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.

Important Safety Information

LIMITATIONS OF USE:

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.

JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of JUXTAPID if the ALT or AST are ≥3x ULN. Discontinue JUXTAPID for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the JUXTAPID REMS Program.

Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

CONTRAINDICATIONS:

  • Pregnancy
  • Concomitant administration of moderate or strong CYP3A4 inhibitors
  • Moderate or severe hepatic impairment or active liver disease including unexplained persistent elevations of serum transaminases

WARNINGS AND PRECAUTIONS

JUXTAPID can cause elevations in transaminases and hepatic steatosis. Although cases of hepatic failure have not been reported, there is concern that JUXTAPID could induce steatohepatitis, which can progress to cirrhosis over several years. Modify the dose of JUXTAPID if elevations of transaminases are observed and discontinue JUXTAPID for persistent or clinically significant elevations. If transaminase elevations are accompanied by clinical symptoms of liver injury, such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like-symptoms, increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause. Use JUXTAPID with caution when co-administered with agents known to be hepatotoxic. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment. During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. After the first year, do these tests at least every 3 months and before any increase in dose.

JUXTAPID may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a negative pregnancy test before starting JUXTAPID and should use effective contraception during therapy with JUXTAPID. The recommended maximum dosage of JUXTAPID is 40 mg daily when used concomitantly with oral contraceptives.

Given its mechanism of action in the small intestine, JUXTAPID may reduce the absorption of fat- soluble nutrients. Patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. Instruct patients to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs, or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness. In such cases, consider reducing the dose or suspending use of JUXTAPID. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Weak CYP3A4 inhibitors can increase the exposure of lomitapide approximately 2-fold; therefore, when JUXTAPID is administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half and the recommended maximum dosage of JUXTAPID is 30 mg daily. The recommended maximum dosage is 40 mg daily when used concomitantly with oral contraceptives. Strong and moderate CYP3A4 inhibitors should not be used with JUXTAPID. Patients taking JUXTAPID 5 mg daily may continue with the same dosage.

Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary diseases of galactose intolerance.

ADVERSE REACTIONS:

The most common adverse reactions were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions reported by 8 (28%) or more patients in the HoFH clinical trial included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions, reported by 5 to 7 (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue.

REPORTING OF ADVERSE REACTIONS:

All healthcare professionals should report all suspected adverse reactions. Please contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see accompanying Prescribing Information including BOXED WARNING.

Important Safety Information

LIMITATIONS OF USE:

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.

JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of JUXTAPID if the ALT or AST are ≥3x ULN. Discontinue JUXTAPID for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the JUXTAPID REMS Program.

Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

CONTRAINDICATIONS:

  • Pregnancy
  • Concomitant administration of moderate or strong CYP3A4 inhibitors
  • Moderate or severe hepatic impairment or active liver disease including unexplained persistent elevations of serum transaminases

WARNINGS AND PRECAUTIONS

JUXTAPID can cause elevations in transaminases and hepatic steatosis. Although cases of hepatic failure have not been reported, there is concern that JUXTAPID could induce steatohepatitis, which can progress to cirrhosis over several years. Modify the dose of JUXTAPID if elevations of transaminases are observed and discontinue JUXTAPID for persistent or clinically significant elevations. If transaminase elevations are accompanied by clinical symptoms of liver injury, such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like-symptoms, increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause. Use JUXTAPID with caution when co-administered with agents known to be hepatotoxic. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment. During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. After the first year, do these tests at least every 3 months and before any increase in dose.

JUXTAPID may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a negative pregnancy test before starting JUXTAPID and should use effective contraception during therapy with JUXTAPID. The recommended maximum dosage of JUXTAPID is 40 mg daily when used concomitantly with oral contraceptives.

Given its mechanism of action in the small intestine, JUXTAPID may reduce the absorption of fat- soluble nutrients. Patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. Instruct patients to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs, or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness. In such cases, consider reducing the dose or suspending use of JUXTAPID. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Weak CYP3A4 inhibitors can increase the exposure of lomitapide approximately 2-fold; therefore, when JUXTAPID is administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half and the recommended maximum dosage of JUXTAPID is 30 mg daily. The recommended maximum dosage is 40 mg daily when used concomitantly with oral contraceptives. Strong and moderate CYP3A4 inhibitors should not be used with JUXTAPID. Patients taking JUXTAPID 5 mg daily may continue with the same dosage.

Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary diseases of galactose intolerance.

ADVERSE REACTIONS:

The most common adverse reactions were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions reported by 8 (28%) or more patients in the HoFH clinical trial included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions, reported by 5 to 7 (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue.

REPORTING OF ADVERSE REACTIONS:

All healthcare professionals should report all suspected adverse reactions. Please contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see accompanying Prescribing Information including BOXED WARNING.