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Brand Name :
Ocaliva
Synonyms :
obeticholic acid
Class :
Farnesoid X Receptor Agonists
Brand Name :
Ocaliva
Synonyms :
obeticholic acid
Class :
Farnesoid X Receptor Agonists
Dosage Forms & Strengths
Tablet
5mg
10mg
Primary Biliary Cholangitis (Primary Biliary Cirrhosis)
Initially, 5 mg orally each day
Maintenance dose- 5 mg orally each day
If no reduction is seen in alkaline phosphatase or total bilirubin after 3 months, increase the dose to 10 mg orally each day
Maximum dose-10 mg each day
Safety and efficacy are not seen in pediatrics
Refer to the adult dosing; sensitivity may occur in older adults
Actions and Spectrum:
Actions
obeticholic acid binds to and activates the FXR, a nuclear receptor in various tissues, including the liver and intestine. Activation of FXR regulates gene expression and modulates several biological processes involved in metabolism, inflammation, and bile acid homeostasis.
Spectrum
obeticholic acid is being investigated for its potential therapeutic effects in other liver diseases, such as non-alcoholic steatohepatitis (NASH), which may help reduce liver inflammation and fibrosis. Clinical trials are ongoing to evaluate its efficacy and safety in these conditions.
Frequency defined
>10%
Abdominal pain (10-19%)
Fatigue (19-25%)
Severe pruritus (19-23%)
Pruritus (56-70%)
Reduced HDL-C (9-20%)
1-10%
Peripheral edema (3-7%)
Abnormal thyroid function (4-6%)
Eczema (3-6%)
Palpitations (3-7%)
Pyrexia (7%)
Rash (7-10%)
Dizziness (7%)
Constipation (7%)
Arthralgia (6-10%)
Oropharyngeal pain (7-8%)
Black Box Warning:
There is a risk of hepatic decompensation and failure in biliary cirrhosis.
Contraindication/Caution:
Contraindications
Cautions
Pregnancy consideration:
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Breastfeeding warnings:
Caution should be exercised while administering the drug to breastfeeding women.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
obeticholic acid acts as a selective agonist for FXR, a nuclear receptor in various tissues, including the liver, intestine, and adipose tissue. Activation of FXR regulates gene expression and modulates several biological processes.
Pharmacodynamics:
obeticholic acid is a selective agonist for FXR, a nuclear receptor found in multiple tissues, including the liver and intestine. Activation of FXR by obeticholic acid modulates gene expression and regulates various physiological processes.
Pharmacokinetics:
Absorption
The peak plasma concentration is acquired in 1.5 hours for obeticholic acid and 10 hours for active metabolites
Distribution
The peak urine concentration is achieved in 2-8 hours
Metabolism
The drug gets metabolized in the liver.
Elimination and Excretion
The drug is excreted at 3% in the urine and 87% in feces
Administration:
The prescribing healthcare professional will determine the dosage of obeticholic acid based on the specific condition being treated and individual patient factors.
Patient information leaflet
Generic Name: obeticholic acid
Why do we use obeticholic acid?
obeticholic acid is approved for treating PBC, a chronic autoimmune liver disease characterized by inflammation and destruction of the bile ducts in the liver. obeticholic acid is used in patients with inadequate response to or intolerance of ursodeoxycholic acid (UDCA), the first-line therapy for PBC. It can help improve liver function and reduce liver inflammation.
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