Obeticholic Acid

Obeticholic Acid is a medication belonging to the class of farnesoid X receptor (FXR) agonists. It is used for the treatment of certain liver conditions, specifically primary biliary cholangitis (PBC). PBC is a chronic liver disease where the bile ducts in the liver are gradually destroyed, leading to liver damage. Obeticholic Acid is is a farnesoid X receptor (FXR) agonist.

Indications

It s indicated for the treatment of adult patients with primary biliary cholangitis (PBC) • without cirrhosis or • with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. Dosage:- oral; The recommended dosage of Obeticholic Acid for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA follows below: • Start with a dosage of 5 mg once daily for the first 3 months. After the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating Obeticholic Acid, increase to a maximum dosage of 10 mg once daily. -Obeticholic Acid is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in those who are unable to tolerate UDCA.

Dosage

The recommended dosage of Obeticholic Acid is usually determined by a healthcare professional and may vary based on individual patient factors. It is typically taken orally once daily with or without food.

Contra-Indications

In patients who • develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy). • have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). • experience clinically significant hepatic adverse reactions. • develop complete biliary obstruction -Obeticholic Acid is contraindicated in patients with complete biliary obstruction and those with a history of liver decompensation.

Special Precautions

-Special precautions should be taken in patients with severe liver impairment, and regular monitoring of liver function tests is recommended during treatment. It is important to inform healthcare providers of any pre-existing conditions, medications, or allergies before starting Obeticholic Acid. Paediatric: The safety and effectiveness of Obeticholic Acid in pediatric patients have not been established. Pregnancy: Data not sufficient Lactation: Data not sufficient Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Side Effects

-Common side effects may include pruritus (itching), fatigue, and abdominal pain. Serious side effects such as liver-related complications may occur, and immediate medical attention is required if symptoms like jaundice or worsening liver function develop. -Hepatic Decompensation and Failure in PBC Patients with Cirrhosis, Severe Pruritus, Reduction in HDL-C

Drug Interactions

-Obeticholic Acid may interact with certain medications, including bile acid sequestrants, cyclosporine, and some hormonal contraceptives. It is crucial to inform healthcare providers of all medications being taken to avoid potential interactions. -Bile acid binding resins such as cholestyramine, colestipol, or colesevelam, warfarin, theophylline, cyclosporine