Prescribing Information

Interconnect® Support Services
Privacy Policy

Last Modified: February 2016

Intercept’s Commitment to Privacy

Intercept Pharmaceuticals, Inc. (“Intercept” or “we”) respects individual privacy and values the confidence of users of this website. This Privacy Policy describes the personal information Intercept collects about you on the INTERCONNECT SUPPORT SERVICES website (the “Site”); how we use that information; how we protect it; and the choices you may make with respect to your personal information. Intercept strives to collect, use, and disclose personal information in a manner consistent with the laws of the countries in which it does business. Accordingly, you are not required to provide any personal information to use this Site. Any information you do provide through this Site will be maintained in a reasonably secure manner and will only be used or disclosed in a manner consistent with the purposes for which you provide the information or as otherwise disclosed to you.

The Information We Collect

Some functions of our Site may allow you to voluntarily supply us with personal information, including your name, email address, and other contact information. You may decline to provide your personal information but, as a result, you may not have access to or the benefit of those features. Intercept also may retain electronic communications you send through the Site or through links provided on the Site.

Intercept also may track website information about visits to this Site. For example, statistics are compiled that show the daily requests received for particular files on the Site and what countries those requests come from. These aggregated statistics are used to customize our Site to better meet your needs and may also be provided to other parties.

We may use “cookies” or “web beacons.” A “cookie” is an element of data that a website can send to your browser which may be stored on your computer, device, or system. Cookies allow us to better serve visitors to our website by offering a tailored experience. A “web beacon,” also referred to as a “spotlight” or “pixel tag,” is used to recognize unique cookies and assist us in determining which advertisements bring users to a specific website or page. You can set your browser to notify you when you receive a cookie, giving you the chance to decide whether to accept it. If you decline to accept the cookie, it will also disable the web beacon. Intercept, from time to time, permits third parties to apply cookies when you visit the Site. However, the Site gives you a means to control how they are placed and used. You may be able to use “Do Not Track” features of the browser used to access this Site. Different browsers use different methods to communicate such “Do Not Track” signals; the industry has not yet adopted a uniform method to do so. For this reason, our Site may not be able to interpret or respond to “Do Not Track” signals.

Your information may be stored on third-party data storage systems and, in those instances, Intercept requires those third parties to employ security practices and systems designed to protect the security of the information.

How We Use Your Information

Intercept (and third parties acting on Intercept’s behalf) may use the information you submit to: (i) contact you; (ii) improve the Site; (iii) personalize your experience on the Site; (iv) comply with legal requirements; (v) provide you with information or services that you have requested; (vi) provide you with additional information that Intercept believes may be of interest to you; (vii) improve products and services; (viii) facilitate your contact with and access to support services; and (ix) identify individuals who have benefitted from or recommend our products and services. Any lists used to provide you information are designed to protect the privacy and security of your personal information. Intercept will use reasonable efforts to address all requests to remove names from any postal mail or email lists.

We may use or share aggregate data (information about our base of users in general, from which Personal Identifiable Information has been removed) for any purpose.

Disclosure

Because Intercept considers the personal information we maintain to be confidential, our policy is to disclose no personal information other than as we may inform you, including as described in this Policy, where such disclosure is required by law or is pertinent to a judicial or government action or investigation. In addition, Intercept may disclose information to third parties that assist Intercept in administering the Site and the communications made through the Site. Intercept does not otherwise sell or rent personal information to other persons or entities except as specifically disclosed at the point of collection.

Transfer of Data to Other Countries

This site is designed and intended for use only by residents of the United States. If you access this site from outside of the United States, be aware that any information you provide through the Site may be stored and processed, transferred between, and accessed from the United States and other countries which may not guarantee the same level of protection of personal information as the one in which you reside. However, Intercept will handle your personal information in accordance with this Privacy Policy regardless of where your personal information is stored or accessed. Please note that Intercept is certified to the Swiss-US and EU-US Privacy Shield with respect to certain categories of personal information collected by entities located in the European Economic Area and Switzerland and transferred to Intercept in the United States.
Click here to read Intercept’s Privacy Shield Policy.

Other Websites

This Site may contain links to other websites, and we make every effort to link only to sites that share our high standards and respect for privacy. However, Intercept is not responsible for the content of or the privacy practices employed by those other sites, so we recommend that you read the privacy policies and terms associated with these third-party websites carefully.

