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OCALIVA® (obeticholic acid) is a prescription medicine that treats adults with PBC in combination with ursodeoxycholic acid (UDCA) or alone if UDCA is not tolerated.
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.
OCALIVA® (obeticholic acid) is a prescription medicine that treats adults with PBC in combination with ursodeoxycholic acid (UDCA) or alone if UDCA is not tolerated.
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:
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:
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:
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:
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.
Choose the guide that is right for you to start a discussion with your healthcare team. Each guide provides useful questions to ask your healthcare provider to help you make an informed decision about your treatment plan.
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