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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.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class B-C
- cirrhosis, decompensated
- hepatic decompensation event hx
- compensated cirrhosis w/ evidence of portal HTN
- biliary obstruction, complete
- caution: hepatic dz, concurrent
- caution: intercurrent illness, severe
Drug Interactions .
Overview
obeticholic acid
farnesoid X agonist
- BSEP substrate
- CYP1A2 inhibitor, weak
- binds to anion exchange resin/polymer
Contraindicated
- fezolinetant
Avoid/Use Alternative
- cyclosporine
- tizanidine
Monitor/Modify Tx
- aminophylline
- bendamustine
- caffeine citrate
- cholestyramine
- clozapine
- colesevelam
- colestipol
- theophylline
- warfarin
Caution Advised
- alosetron
- pirfenidone
- roflumilast
- roflumilast topical
- vorasidenib
Adverse Reactions .
Serious Reactions
- hepatic failure
- hepatotoxicity
- hepatic decompensation
- hepatic encephalopathy
- ascites
Common Reactions
- pruritus
- fatigue
- HDL-C decr.
- abdominal discomfort
- abdominal pain
- rash
- arthralgia
- oropharyngeal pain
- dizziness
- constipation
- peripheral edema
- palpitations
- fever
- thyroid fxn abnormalities
- eczema
Safety/Monitoring .
Monitoring Parameters
LFTs, s/sx hepatic injury frequently; lipid panel
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; no known risk of fetal harm based on animal data up to 13x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: none; Info: enterohepatically recirculated; active metabolites
Excretion: feces 87%, urine <3%; Half-life: 24h
Subclass: Hepatobiliary
Mechanism of Action
agonizes farnesoid X receptor, decreasing intracellular hepatocyte concentrations of bile acids
Formulary .
No Formulary Selected
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