30 Tab Obeticholic Acid 5mg Primary Biliary Cholangitis Ocabile 5 Mg Tablet

【[Drug Name]

Generic Name: Obeticholic Acid

English name: Obeticholic acid

Trade name: Obetan

Indications
Obetan is a farnesol X receptor (FXR) agonist. Obetan is used in combination with ursodeoxycholic acid (UDCA) in adult patients with primary biliary cholangitis (formerly known as primary biliary cirrhosis (PBC)) who do not respond adequately to UDCA, or as monotherapy in adult patients with primary biliary cholangitis who are intolerant to UDCA.

[Dosage and method of administration
Method of administration

Starting Dose: The recommended starting dose of olabetan in adult patients who have had an inadequate response to 1 year of UDCA therapy or in adult patients intolerant to UDCA is 5 mg orally once a day.

Dose Titration: If, after 3 months of treatment with olabetan 5 mg daily, the patient's ALP decreases and/or serum total bilirubin does not reach the standard, and the patient is tolerant to olabetan, increase the dose to 10 mg once daily.

Maximum dose: 10 mg once daily.

Management Strategies for Patients Who Cannot Tolerate Pruritus: See full prescribing information.

Hepatic Impairment: See full prescribing information for patients with moderate or severe hepatic impairment.

Dosage Form Specifications

Tablets, 5mg, 10mg.

Contraindications

Obetane is not indicated in patients with complete biliary obstruction.

[Warnings and Precautions
Liver-related adverse reactions

Monitor liver biochemistry and the development of liver-related adverse reactions; weigh the benefits and potential risks of continued therapy. Do not exceed 10 mg once a day; dose should be adjusted in patients with moderate or severe hepatic impairment. Discontinue in patients with complete biliary obstruction.

Severe pruritus:

Management strategies include the addition of bile acid binding resins or antihistamines; dose reduction and/or temporary interruption of olbertan.

Decreased HDL-C:

Monitor for changes in lipid levels during treatment.

Adverse Reactions
Most common adverse reactions (≥5%): pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid dysfunction, eczema.

Storage
Store at 20°C-25°C (68°F-77°F), storage at 15°C- to 30°C is also permitted.