What should you pay attention to when taking obeticholic acid?

In the clinical study of obeticholic acid (Obeticholic acid) in the treatment of primary cholangitis (PBC), warnings and precautions such as liver decompensation and failure, severe pruritus, and reduced HDL-C in patients with cirrhosis of PBC appeared. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Liver decompensation and failure in patients with PBC cirrhosis: It is reported that obeticholic acid treatment in patients with primary cholangitis cirrhosis, whether in the compensated or decompensated stage, can lead to liver decompensation and failure, which can sometimes be fatal or lead to liver transplantation. At the same time, hepatotoxicity was also observed in clinical studies. Hepatic adverse reactions include jaundice, worsening of ascites, and attacks of primary biliary cholangitis, as early as one month after starting treatment, mainly in patients with early-stage PBC.

2. Severe itching: Severe itching is defined as intense or widespread itching that interferes with activities of daily living, or causes severe sleep disturbance, or intolerable discomfort, usually requiring pharmaceutical intervention. In clinical trials of obeticholic acid, the incidence of severe pruritus was 0% at months 0-6 and 15% at months 6-12. Consider clinical evaluation of patients with new or worsening severe pruritus. Management strategies include adding bile acid-binding resins or antihistamines, reducing their dosage, and/or temporarily interrupting dosing.

3. Reduced HDL-C: Patients with primary cholangitis usually exhibit hyperlipidemia, which is characterized by a significant increase in total cholesterol, mainly due to elevated levels of high-density lipoprotein cholesterol (HDL-C). In clinical trials of obeticholic acid, a dose-dependent decrease in meanHDL-C levels from baseline was observed. Monitor changes in the patient's blood lipid levels during treatment. For patients who have not responded to obeticholic acid after 1 year on the highest recommended dose as tolerated (up to 10 mg once daily), and for patients with reduced HDL-C, weigh the potential risks and benefits of continued treatment.