In studies most people who added OCALIVA® (obeticholic acid) to their UDCA saw alkaline phosphatase (ALP) levels lowered by more than 15%.a

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme 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.

Ursodeoxycholic acid, also known as URSO or UDCA, is the most common treatment for primary biliary cholangitis (PBC).

Taking OCALIVA with UDCA

OCALIVA - UDCA

  • OCALIVA does not interfere with how UDCA works, so the 2 medicines can be taken together.
    • After 6 months of taking UDCA, a routine blood test can determine whether or not the medicine is working adequately or if another option may help.

Taking OCALIVA alone

OCALIVA

  • Some people with PBC are unable to tolerate UDCA and require a different treatment option.
    • For people who are unable to tolerate UDCA, OCALIVA can be taken alone.
    • In addition, up to 40% of people with PBC may be “nonresponders” to treatment with UDCA, which means blood tests show they still have certain liver health markers that could be further improved.

aIn a study of OCALIVA, all participants with PBC were taking UDCA for at least 12 months or were unable to tolerate UDCA and did not receive it for at least 3 months.

"I keep a pill box, so I can remember to take my medicine, like it was prescribed by my doctor."

-Rosalía, a person living with PBC

Take the next step in your PBC treatment plan—
talk to your healthcare team to see if
OCALIVA may be right for you.

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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.