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Ocaliva
obeticholic acid
Black Box Warnings .
Hepatic Decompensation and Failure
hepatic decompensation and failure, some fatal or resulting in liver transplant, reported in pts treated w/ obeticholic acid w/ or w/o compensated or decompensated cirrhosis; contraindicated in pts w/ decompensated cirrhosis, prior decompensation event, or compensated cirrhosis w/ evidence of portal HTN; permanently D/C in pts who develop hepatic decompensation, evidence of portal HTN w/ compensated cirrhosis, or clinically significant hepatic adverse rxns
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg
Restricted Distribution in US
- [1-844-622-4278 or www.ocaliva.com for more info]
primary biliary cholangitis
- [5-10 mg PO qd]
- Start: 5 mg PO qd x3mo, then may incr. to 10 mg PO qd if needed; Max: 10 mg/day; Info: for pts w/o cirrhosis or w/ compensated cirrhosis w/o evidence of portal HTN; may give w/ ursodiol; see pkg insert for severe pruritus management recommendations
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C, decompensated cirrhosis, prior decompensation event, or compensated cirrhosis w/ evidence of portal HTN: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.