Obeticholic Acid
Uses of Obeticholic Acid
- Obeticholic Acid is a farnesoid X receptor (FXR) agonist used to treat primary biliary cholangitis (PBC), a rare, chronic liver disease that causes progressive damage to the bile ducts inside the liver.
Obeticholic Acid is commonly used for:
1. Primary biliary cholangitis (PBC) first-line combination therapy: Used alongside ursodeoxycholic acid (UDCA) in adults with PBC who have not responded adequately to UDCA alone, to help reduce abnormal liver enzyme levels and slow disease progression.
2. Primary biliary cholangitis monotherapy: Used on its own in adults with PBC who are unable to tolerate UDCA, as an alternative treatment to manage the condition.
3. Reduction of liver inflammation and fibrosis: Helps reduce ongoing inflammation and the development of scar tissue (fibrosis) in the liver associated with PBC, which if left untreated can progress to cirrhosis.
Side effects of Obeticholic Acid
Itching (pruritus)
Fatigue
Abdominal pain and discomfort
Skin rash
Throat pain (oropharyngeal pain)
How Obeticholic Acid works
- Obeticholic Acid works by activating a protein in liver cells called the farnesoid X receptor (FXR), which plays a central role in regulating bile acid production and liver health.
- In primary biliary cholangitis, the bile ducts in the liver become progressively damaged, causing bile acids to accumulate. This build-up is toxic to liver cells and triggers inflammation and scarring over time.
- By activating FXR, Obeticholic Acid reduces the liver's production of bile acids and promotes their excretion from the body. This helps lower the toxic concentration of bile acids in the liver, reducing the damage they cause to bile duct cells.
- In addition to regulating bile acid levels, FXR activation also has anti-inflammatory and antifibrotic effects, helping to reduce liver inflammation and slow the development of scar tissue (fibrosis) that can eventually lead to cirrhosis if the disease is left untreated.
Certified content
Written By
Doctor of Medicine
Reviewed By
BAMS, FMC, MD Resident
Expert Advice
Dosage Forms Available
Obeticholic Acid is available for use via the oral route in the form of tablets.
Age and Dose Restrictions
This medicine is intended for use in adults. Its safety and efficacy have not been established in paediatric patients.
Contraindications
Obeticholic Acid is contraindicated in patients with complete biliary obstruction.
It should also not be used by patients with a history of chronic liver disease or prior decompensation.
Other Medications to Avoid
Obeticholic acid can interact with medications affecting liver enzymes (such as rifampin, ketoconazole), anticoagulants (such as warfarin, dabigatran), and medications affecting bile acid levels (such as cholestyramine, colesevelam).
Overdose and Missed Dose
- An overdose of Obeticholic Acid may cause serious liver-related complications, including liver injury, jaundice (yellowing of the skin or eyes), worsening fluid accumulation in the abdomen (ascites), and a flare of primary biliary cholangitis symptoms. If an overdose is suspected, inform your doctor immediately or seek emergency medical attention without delay.
If you miss a dose of Obeticholic Acid, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed one.
Management of Side Effects
Most side effects are temporary and generally harmless and resolve when discontinuing this medicine. However, if you experience any severe side effects or worsening of any of the symptoms, please consult your doctor.
Drinking plenty of fluids can help manage constipation.
Resting or reducing activity can help manage fatigue.
For itching, over-the-counter creams or lotions can provide temporary relief.
Use in Driving and Operating Machinery
Obeticholic Acid may cause dizziness. If you experience this side effect, avoid driving or operating heavy machinery until you feel well enough.
Use in Pregnancy and Lactation
The use of this medicine during pregnancy or breastfeeding is not recommended without a doctor's advice. It is best to consult your doctor before taking this medication if you are pregnant or nursing.
Caution in Other Conditions
Patients with moderate or severe liver impairment (Child-Pugh B or C) should exercise caution when taking Obeticholic Acid.
Special Dietary and Lifestyle Recommendations
Regular monitoring of liver function is recommended for patients taking Obeticholic Acid.
Patients should maintain a balanced diet with a sufficient intake of proteins, vitamins, and minerals to support liver health.
It is advised to avoid activities that may lead to further liver damage, such as excessive alcohol consumption.
Regular physical activity can help maintain general health and well-being.
Frequently asked questions
Does Obeticholic Acid contain any steroids?
No, Obeticholic Acid does not contain any steroids. It is a farnesoid X receptor (FXR) agonist used for managing primary biliary cholangitis (PBC), which is a chronic liver disease.
Is there a particular time at which Obeticholic Acid should be taken?
Obeticholic Acid can be taken at any time of the day, with or without food. However, if you are also taking a bile acid sequestrant, ensure to separate the doses by at least 4 hours.
How long does it usually take for Obeticholic Acid to start working?
The time taken for Obeticholic Acid to start working can vary from person to person. However, it is important to note that it is not a fast-acting medicine and it might take several weeks or even months before you start noticing its effects.
Can Obeticholic Acid affect fertility?
There is currently no scientific evidence to suggest that Obeticholic Acid affects fertility. However, if you have concerns about fertility and are using this medication, you should consult your doctor for advice.
Can Obeticholic Acid be used long term?
Yes, it is often used long-term to manage chronic liver conditions, but regular monitoring by your doctor is necessary to assess effectiveness and side effects.
Does Obeticholic Acid affect appetite?
Obeticholic Acid may cause gastrointestinal side effects like nausea or abdominal pain, which could indirectly affect appetite in some individuals.
Is a prescription required to buy Obeticholic Acid?
Yes, a prescription is required to buy Obeticholic Acid as it is a prescription medicine.
List of medicines for Obeticholic Acid
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