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Introducing OCALIVA® (obeticholic acid)

Q: What is OCALIVA, and who can take it?

A: OCALIVA is a once-daily pill for adults who have PBC. It can be taken in combination with another medicine called ursodeoxycholic acid (UDCA). For people who cannot tolerate UDCA, OCALIVA can be taken alone.

Q:Can I take OCALIVA if I am already taking UDCA to treat my PBC?

A:Yes. OCALIVA may be taken in combination with UDCA to help further lower alkaline phosphatase (ALP) levels.

Q:Can I take OCALIVA if I am taking other medicines?

A:Some medicines used to lower blood cholesterol levels, so-called bile acid resins (including cholestyramine, colestipol and colesevelam) may reduce the effectiveness of OCALIVA. If you are taking a bile acid resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible. Certain drugs such as warfarin and CYP1A2 substrates (including theophylline and tizanidine) can interact with OCALIVA, so it is important to tell your healthcare provider about all the medicines you take.

Q:Who should not take OCALIVA?

A:You should not take OCALIVA if you have been diagnosed with complete biliary obstruction. Talk to your healthcare provider to see if OCALIVA is right for you.

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Starting OCALIVA

Q:Who can help me get started on OCALIVA?

A:Your healthcare provider will determine if OCALIVA is right for you. Once you have a prescription for OCALIVA, you will be contacted by a Care Coordinator from Interconnect® who will help you get started.

Q:How much will OCALIVA cost me?

A:The Care Coordinators at Interconnect can help you find out how much of the cost of OCALIVA is covered by your insurance or any applicable financial assistance programs.

Q:How can I find out if my insurance will cover my OCALIVA prescription?

A:Interconnect is committed to providing access to OCALIVA to everyone who qualifies. You can reach out to an Interconnect Care Coordinator to get support for your prescription coverage.

Q:Do I have to go to my healthcare provider to get OCALIVA?

A:Yes. OCALIVA is a prescription medicine and cannot be accessed without a prescription.

Q:Who can I talk to if I have other questions about getting started on OCALIVA?

A:Once prescribed OCALIVA, Interconnect can help you get started.

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Side effects

Q:If I experience pruritus (itching of the skin) while I’m on OCALIVA, does that mean it’s not working?

A:No. The severity of pruritus and fatigue are not related to how far the disease has progressed. In fact, for some people, pruritus gets better as their liver health gets worse. The best way to tell if OCALIVA is working for you is to track your alkaline phosphatase (ALP) level over time. Guidelines recommend that you see your healthcare provider regularly to get your ALP level tested.

Q:What should I do if I experience pruritus while taking OCALIVA?

A:Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA. These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you experience any side effect that bothers you or does not go away.

Q:What should I do if I experience any side effects while taking OCALIVA?

A:Report to your healthcare provider immediately if you develop worsening symptoms. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA. These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you experience any side effect that bothers you or does not go away.

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

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Taking OCALIVA

Q:Do I need to take OCALIVA with food?

A:OCALIVA can be taken with or without food.

Q:How should I store OCALIVA?

A:OCALIVA should be stored at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC-30ºC (59ºF -86ºF).

Q:What should I do if I miss a dose of OCALIVA?

A:Talk to your healthcare provider if you miss a dose of OCALIVA.

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Tracking ALP

Q:How does OCALIVA work, and how will I know if it is working for me?

A:Take a look here to see how OCALIVA works. Your healthcare provider can see if OCALIVA is working for you by tracking the results from your liver function tests. Work with your healthcare provider to follow your progress and to make sure you are taking the dose of OCALIVA that works best to lower your alkaline phosphatase (ALP) level.

Q:What are “liver markers”?

A:Healthcare providers use blood tests to check for different enzymes that act as markers of liver health. For people with PBC, very important liver markers include ALP and bilirubin.

Q:Can OCALIVA help people who have already lowered their ALP levels with another medicine?

A:Yes. Studies suggest that some people who are already taking ursodeoxycholic acid (UDCA) can add OCALIVA to their treatment to further lower their ALP levels.

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver ALP. There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

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The information on this page is intended for informational purposes only and does not constitute medical advice. Always consult your healthcare team if you have any questions about your medical condition.

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IMPORTANT SAFETY INFORMATIONClick to expand

What is OCALIVA® (obeticholic acid)? OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself. The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Who should not take OCALIVA® (obeticholic acid)? Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once-daily up to 50 mg once-daily (up to 5-times the highest recommended dosage). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.
  • Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.
  • Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.

The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function and eczema (inflammation of the skin).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about:

  • all of your medical conditions
  • all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.

OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.

Especially tell your healthcare provider if you take:

  • Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.
  • Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.

Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.

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

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

What is OCALIVA® (obeticholic acid)? OCALIVA (obeticholic acid) is a prescription medicine used for the treatment of primary biliary cholangitis (PBC) in adult patients. OCALIVA is taken in combination with another medicine called ursodeoxycholic acid (UDCA), or, for people who cannot tolerate UDCA, OCALIVA can be taken by itself. The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme alkaline phosphatase (ALP). There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.

Who should not take OCALIVA® (obeticholic acid)? Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once-daily up to 50 mg once-daily (up to 5-times the highest recommended dosage). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.
  • Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.
  • Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.

The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function and eczema (inflammation of the skin).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about:

  • all of your medical conditions
  • all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.

OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.

Especially tell your healthcare provider if you take:

  • Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.
  • Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.
  • CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.

Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.

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

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.