Ocaliva

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.