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Track your progress on OCALIVA

Tracking your progress along the way can help show how OCALIVA® (obeticholic acid) is working for you.

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

Work with your healthcare team

Your healthcare team can help you set your primary biliary cholangitis (PBC) treatment goals. One of the key goals of treatment is to slow the progression of PBC.

Learn more about treatment goals

Monitoring your PBC

Historically, doctors would track ALP and bilirubin to see how well your PBC treatment was working and if anything needed to be adjusted. However, monitoring your liver health means looking at your disease progression, liver biomarkers, liver stiffness, and treatment response.

What are these key biomarkers?

  • A protein made in the liver that enters your bloodstream and keeps fluid from leaking out of your blood vessels into other tissues; when levels drop, it may suggest cirrhosis development.

  • An enzyme found in the liver and bone, which is important for breaking down proteins; elevated levels could mean liver disease.

  • An enzyme found in the liver that helps convert proteins into energy for the liver cells. When the liver is damaged, ALT is released into the bloodstream and levels increase.

  • An enzyme that helps the body break down amino acids; AST can be elevated as a result of damage to tissues of the body, including the liver. AST is also known as serum glutamic oxaloacetic transaminase.

  • A yellow bile pigment formed during the breakdown of red blood cells, it’s processed by the liver and excreted in stool; when the liver is not working properly, bile can accumulate in the blood and tissues of the body and can make the skin, and sometimes the eyes, appear yellow (jaundice).

  • This enzyme is typically the first liver enzyme to rise in the blood when bile ducts become obstructed and is used as a confirmatory test to determine if a high ALP is due to liver disease.

  • These cells help your blood form clots (think scabs when you get a cut). Low platelet counts are common in people with cirrhosis.

Tracking key biomarkers and fibrosis

Key biomarkers can be measured with simple blood tests. Your healthcare team can provide you with a copy of the results so you can keep track of your levels over time.

Healthcare provider expert guidelines recommend checking blood liver tests every 3 to 6 months.

Tracking fibrosis (liver stiffness) can be done with a liver ultrasound, a noninvasive imaging test.

Fibrosis progression should be measured every 12 to 24 months, depending on how you are responding to treatment.

Photograph of an actual patient.

“I make a graph of my biomarker levels so I can see where it started and how it’s going.”

Rosalía, a person living with PBC

Photograph of an actual patient.

Always take OCALIVA exactly as prescribed by your healthcare provider.

PBC is a lifelong condition—it’s important to stick to your treatment plan to manage PBC most effectively.

Your healthcare team may decide to increase your dose of OCALIVA. If you tolerate OCALIVA well and your healthcare provider thinks you could further lower your ALP level, he or she may increase your dose from 5 mg to 10 mg after 3 months or more of treatment.

Always talk to your healthcare team before making any changes to your treatment.

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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.