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OCALIVA for
primary biliary cholangitis (PBC)

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

FXR, farnesoid X receptor.

 
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About PBCClick
Here

More about critical PBC biomarkers

How OCALIVA WorksClick
Here

Discover what an FXR agonist can do

EfficacyClick
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See the significant response

SafetyClick
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View the safety profile

DosingClick
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Up-titrating from 5 mg to 10 mg

Patient
Profiles
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Appropriate patients and response

Getting StartedClick
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Access and Support Resources

About PBC How Ocaliva Works Efficacy Safety Dosing Patient Profiles Getting Started
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Early Treatment of PBC Is Critical3

Understanding how alkaline phosphatase and early intervention are related to outcomes can make a positive impact3-5

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

More About PBC

 
PBC, primary biliary cholangitis.

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The First Drug in Its
Class for PBC1,2

OCALIVA, an FXR agonist, is a first-in-class therapy for the treatment of PBC1

Discover How OCALIVA Works View The Video
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Significant Alkaline
Phosphatase Reductions1

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

aPercentage of patients achieving the primary endpoint assessed at month 12, defined as alkaline phosphatase <1.67x the upper limit of normal (ULN), an alkaline phosphatase decrease ≥15%, and total bilirubin ≤ ULN.

see the efficacy data
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Safety and Tolerability

The most common adverse reactions from subjects taking OCALIVA (≥5%) were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema1

View the Safety Profile
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Once-Daily, Oral Dosing1

The starting dose is 5 mg, which is up-titrated to 10 mg after 3 months based on tolerability and response1

Learn More About Dosing
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Help Patients Start and Stay on Therapy

When you choose OCALIVA for your patients, Interconnect® provides comprehensive, personalized support for you and your patients

Get your patients started
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References

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2016.
  2. URSO [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; 2013.
  3. Kuiper EMM, Hansen BE, De Vries RA, et al; for the Dutch PBC Study Group. Improved prognosis of patients with primary biliary cirrhosis that have a biochemical response to ursodeoxycholic acid. Gastroenterology. 2009;136(4):1281-1287.
  4. Lammers WJ, van Buuren HR, Hirschfield GM, et al; on behalf of the Global PBC Study Group. Levels of alkaline phosphatase and bilirubin are surrogate end points of outcomes of patients with primary biliary cirrhosis: an international follow-up study. Gastroenterology. 2014;147(6):1338-1349.
  5. Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ. Primary biliary cirrhosis. Hepatology. 2009;50(1):291-308.

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