Digestive and biliary disorders:
Indications for: OCALIVA
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.
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.
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.
Hepatic decompensation and failure in PBC patients with cirrhosis.
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.
Farnesoid X receptor (FXR) agonist.
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.
Pruritus (may be severe), fatigue, abdominal pain/discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, eczema; liver-related effects, HDL-C reduction.
Generic Drug Availability: