Indications: Ocaliva (Obeticholic Acid) is indicated for the treatment of primary biliary cholangitis (PBC), also known as primary biliary cirrhosis, in adult patients:

• In combination with ursodeoxycholic acid (UDCA) in adults who have not responded adequately to UDCA.
• As monotherapy in adults who are unable to tolerate UDCA.

Dosage and Administration: The recommended starting dose is 5 mg orally once daily for the first 3 months. After 3 months, if there has not been an adequate biochemical response and the patient is tolerating the medication, the dosage may be increased to 10 mg once daily. Ocaliva can be taken with or without food. For patients taking bile acid binding resins, Ocaliva should be taken at least 4 hours before or after taking these medications. The dosage may be adjusted by the physician based on the patient's response and tolerability.

Side Effects: Very common side effects include pruritus (itching) and fatigue. Common side effects may include abdominal pain or discomfort, rash, arthralgia (joint pain), oropharyngeal pain (pain in the mouth and throat), dizziness, constipation, and peripheral edema (swelling in the hands, ankles, or feet).

Precautions: Ocaliva is contraindicated in patients with decompensated cirrhosis, compensated cirrhosis with evidence of portal hypertension, complete biliary obstruction, and known hypersensitivity to obeticholic acid or any of the excipients. Caution should be exercised in patients with a history of severe pruritus and in patients with moderate to severe hepatic impairment. Monitor liver function tests and lipid levels during treatment.

Use in Pregnancy and Lactation: There are limited data on the use of obeticholic acid in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whetherobeticholic acid is excreted in human milk. Caution should be exercised when administering Ocaliva to a nursing woman.

Storage: Store as directed by the manufacturer, usually at room temperature, away from moisture and heat. Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.