৳ 55/unit
Pack: ৳ 1,650
৳ 55/unit
Pack: ৳ 1,650
At a glance
Obeticholic Acid is a Farnesoid X Receptor (FXR) agonist used for primary biliary cholangitis (PBC). It activates FXR to reduce bile acid synthesis and increase bile acid transport out of hepatocytes, reducing hepatic bile acid exposure.
Indications
- Primary biliary cholangitis (PBC) — in patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension
- In combination with UDCA in patients with inadequate response or as monotherapy in patients unable to tolerate UDCA
Pharmacology
Obeticholic acid activates FXR to suppress de novo bile acid synthesis in the liver and increase transport of bile acids out of hepatocytes, reducing hepatic bile acid exposure and limiting the circulating bile acid pool.
Dosage
Adult Dose (Oral):
- Noncirrhotic or compensated Child-Pugh A: 5 mg/day for first 3 months; increase to 10 mg/day if adequate response not achieved and tolerated
- Child-Pugh B or C, or prior decompensation: 5 mg once weekly; increase to 5 mg twice weekly (at least 3 days apart) if adequate response not achieved and tolerated; may titrate to 10 mg twice weekly based on response and tolerability
Side effects
Common Side Effects (>10%):
- Pruritus (56-70%)
- Fatigue (19-25%)
- Severe pruritus (19-23%)
- Reduced HDL-C (9-20%)
- Abdominal pain and discomfort (10-19%)
Uncommon (1-10%):
- Rash, oropharyngeal pain, dizziness, constipation, peripheral edema, palpitations, pyrexia, thyroid function abnormality, eczema
Use in pregnancy
Use in Pregnancy: Limited human data on use during pregnancy; no developmental abnormalities observed in animal studies.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Precautions & warnings
- Hepatic decompensation and failure reported in patients with decompensated cirrhosis (Child-Pugh B/C) or prior decompensation event
- Contraindicated in compensated cirrhosis with evidence of portal hypertension (ascites, gastroesophageal varices, persistent thrombocytopenia)
- Monitor for elevations in liver enzymes and risks for hepatic decompensation
- Monitor HDL-C
Overdose effects
Overdose: Dose-dependent hepatic adverse reactions (liver enzyme elevations, ascites, jaundice, portal hypertension); monitoring and supportive care.
Storage conditions
Store below 30°C in a dry place, protect from light; keep out of reach of children.