How to take obeticholic acid correctly?

Obeticholic acid (Obeticholic acid) is a drug specifically used to treat primary biliary cholangitis (PBC). Before starting obeticholic acid, physicians need to conduct a thorough liver function evaluation to ensure that they do not have symptoms of decompensated cirrhosis or compensated cirrhosis with portal hypertension.

For patients with PBC without cirrhosis or with only compensated cirrhosisThe recommended initial dose is 5 mg orally once daily for 3 months. During this period, patients need to ensure that they have no signs of portal hypertension and have failed to show an adequate biochemical response to an appropriate dose of ursodeoxycholic acid (UDCA) within the past year, or have an intolerance to UDCA. If after 3 months of initial treatment, the patient's alkaline phosphatase (ALP) and/or total bilirubin levels have not decreased significantly and the patient is able to tolerate the treatment, the dose can be increased to 10 mg daily, which is the maximum dose.

In terms of medication management, obeticholic acid can be taken with food or on an empty stomach. If the patient is taking bile acid binding resin, it is recommended to take it at least 4 hours before or after taking obeticholic acid to avoid interaction between the two. In addition, in patients with moderate or severe hepatic impairment (eg, Child-Pugh class B or C), the starting dose is usually adjusted to 5 mg per week.

During treatment, it is important to regularly monitor the patient's liver function. If there are signs of hepatic decompensation or associated portal hypertension, or if the patient experiences significant adverse reactions, use of the drug should be discontinued immediately. In addition, for patients who cannot tolerate a daily dose of 5 mg, it can be adjusted to 5 mg every other day, or for patients who cannot tolerate 10 mg daily, adjust it back to 5 mg daily. There is also the option of temporarily interrupting treatment, if necessary, for a maximum of two weeks, and then gradually restarting it and increasing the dose based on the patient's biochemical response and tolerance.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdfbe0cd-eb15-45a1-ac17-531bcda21aec