design and architecture of the Website is owned by Open Health. Amryt owns the copyright and trademarks in the content published on the Website except where otherwise indicated by a third party’s proprietary notice. Images, trade-marks and brands are also protected by other intellectual property laws and may not be reproduced or appropriated in any manner without written permission of their respective owners. Unless specifically prohibited by a notice published on any page, you may make a print copy of such parts of the Website as you may reasonably require for your own personal use provided that any copy has attached to it any relevant proprietary notices and/or disclaimers. All other use is prohibited.

We are not responsible for the content of any other website from which you have accessed the Website or to which you may hyperlink from the website and cannot be held liable for any loss or damage you incur as a result thereof.

This Website Does Not Provide Medical or Professional Services Advice

 

The content on the Website 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 Website, and nothing contained in the Website 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 Website 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.

Forward-Looking Statements

 

The Website may contain express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management's plans, objectives, and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Amryt assumes no obligation to update any forward-looking statements contained in any press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

Updates

 

Amryt may make improvements and/or changes to the Website at any time. Although we attempt to periodically update information on this Website, the information, materials and services provided on or through this Website may occasionally be inaccurate, incomplete or out of date. Amryt do not have a duty to update information contained in the Website, 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 Website, and we undertake no obligation to update or revise the information contained on the Website, whether as a result of new information, future events or circumstances or otherwise. It is your responsibility to verify any information contained in the Website before relying upon it.

Governing Law

 

These conditions of use are governed by the laws of England and Wales and you agree that the English courts shall have exclusive jurisdiction in any dispute.

To the extent that any part of these conditions of use is found to be invalid, unlawful or unenforceable by any court of competent jurisdiction such part shall to that extent be severed from the remaining terms all of which shall remain in full force and effect as permitted by law.

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.