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Obeticholic Acid: Brands, Price & Uses in Bangladesh
Obeticholic Acid is a Farnesoid X receptor (FXR) agonist used in the treatment of primary biliary cholangitis (PBC) (formerly known as primary biliary cirrhosis), a chronic autoimmune liver disease.
About Obeticholic Acid
Indications of Obeticholic Acid
Obeticholic Acid is a Farnesoid X receptor (FXR) agonist used in the treatment of primary biliary cholangitis (PBC) (formerly known as primary biliary cirrhosis), a chronic autoimmune liver disease.
Established / approved use
- Treatment of primary biliary cholangitis in adults without cirrhosis or with compensated cirrhosis and no evidence of portal hypertension, used:
- In combination with ursodeoxycholic acid (UDCA) in patients who have had an inadequate response to UDCA alone after at least one year of therapy, or
- As monotherapy in patients who are unable to tolerate UDCA.
Not indicated / restricted use
- Obeticholic Acid is not indicated for patients with decompensated cirrhosis or cirrhosis with evidence of portal hypertension because of the risk of serious hepatic decompensation (see Precautions and Warnings).
Regulatory status note
Following long-term confirmatory trial data that did not show a favourable overall benefit-risk profile as second-line PBC therapy, major regulators have taken restrictive action on Obeticholic Acid: the European Medicines Agency revoked its EU marketing authorisation in 2024, and the US marketing authorisation holder voluntarily withdrew Obeticholic Acid from the US market in 2025. Availability and approved indications for Obeticholic Acid can therefore vary by country; confirm current local regulatory and marketing status with a physician or pharmacist before starting or continuing treatment.
Dosage & Administration of Obeticholic Acid
Primary biliary cholangitis (adults)
| Step | Dose | Notes |
|---|---|---|
| Initial dose | 5 mg orally once daily | Given alone or with ursodeoxycholic acid (UDCA) |
| Dose adjustment (after 3 months) | Increase to 10 mg once daily (maximum) if response is inadequate and the 5 mg dose is well tolerated | Assessed using liver biochemistry (e.g. alkaline phosphatase, bilirubin) and tolerability |
| If 5 mg dose not tolerated | Continue at a reduced frequency as directed by the physician | Dose-related pruritus is common; see Side Effects |
Hepatic impairment
Obeticholic Acid requires close hepatology supervision in any degree of hepatic impairment. It is not indicated in patients with decompensated cirrhosis or cirrhosis with portal hypertension (see Contraindications and Precautions and Warnings). Where used in mild compensated cirrhosis, treatment should begin at the lowest dose with more frequent clinical and laboratory monitoring.
Missed dose
If a dose of Obeticholic Acid is missed, it should be taken as soon as remembered unless the next dose is nearly due, in which case the missed dose should be skipped — do not double the dose.
Side Effects of Obeticholic Acid
The most common side effect of Obeticholic Acid is pruritus (itching), which is dose-related and can be severe enough to require dose reduction or discontinuation in some patients.
Common
- Pruritus (very common)
- Fatigue
- Abdominal pain and discomfort
- Joint pain (arthralgia)
- Throat irritation, dizziness, constipation
- Rash, eczema
- Reduced HDL cholesterol
- Elevated liver enzymes
Serious (see Precautions and Warnings)
- Hepatic decompensation/liver failure — particularly in patients with cirrhosis, requiring urgent medical attention.
Contraindications of Obeticholic Acid
- Known hypersensitivity to Obeticholic Acid or any component of the formulation.
- Complete biliary obstruction.
Obeticholic Acid is also not indicated for use in decompensated cirrhosis or cirrhosis with portal hypertension because of a serious risk of hepatic decompensation and failure in this population (see Precautions and Warnings).
Frequently Asked Questions about Obeticholic Acid
What is Obeticholic Acid used for?
Obeticholic Acid is used to treat primary biliary cholangitis (PBC), a chronic liver disease, usually in combination with ursodeoxycholic acid (UDCA) when response to UDCA alone is inadequate, or alone in patients who cannot tolerate UDCA.
Why does Obeticholic Acid cause itching?
Pruritus (itching) is a very common, dose-related side effect of Obeticholic Acid. It can often be managed with dose adjustment or additional medication under a physician's guidance, but severe itching should be reported to your doctor.
Can Obeticholic Acid affect my liver?
Yes. Obeticholic Acid carries a serious risk of hepatic decompensation and liver failure, particularly in patients with cirrhosis or portal hypertension. Regular liver function monitoring is required during treatment, and Obeticholic Acid is not indicated in patients with decompensated cirrhosis or portal hypertension.
Is Obeticholic Acid still available everywhere?
Regulatory status has changed in some countries: the EU revoked its marketing authorisation for Obeticholic Acid in 2024, and it was voluntarily withdrawn from the US market in 2025 due to an unfavourable long-term benefit-risk assessment. Ask your physician or pharmacist about the current approval and availability status of Obeticholic Acid in your country.
Can I take Obeticholic Acid during pregnancy or while breastfeeding?
Obeticholic Acid should be used in pregnancy only if clearly needed, as data are limited, and a physician should be consulted about breastfeeding, since it is not known whether Obeticholic Acid passes into breast milk.
What should I do if I miss a dose of Obeticholic Acid?
Take the missed dose as soon as you remember, unless it is almost time for your next dose — in that case, skip the missed dose and continue your normal schedule. Do not take a double dose of Obeticholic Acid.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.