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Results with OCALIVA

OCALIVA® (obeticholic acid) is the first add-on treatment for primary biliary cholangitis (PBC) trusted for 9 years.

Leslie, 61 Joined #TeamOCALIVA in 2017Photograph of an actual patient.

In a 12-month clinical study

~5x more patients who took OCALIVA showed
a response to treatment*

UDCA alone
(73 out of 216 patients)

10%

of patients responded to treatment

OCALIVA 5 mg→10 mg†
(70 out of 216 patients)

46%

of patients responded to treatment

OCALIVA 10 mg
(73 out of 216 patients)

48%

of patients responded to treatment

Treatment response was defined by:

  • ALP was less than 1.67 times the upper limit of normal‡
  • ALP decreased by at least 15%
  • Bilirubin levels were within the normal range§

Average ALP levels in both OCALIVA treatment groups were reduced by more than 30% in 1 year vs ~5% with UDCA alone*

Some people taking OCALIVA saw a reduction in ALP levels as early as 2 weeks after starting treatment

  • *In the study, patients taking OCALIVA were also taking UDCA, except for 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA titration arm, and 5 patients (7%) in the placebo arm.
  • †In the 5 mg→10 mg titration group, 36 patients stayed at 5 mg and 33 were titrated to 10 mg after 6 months.
  • ‡Many liver health markers such as ALP have a range of values that are considered normal. The top of that range is called the upper limit of normal.
  • §Bilirubin is a separate marker of overall liver health. It is measured with a blood test. Bilirubin levels are more likely to be increased in people with PBC with advanced disease and liver damage.
  • ALP, alkaline phosphatase; UDCA, ursodeoxycholic acid.

  • Study details

    Who: Adults with PBC (ages 29 to 86, mean age 56) who were taking UDCA for at least 12 months, or who were not able to tolerate UDCA and did not receive UDCA for at least 3 months

    Criteria: Patients qualified for this trial if their ALP was 1.67 times the upper limit of normal or higher and if their bilirubin was greater than 1 times the upper limit of normal but less than 2 times the upper limit of normal

For over 6 years, the impact of OCALIVA on markers of cholestasis and inflammation, and on fibrosis, has been studied

After 1 year of treatment, patients either added OCALIVA to UDCA or continued treatment with OCALIVA and UDCA for an additional 5 years. This is known as the Open‑Label Extension Study. Within this study, changes were observed across multiple markers of disease.

Limitations of the study:

  • ”Open-label“ means both the person administering the drug and the person taking the drug were aware the drug in the study was OCALIVA, and “extension” means it was a continuation of the original study
  • This study also had no comparison group, which means these results may not be as reliable and no clinical conclusions can be made

There are ongoing studies to assess outcomes with OCALIVA over the long term.

Photograph of an actual patient.

What do these numbers mean to you?

During routine blood work, your doctor may order different tests to check the values of various markers of liver health and whether they are within the reference range (or less than ULN, which refers to the upper limit of normal).

OCALIVA works alone, too

For some patients who cannot tolerate UDCA, taking OCALIVA without UDCA (known as monotherapy) also produces meaningful results.

OCALIVA is here for you

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Actual patients featured on this website are paid spokespeople for Intercept Pharmaceuticals.

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.