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Frequently asked questions

Want to learn more about OCALIVA® (obeticholic acid)?

Rosalía, 56 Joined #TeamOCALIVA in 2016Photograph of an actual patient.

Understanding primary biliary cholangitis (PBC)

  • PBC is a chronic (lifelong), progressive (can worsen over time) liver disease where your body's immune cells attack the bile ducts, causing a buildup of toxic bile acid. As a result, liver cells can be damaged with further inflammation, leading to liver scarring (fibrosis). Long-term fibrosis can result in end-stage liver disease (transplant or death). However, PBC is manageable with proper treatment.

    Learn more about PBC >

  • The most common symptoms are pruritus (itching of the skin) and fatigue (feeling tired all over). Some people may also experience dry eyes and mouth and trouble remembering or concentrating. Everyone experiences symptoms differently and some people may not experience symptoms. How severe your symptoms are is not related to how far PBC has progressed or how well your treatment is working.

  • No—PBC is chronic, which means it will not go away. It is important to start treatment early because medicine may work best in PBC that is in the early stages.

Introducing OCALIVA

  • OCALIVA® (obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with UDCA (also called ursodeoxycholic acid or ursodiol) 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. It is not known if OCALIVA is safe and effective in children.

    Learn more about OCALIVA >

  • Yes. OCALIVA may be taken in combination with UDCA (ursodeoxycholic acid) or alone. In fact, OCALIVA may even take your PBC treatment further than if you were to take UDCA alone.

    See how OCALIVA works alongside UDCA >

  • 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.

    If you take a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.

  • Do not take OCALIVA if you:

    • have PBC with liver cirrhosis with symptoms such as fluid in the stomach-area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver.
    • have a complete blockage of the bile ducts in your liver or gallbladder.

Taking OCALIVA

How OCALIVA works

  • OCALIVA works in a unique way to reduce toxic acid buildup by: limiting the amount of bile acids in your liver and increasing the flow of bile acids out of the liver. OCALIVA also improves markers of the different stages of PBC: bile acid buildup (cholestasis), liver cell damage (inflammation), and “liver stiffness” (fibrosis).

    See how OCALIVA works >

  • Average alkaline phosphatase (ALP) levels in both OCALIVA treatment groups were reduced by more than 30% in 1 year vs ~5% with UDCA alone.

Tracking PBC progression

  • 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 for you. It’s also important to monitor more than just alkaline phosphatase and bilirubin, as well as your “liver stiffness” (fibrosis), to assess liver health.

  • Healthcare providers use simple blood tests, done every 3-6 months, to check for multiple biochemical markers (biomarkers) including:

    • Alkaline phosphatase (ALP)
    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Bilirubin
    • Gamma-glutamyl transferase (GGT)

    In addition to these biomarkers, you should monitor fibrosis to see how well your liver is functioning.

  • Fibrosis can be measured using a liver ultrasound, such as FibroScan®. Liver ultrasounds are noninvasive procedures that can be done every 12-24 months depending on how you are responding to your treatment.

  • Yes. Studies suggest that some people who are already taking UDCA (also called ursodeoxycholic acid) can add OCALIVA to their treatment to lower alkaline phosphatase (ALP) even further.

    See OCALIVA results >

    There are ongoing studies to find out how OCALIVA works over a longer period of time.

  • One treatment goal of PBC is to normalize or near normalize biochemical marker (biomarker) levels and keep them there. Even with stable levels, if they remain high, you could be at risk for further disease progression.

Living with PBC and its symptoms

  • No. The severity of itchiness and fatigue is not related to how far the disease has progressed or how your treatment is working. The best way to tell if OCALIVA is working for you is to track your biochemical marker (biomarker) levels over time. Always talk with your healthcare team before making any changes to your PBC treatment.

    Learn more potential OCALIVA side effects >

  • There are a few proactive lifestyle changes that can help with managing pruritus, such as:

    • taking cool showers
    • wearing loose-fitting clothing
    • applying a daily moisturizer, such as Eucerin®
    • staying hydrated by drinking enough water

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

  • There are a few proactive lifestyle changes that can help manage fatigue, such as:

    • finding a good support system or group
    • staying social and avoiding situations that make you feel lonely
    • setting up an exercise routine (and starting slowly)

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

  • Report to your healthcare provider immediately if you develop worsening symptoms. Be sure to tell your healthcare provider if pruritus or fatigue develops or worsens during treatment with OCALIVA. These are not all the possible side effects 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.

Starting OCALIVA


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.

Still have questions about OCALIVA?

Your healthcare team is your best resource for answers about your PBC treatment plan. Choose the discussion guide that best describes you to help you have the right conversation with your doctor.

Download a discussion guide:

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Indication and Important Safety Information

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. It is not known if OCALIVA is safe and effective in children.

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

OCALIVA may cause serious side effects including:

Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking 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 if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA.

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”; 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 and chills; light‑headedness; less frequent urination

Who should not take OCALIVA?

Do not take OCALIVA if you:

  • have PBC with liver cirrhosis with symptoms such as fluid in the stomach‑area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver.
  • have a complete blockage of 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 (pruritus). Itching is a common side effect and can sometimes become severe (intense itching or itching over much of 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.
  • Lower HDL‑C (“good” cholesterol). OCALIVA can lower high levels of HDL‑C. Your healthcare provider will check your cholesterol levels during treatment with OCALIVA.

The most common side effects of OCALIVA include: 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; dryness, irritation, redness, crusting or drainage of the skin (eczema).

These are not all the possible side effects of OCALIVA. Call your doctor 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.

The risk information provided here is not complete. To learn more, please talk to your healthcare provider.

Please click here for Full Prescribing Information and Medication Guide for OCALIVA.

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.