Introducing OCALIVA® (obeticholic acid)

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

A: OCALIVA is a pill that can be prescribed 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:Do not take OCALIVA if you have or had a complete blockage in the bile ducts in your liver or gall bladder. 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.

Do you still have questions about OCALIVA?

Your healthcare team is your best resource when it comes to getting answers about your PBC treatment plan.

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IMPORTANT SAFETY INFORMATIONClick to expand

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
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.

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.

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.

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
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.

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.

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.