• Digestive and biliary disorders

Ocaliva Generic Name & Formulations

General Description

Obeticholic acid 5mg, 10mg; tabs.

Pharmacological Class

Farnesoid X receptor (FXR) agonist.

How Supplied


Generic Availability


Ocaliva Indications


Primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis without evidence of portal hypertension, in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

Ocaliva Dosage and Administration


Initially 5mg once daily; may increase to max 10mg once daily if inadequate reduction in ALP and/or total bilirubin after 3 months and tolerated the drug. Management of intolerable pruritus: consider adding an antihistamine or bile acid binding resin; reduce dose and/or temporarily interrupt for up to 2 weeks; see full labeling.


Not established.

Ocaliva Contraindications


Decompensated cirrhosis (eg, Child-Pugh Class B or C) or prior decompensation event. Compensated cirrhosis with evidence of portal hypertension (eg, ascites, gastroesophageal varices, persistent thrombocytopenia). Complete biliary obstruction.

Ocaliva Boxed Warnings

Boxed Warning

Hepatic decompensation and failure in PBC patients with cirrhosis.

Ocaliva Warnings/Precautions


Risk of hepatic decompensation and failure in PBC patients with either compensated or decompensated cirrhosis. Monitor closely for new evidence of portal hypertension or increases in total bilirubin, direct bilirubin, and prothrombin time above ULN in those with compensated cirrhosis, concomitant hepatic disease (eg, autoimmune hepatitis, alcoholic liver disease), and/or severe intercurrent illness. Permanently discontinue in patients who develop evidence (lab or clinical) of hepatic decompensation (eg, ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension, experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. Interrupt and monitor liver function if severe intercurrent illness occurs; consider restarting after resolution. Consider evaluation of those with new onset or worsening severe pruritus. Consider discontinuing if intolerable pruritus persists despite management strategies. Monitor for changes in serum lipid levels. Reevaluate if unresponsive after 1 year at max tolerable dose (10mg once daily) and experienced HDL-C reduction. Pregnancy. Nursing mothers.

Ocaliva Pharmacokinetics

See Literature

Ocaliva Interactions


Avoid concomitant bile salt efflux pump (BSEP) inhibitors (eg, cyclosporine); if co-administration necessary, monitor LFTs. Separate dosing by ≥4hrs or at greatest possible interval with bile acid binding resins (eg, cholestyramine, colestipol, colesevelam). Monitor INR and adjust dose as needed when concomitant warfarin. Concomitant CYP1A2 substrates with narrow therapeutic index (eg, theophylline, tizanidine); monitor.

Ocaliva Adverse Reactions

Adverse Reactions

Pruritus (may be severe), fatigue, abdominal pain/discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, eczema; liver-related effects, HDL-C reduction.

Ocaliva Clinical Trials

See Literature

Ocaliva Note

Not Applicable

Ocaliva Patient Counseling

See Literature