What are the side effects of Obeticholic acid?

Obeticholic acid (Obeticholic acid) is indicated for the treatment of adults with primary cholangitis (PBC), including the absence of cirrhosis or for compensated cirrhosis without evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA), ineffective against UDCA, or as monotherapy in patients who cannot tolerate UDCA.

The most common side effects include pruritus, fatigue, and abdominal pain/discomfort, Other reported side effects include rash, oropharyngeal pain, dizziness, constipation, arthralgia, dyslipidemia, headache, eczema, depression, allergic reactions, and thyroid dysfunction. The incidence of pruritus has shown a dose-dependent increase and is higher when obeticholic acid is used as monotherapy; however, if patients receive obeticholic acid for three months without pruritus, side effects are unlikely to occur. If pruritus occurs, it can be controlled by adding bile acid sequestrants, antihistamines, reducing the dose, or temporarily interrupting dosing. Esophageal varices and ascites were also hepatic adverse events in a 3-year interim analysis of patients in the POISE trial.

The original drug of obeticholic acid has not yet been marketed in the country, so it has not been included in medical insurance. The original obeticholic acid drug marketed overseas is expensive, with each box costing around tens of thousands of yuan. The price is also affected by exchange rates and is unstable. It is understood that obeticholic acid has been produced as a generic drug and its ingredients are basically the same as those of the original drug. For example, the price of 5mg*30 tablets produced by a Bangladesh pharmaceutical factory is around RMB 1,000 per box (the price may fluctuate due to the exchange rate), and the price is cheap. For more drug information and specific prices, please consult a medical consultant.