Obeliva 5mg Tablet-30pcs Pot

Uses:

• Treats primary biliary cholangitis in adults

How does Obeliva 5mg Tablet work?

Obeticholic Acid helps improve liver function by reducing the production and build-up of bile in the liver and reducing inflammation.

Side Effects of Obeliva 5mg Tablet

Common adverse effects of Obeticholic Acid include severe itching (pruritus), fatigue, and abdominal discomfort or pain. Additional common side effects comprise skin rashes, joint pain (arthralgia), throat pain (oropharyngeal discomfort), dizziness, constipation, thyroid function changes, and skin inflammation (eczema).

Quick Suggestions:

• Take Obeliva 5mg Tablet as a whole with sufficient water.
• Always take this medicine exactly as prescribed by your doctor.
• Do not consume more than the prescribed dose.
• Do not discontinue the medicine on your own without consulting your doctor.

Indication of Obeliva 5mg Tablet

Obeliva 5mg Tablet is classified under a group of medicines known as farnesoid X-receptor agonists. It is employed in the treatment of primary biliary cirrhosis, also referred to as primary biliary cholangitis. Obeliva 5mg Tablet aids in enhancing liver function by decreasing the production and accumulation of bile in the liver, ultimately reducing inflammation and contributing to the treatment of primary biliary cirrhosis.

Pharmacology

Obeticholic Acid activates the FXR, a nuclear receptor found in the liver and gut. FXR plays a crucial role in regulating various pathways, including bile acid, inflammation, fibrosis, and metabolism. FXR activation reduces bile acid levels within liver cells by decreasing the production of cholesterol and enhancing the transport of bile acids out of the cells. These mechanisms help reduce exposure of the liver to bile acids and increase bile excretion.

Dosage & Administration of Obeliva 5mg Tablet

The recommended starting dose of Obeticholic Acid is 5 mg taken orally once daily for adult patients who haven't adequately responded to Ursodeoxycholic Acid (UDCA) over at least one year or who cannot tolerate UDCA.

Dosage Adjustment: If there's insufficient reduction in alkaline phosphatase (ALP) and/or total bilirubin levels after three months of taking Obeticholic Acid at 5 mg daily, and if the patient is tolerating it, the dosage can be increased to 10 mg once daily.

Maximum Dosage: The highest recommended dose of Obeticholic Acid is 10 mg taken once daily.

Managing Patients with Severe Itching (Pruritus) on Obeticholic Acid: For individuals experiencing severe itching while on Obeticholic Acid, the following options can be considered:

• Adding an antihistamine or bile acid binding resin.
• Reducing the Obeticholic Acid dosage to:
  • 5 mg every other day, for patients intolerant to 5 mg daily
  • 5 mg once daily, for patients intolerant to 10 mg daily
• Temporarily discontinuing Obeticholic Acid for up to two weeks, followed by restarting at a reduced dosage.

Interaction

Interactions Bile acid binding resins like cholestyramine, colestipol, or colesevelam can adsorb and inhibit bile acid absorption, potentially reducing the absorption, systemic exposure, and effectiveness of Obeticholic Acid. If taking a bile acid binding resin, Obeticholic Acid should be taken at least 4 hours before or after the resin, or at the earliest suitable interval. Warfarin: Co-administration of Obeticholic Acid and warfarin may lower the International Normalized Ratio (INR). While taking both drugs, INR should be closely monitored, and warfarin dosage adjusted as necessary to maintain it within the target range.

Narrow Therapeutic Index CYP1A2 Substrates: Obeticholic Acid may increase exposure to concurrent CYP1A2 substrates. For drugs with a limited therapeutic range that are substrates of CYP1A2, therapeutic monitoring is advised.

Contraindications

Obeticholic Acid should not be used by individuals with a known hypersensitivity to the medication or any of its components, or those with complete biliary obstruction.

Pregnancy & Lactation

There's limited human data on the safety of using Obeticholic Acid during pregnancy. It's unclear whether Obeticholic Acid is excreted in human breast milk, its impact on breastfed infants, or its influence on milk production.

Precautions & Warnings

Notable reactions to monitor include severe itching (pruritus) and reductions in low-density lipoprotein-cholesterol (HDL-C). Specialized monitoring is advised for patients experiencing these issues.

Storage Conditions

Store Obeticholic Acid in a dry place protected from light, at temperatures between 15°C to 30°C. Keep it out of reach of children.