Generic Name and Formulations:
Obeticholic acid 5mg, 10mg; tabs.
Company:
Intercept Pharmaceuticals
Indications for OCALIVA:
Treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

Adult:
Initially 5mg once daily. Increase to 10mg once daily if inadequate reduction in ALP and/or total bilirubin after 3 months and tolerated the drug; max 10mg once daily. Moderate or severe hepatic impairment: initially 5mg once weekly; increase to 5mg twice weekly (≥3 days apart) then to 10mg twice weekly (≥3 days apart) if inadequate reduction in ALP and/or total bilirubin after 3 months and tolerated the drug. Intolerable pruritus: consider adding an antihistamine or bile acid binding resin; or reducing dose to 5mg every other day (if intolerant to 5mg daily) or 5mg once daily (if intolerant to 10mg daily); or temporarily interrupt for up to 2 weeks then restart at lower dose. Increase dose to 10mg once daily as tolerated for optimal response.

Children:
Not established.

Contraindications:
Complete biliary obstruction.

Warnings/Precautions:
Discontinue if intolerable pruritus persists or complete biliary obstruction develops. Monitor for elevations in liver biochemical tests and liver-related adverse effects. Monitor for changes in serum lipid levels. If unresponsive after 1 year of treatment at max tolerable dose (10mg once daily) and experienced HDL-C reduction, reeva luate. Pregnancy. Nursing mothers.

Interactions:
Separate dosing by ≥4hrs or at greatest possible interval with bile acid binding resins (eg, cholestyramine, colestipol, colesevelam). Concomitant warfarin: monitor INR and adjust dose as needed. Concomitant CYP1A2 substrates with narrow therapeutic index (eg, theophylline, tizanidine); monitor.

Pharmacological Class:
Farnesoid X receptor (FXR) agonist.

Adverse Reactions:
Pruritus, fatigue, abdominal pain/discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, eczema; liver-related effects, HDL-C reduction.

Generic Availability:
NO

How Supplied:
Tabs—30