Registered Kenya · PPB

LIVOBET® 10

OBETICHOLIC ACID

H2025/CTD11349/24175 OBETICHOLIC ACID 10 MG GENERIC/BIOSIMILARS

What it does

Obeticholic is a medication used to treat certain liver diseases by improving liver function.

Commonly used for: primary biliary cholangitis (PBC), liver disease

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2025/CTD11349/24175
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
OBETICHOLIC ACID
Strength
-
Pack size
3X10ALU-ALU BLISTER PACKED IN A CARTON WITH PRODUCT LEAFLET.
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Zuvan
Applicant / LTR
JAVIA INTERNATIONAL LIMITED
Country of origin
FOREIGN

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:23:18 · updated 2026-08-03 02:09:38

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Obeticholic is a medication used to treat certain liver diseases by improving liver function.

What it treats

  • primary biliary cholangitis (PBC)
  • liver disease

How it works

It works by reducing inflammation and helping to improve liver health.

Who it's for

This medication is for adults with specific liver conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: obeticholic

Obeticholic acid is a synthetic bile acid analog that acts as a farnesoid X receptor (FXR) agonist. It is primarily used in the treatment of primary biliary cholangitis, a chronic liver disease characterized by the progressive destruction of the bile ducts. By activating FXR, obeticholic acid regulates bile acid homeostasis and reduces inflammation and fibrosis in the liver.

Indications

  • Primary biliary cholangitis

Dosage

Adults: The usual adult dosage for obeticholic acid is 5 mg once daily, which may be increased to 10 mg once daily based on patient response and tolerability. Dosage adjustments may be necessary for patients with hepatic impairment.

Mechanism of action

Obeticholic acid activates the farnesoid X receptor (FXR), which regulates bile acid synthesis, transport, and metabolism. This activation leads to a decrease in bile acid synthesis in the liver, reduces hepatic inflammation, and promotes liver cell regeneration. Additionally, FXR activation enhances the production of fibroblast growth factor 19 (FGF19), which further inhibits bile acid synthesis and promotes glucose metabolism.

Pharmacodynamics

The pharmacodynamics of obeticholic acid involve its effects on the liver, particularly in modulating bile acid synthesis and secretion. Its action as an FXR agonist leads to decreased serum levels of bile acids, reduced hepatic inflammation, and improved liver histology in patients with primary biliary cholangitis. The clinical effects include improvement in liver function tests and a slowdown in disease progression.

Pharmacokinetics

Obeticholic acid is well absorbed after oral administration and is extensively metabolized in the liver. The primary metabolic pathway involves conjugation with glucuronic acid. The elimination half-life of obeticholic acid is approximately 13 hours, and it is primarily excreted in the feces. The pharmacokinetics can be affected by other medications, particularly those that influence hepatic metabolism.

Interactions

  • obeticholic acid and warfarin: Unknown (decreases anticoagulant effect)
  • obeticholic acid and coumarins: Unknown (decreases anticoagulant effect)
  • obeticholic acid and theophylline: Unknown (increases exposure)
  • obeticholic acid and tizanidine: Unknown (increases exposure)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.