Obetan 5mg/10mgfilm-coated tablets

1.What OBETAN is and what it is used for

OBETAN is a drug for the treatment of primary biliary cholangitis (PBC) in adults. OBETAN is to be used

*with another drug called ursodeoxycholic acid in patients whose liver enzyme tests do not adequately improve after using ursodeoxycholic acid for an appropriate period of time or

*on its own when patients cannot take ursodeoxycholic acid because of side effects

HOW OBETAN works

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory,fibrotic, and metabolic pathways, FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing denovo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes, These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.

2.Recommended Dosing

*Starting Dose: 5 mg orally once daily.

*Titration: After 3 months, if ALP/total bilirubin levels do not improve adequately and side effects are tolerated, increase to 10 mg once daily.

*Maximum Dose: 10 mg/day (do not exceed).

3.Common Side Effects

Skin itching, fatigue, abdominal pain/discomfort, joint pain, throat pain, dizziness, constipation.