OBETAS® is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
either in combination with ursodeoxycholic acid with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate ursodeoxycholic acid.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
How it 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 de novo 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.
Indications
OBETAS® is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
either in combination with ursodeoxycholic acid with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate ursodeoxycholic acid.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Dosage
Prior to the initiation of OBETAS, healthcare providers should determine whether the patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C), has had a prior decompensation event, or has compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) because OBETAS is contraindicated in these patients
Recommended Dosage Regimen
Side Effects
Most common adverse reactions (≥ 5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema
Contraindication
Copyright © 2020 tasmed
.png)
