Ocaliva (obeticholic acid)

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Ocaliva (obeticholic acid)

Ocaliva (obeticholic acid) is a medication for the treatment of primary biliary cholangitis (PBC).

How to buy Ocaliva (obeticholic acid): You can order Ocaliva (obeticholic acid) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

Hepatology Primary Biliary Cholangitis (PBC)
Marketing Authorisation Holder Intercept Pharma Ltd
Mode of Action Farnesoid X receptor (FXR) agonist
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA

What is Ocaliva (obeticholic acid) for?

Obeticholic acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA1

How does Ocaliva (obeticholic acid) work?

PBC is a chronic or long-lasting disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed. This causes bile to remain in the liver, damaging liver cells over time and resulting in cirrhosis, or scarring of the liver. As cirrhosis progresses and the amount of scar tissue in the liver increases, the liver loses its ability to function. Obeticholic acid, given orally, binds to the farnesoid X receptor (FXR), a receptor found in the nucleus of cells in the liver and intestines. FXR is a key regulator of bile acid metabolic pathways. Obeticholic acid increases bile flow from the liver and suppresses bile acid production in the liver, thus reducing the exposure of the liver to toxic levels of bile acids2.

Is Ocaliva (obeticholic acid) approved?

Obeticholic acid was approved for the treatment of patients with primary biliary cholangitis (PBC) by:

  • FDA (USA) on May 27, 20162
  • EMA (EU) on December 12, 20163

How do I take Ocaliva (obeticholic acid)?

The recommended therapy consists of:

  • Starting Dosage: the recommended starting dosage of obeticholic acid is 5 mg orally once daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA.
  • Dosage Titration: if an adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of obeticholic acid 5 mg once daily and the patient is tolerating obeticholic acid, increase dosage to 10 mg once daily.
  • Maximum Dosage: 10 mg once daily.

For the management of patients with intolerable pruritus or hepatic impairment see full prescribing information1.

Warning: Correct dosing is of the utmost importance. The FDA (USA) warns that incorrect dosing in some patients with moderate to severe decreases in liver function may result in an increased risk of serious liver injury and death5.

Complete information about obeticholic acid dosage and administration can be found in the resources section.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Ocaliva (obeticholic acid)?

Common adverse reactions

The most common adverse reactions (≥ 5%) listed in the prescribing information include:

  • pruritus
  • fatigue
  • abdominal pain and discomfort
  • rash
  • oropharyngeal pain (pain in the throat or in the ears)
  • dizziness
  • constipation
  • arthralgia (pain in joints)
  • thyroid function abnormality
  • eczema

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include: 

  • hepatic decompensation and failure in incorrectly dosed PBC patients
    with Child-Pugh Class B or C or decompensated cirrhosis

  • severe pruritus

  • reduction in HDL-C ("good cholesterol")

Use in a specific population

Dosage adjustment is required in patients with Child-Pugh-Class B and C or a prior decompensation event.

 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ocaliva (obeticholic acid) and any potential adverse effects on the breastfed infant.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information listed ion our resources section1,4.

More Information
Working ingredient obeticholic acid
Shipping method Standard (not temperature controlled)
Therapeutic Area Metabolic diseases
Hepatology Primary Biliary Cholangitis (PBC)
Administration Oral
Mode of Action Farnesoid X receptor (FXR) agonist
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Intercept Pharma Ltd
HS Code 29372900
CAS Number 459789-99-2

The approval is based on a 12 month trial involving 216 patients with PBC who were taking UDCA for at least 12 months and were on a stable dosage for at least 3 months; or patients who were unable to tolerate UDCA and did not receive it for at least 3 months. All patients had a level of Alkaline phosphatase (ALP – an enzyme fundamental for metabolism within the liver) at least 1.67 times higher than normal (with normal being 118U/L for females and 124 U/L for males); or had a level of bilirubin (a brownish yellow substance produced when the liver breaks down old red blood cells and found in bile) higher than normal but less than twice as normal (with normal being 1.1mg/ dL for females and 1.5mg/dL for males). Patients received either obeticholic acid 10mg for 12 months, or obeticholic acid 5mg for the first 6 months with the option of an escalation to 10mg for the last 6 months, or placebo. When possible patients took UDCA1.

Patients were considered responders if after 12 months their ALP was less than 1.67 times the normal and decreased of at least 15%, and if their bilirubin wasless or equal the normal level. At 12 months the responders on Ocaliva 10 mg were 48% (95% CI = 36–60), those on Ocaliva 5 mg with possibility to increase the dosage to 10 mg were 46% (95% CI = 34–58), and those on placebo were 10% (95% CI = 4–19)1

Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.