Children’s Privacy

Intercept does not knowingly collect any personal information (such as name, address, and telephone number) from children under 13 years of age through its Site. Intercept will specifically instruct children under 13 not to submit such information to this Site. We do not currently allow children under 13 to enroll in any support services accessible through information or forms provided on this Site. However, if the parent or guardian of a child under 13 believes that their child has provided us with personally identifiable information, that parent or guardian should contact us if they want this information deleted from our systems. If Intercept obtains knowledge that it has personally identifiable information about a child under 13 in retrievable form in its files, we will delete that information from our existing files. In addition, anyone under 18 years of age should seek his/her parent’s or guardian’s permission prior to using or disclosing any personal information on this Site.

Security Policies

We use certain security measures in an attempt to safeguard your personal and other information from unauthorized access or use. No such measure is ever entirely effective at all times, so we do not guarantee that your personal and other information will be secure from theft, loss, or unauthorized access or use, and we make no representation as to the reasonableness, efficacy, or appropriateness of the measures we use to safeguard such information.

Updates to Our Privacy Policy

From time to time we may update and post revisions to this Privacy Policy. Any changes will be effective immediately upon the posting of the revised Privacy Policy. Minor changes to the policy may occur without notice or consent that will not significantly affect our use of personal information. We encourage you to periodically review this page for the latest information on our privacy practices. This Privacy Policy was updated as of the effective date listed above.

Your California Privacy Rights

California Civil Code Section 1798.83, also known as the “Shine the Light” law, permits California residents to request and obtain once a year, free of charge, information about the personal information (if any) that Intercept disclosed to third parties for direct marketing purposes in the preceding calendar year. If applicable, this information would include a list of the categories of personal information that was shared and the names and addresses of all third parties with which we shared information in the immediately preceding calendar year. If you are a California resident and would like to make such a request, please email your request to privacyprotection@interceptpharma.com.

Disclaimer

By using this Site, you signify your assent to this Privacy Policy. If you do not agree to this Privacy Policy, please do not use this or other Intercept sites. Please check this page periodically for changes. Your continued use of the Site following the posting of changes to this Privacy Policy will mean that you accept those changes.

Contact Us

If you have any questions or concerns about the way your Personally Identifiable Information is used and handled, please e-mail us at privacyprotection@interceptpharma.com.


Important Safety Information
What is the most important information I should know about OCALIVA?

OCALIVA may cause serious side effects including:

Worsening of liver problems, liver failure, in some cases leading to death, have happened in people with PBC with advanced liver cirrhosis when OCALIVA was taken more often than recommended.

If you have primary biliary cholangitis (PBC) with advanced cirrhosis, you may need a lower dose of OCALIVA. Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide how much OCALIVA you should take and how often you should take it. If you have worsening liver problems, your dose of OCALIVA may be changed, stopped for a period of time, or stopped completely by your healthcare provider.

Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

  • Swelling of your stomach area from a build-up of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like “coffee grounds”; or mental changes (such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality)

Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

  • Stomach-area pain, nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue, weakness, fever, or chills; light-headedness; less frequent urination
Who should not take OCALIVA?

Do not take OCALIVA if you have or had a complete blockage in the bile ducts in your liver or gallbladder.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects including:

  • See “What is the most important information I should know about OCALIVA?
  • Severe Itching. Itching (pruritus) is a common side effect and can sometimes become severe (intense itching or itching all over your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities, and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse.
  • Decreases in Good Cholesterol. Decreases in HDL-C (“good cholesterol”) have been observed in patients taking OCALIVA. Your healthcare provider will check your cholesterol levels during treatment to see if you should continue taking OCALIVA.

The most common side effects of OCALIVA include: pruritus (itching of the skin), tiredness, stomach pain and discomfort, rash, joint pain, mouth and throat pain, dizziness, constipation, swelling in your hands, ankles or feet, fast or irregular heartbeat, fever, changes in how your thyroid gland works, and eczema (skin dryness, irritation, redness, crusting, or drainage).

These are not all the possible side effects associated with OCALIVA. Call your healthcare provider for medical advice about side effects.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.

What is OCALIVA?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Please see Medication Guide and full Prescribing Information, including Boxed Warning, for OCALIVA 5 mg and 10 mg tablets.

