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Potential side effects of OCALIVA

Side effects are possible with any prescription medication, including OCALIVA® (obeticholic acid).

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

The most common side effects of OCALIVA include:

  • Pruritus
    (itching of the skin)
  • Fatigue
    (feeling tired all over)

Other common side effects include stomach pain and discomfort, rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function, and eczema (inflammation of the skin).

These are not all the possible side effects associated with OCALIVA. Tell your healthcare team about any side effects you experience. Ask them about any lifestyle changes, prescription medications, or over-the-counter medications or products that may help.

What is pruritus?

Pruritus is itching of the skin. It affects most people with primary biliary cholangitis (PBC),
even if they do not have a rash or other skin conditions.

Up to 70% of people with PBC experience pruritus.

What should I know about potential side effects?

Pruritus is a common symptom of PBC and can also be a side effect of taking OCALIVA—generally appearing within the first month of treatment. When discussing a pruritus management plan with your doctor, remember to keep your PBC treatment goals top of mind.

In a clinical study of OCALIVA, only 1% of people who started on 5 mg discontinued treatment due to pruritus* vs 10% of people who started on 10 mg; no patients in the placebo group discontinued.

  • *1 patient out of 70 (1%) discontinued in the 5→10 mg group, 7 out of 73 (10%) discontinued in the 10 mg group, and no patients in the placebo group (n=73) discontinued.

97% of people (193 out of 198) who completed the study at 12 months chose to continue taking OCALIVA in a long-term follow-up study.†

  • †Of 198 patients who completed the double-blind phase, 193 (97%) elected to enter the open-label extension.

Throughout treatment with OCALIVA, more pruritus days were mild than moderate or severe. OCALIVA may still be working even if you continue to experience fatigue and itchiness. Always talk to your healthcare team before making any changes to your PBC treatment.

What is the most important information I should know about taking 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.

Need help managing your side effects? Speak with your doctor.

Choose the discussion guide that best describes you to help you have the right conversation with your doctor.

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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.