Update

2018 AASLD guidance recommends OCALIVA as the only approved second-line treatment option for PBC3 SEE THE GUIDELINES

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OCALIVA for primary biliary cholangitis (PBC)

An FXR agonist and the first treatment approved for PBC in 20 years1,2

AASLD, American Association for the Study of Liver Diseases; FXR, farnesoid X receptor.

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Efficacy Click
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See the significant response

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START AT 5 mg

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Assessing Response in PBC Click
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Learn More About Critical Biomarkers

About PBC How Ocaliva Works Efficacy Safety Patient Profiles Getting Started
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Significant, Sustained Alkaline Phosphatase Reductions1

OCALIVA® (obeticholic acid) efficacy OCALIVA® (obeticholic acid) efficacy

When used in combination with UDCA or as monotherapy, OCALIVA delivered significant and sustained reductions in alkaline phosphatase1,b

See the efficacy data

bSignificant efficacy in patients achieving the primary endpoint, defined as alkaline phosphatase <1.67x the upper limit of normal (ULN), an alkaline phosphatase decrease ≥15%, and total bilirubin ≤ ULN.

ALP, alkaline phosphatase.

Dosing for OCALIVA

Starting dose for OCALIVA is 5 mg once daily for non-cirrhotic or compensated Child-Pugh Class A patients. Up-titrate as recommended based on tolerability and response.

Starting dose for patients with Child-Pugh Class B or C, or a prior decompensation event, is 5 mg once weekly.

Learn More About Dosing

OCALIVA obeticholic acid OCALIVA obeticholic acid

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References:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2018.
  2. URSO [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; 2013.
  3. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. In press.
OCALICA obeticholic acid

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OCALIVA® (obeticholic acid)

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