Available by prescription only.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OCALIVA?

OCALIVA may cause serious side effects including:
Worsening of liver problems, liver failure, in some cases leading to death, have happened in people with PBC with advanced liver cirrhosis when OCALIVA was taken more often than recommended.

Expand
Important Safety Information
What is the most important information I should know about OCALIVA® (obeticholic acid)?

OCALIVA may cause serious side effects including:

Worsening of liver problems, liver failure, in some cases leading to death, have happened in people with PBC with advanced liver cirrhosis when OCALIVA was taken more often than recommended.

If you have primary biliary cholangitis (PBC) with advanced cirrhosis, you may need a lower dose of OCALIVA. Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide how much OCALIVA you should take and how often you should take it. If you have worsening liver problems, your dose of OCALIVA may be changed, stopped for a period of time, or stopped completely by your healthcare provider.

Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

  • Swelling of your stomach area from a build-up of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like “coffee grounds”; or mental changes (such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality)

Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

  • Stomach-area pain, nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue, weakness, fever, or chills; light-headedness; less frequent urination
Who should not take OCALIVA?

Do not take OCALIVA if you have or had a complete blockage in the bile ducts in your liver or gallbladder.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects including:

  • See “What is the most important information I should know about OCALIVA® (obeticholic acid)?
  • Severe Itching. Itching (pruritus) is a common side effect and can sometimes become severe (intense itching or itching all over your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities, and usually needs to be treated.
  • Decreases in Good Cholesterol. Decreases in HDL-C (“good cholesterol”) have been observed in patients taking OCALIVA. Your healthcare provider will check your cholesterol levels during treatment to see if you should continue taking OCALIVA.

The most common side effects of OCALIVA include: pruritus (itching of the skin), tiredness, stomach pain and discomfort, rash, joint pain, mouth and throat pain, dizziness, constipation, swelling in your hands, ankles or feet, fast or irregular heartbeat, fever, changes in how your thyroid gland works, and eczema (skin dryness, irritation, redness, crusting, or drainage).

These are not all the possible side effects associated with OCALIVA. Call your healthcare provider for medical advice about side effects.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.

Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for OCALIVA.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is OCALIVA® (obeticholic acid)?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. There are ongoing studies to find out how OCALIVA works over a longer period of time.

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Important Safety Information
What is the most important information I should know about OCALIVA® (obeticholic acid)?

OCALIVA may cause serious side effects including:

Worsening of liver problems, liver failure, in some cases leading to death, have happened in people with PBC with advanced liver cirrhosis when OCALIVA was taken more often than recommended.

If you have primary biliary cholangitis (PBC) with advanced cirrhosis, you may need a lower dose of OCALIVA. Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide how much OCALIVA you should take and how often you should take it. If you have worsening liver problems, your dose of OCALIVA may be changed, stopped for a period of time, or stopped completely by your healthcare provider.

Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

  • Swelling of your stomach area from a build-up of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like “coffee grounds”; or mental changes (such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality)

Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

  • Stomach-area pain, nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue, weakness, fever, or chills; light-headedness; less frequent urination
Who should not take OCALIVA?

Do not take OCALIVA if you have or had a complete blockage in the bile ducts in your liver or gallbladder.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects including:

  • See “What is the most important information I should know about OCALIVA® (obeticholic acid)?
  • Severe Itching. Itching (pruritus) is a common side effect and can sometimes become severe (intense itching or itching all over your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities, and usually needs to be treated.
  • Decreases in Good Cholesterol. Decreases in HDL-C (“good cholesterol”) have been observed in patients taking OCALIVA. Your healthcare provider will check your cholesterol levels during treatment to see if you should continue taking OCALIVA.

The most common side effects of OCALIVA include: pruritus (itching of the skin), tiredness, stomach pain and discomfort, rash, joint pain, mouth and throat pain, dizziness, constipation, swelling in your hands, ankles or feet, fast or irregular heartbeat, fever, changes in how your thyroid gland works, and eczema (skin dryness, irritation, redness, crusting, or drainage).

These are not all the possible side effects associated with OCALIVA. Call your healthcare provider for medical advice about side effects.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.

Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for OCALIVA.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is OCALIVA® (obeticholic acid)?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. There are ongoing studies to find out how OCALIVA works over a longer period of time.