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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 patients treated with obeticholic acid with or without compensated or decompensated cirrhosis; contraindicated in patients with decompensated cirrhosis, prior decompensation event, or compensated cirrhosis with evidence of portal HTN; permanently D/C in patients who develop hepatic decompensation, evidence of portal HTN with compensated cirrhosis, or clinically significant hepatic adverse reactions
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg
Withdrawn from US Market
- [November 14, 2025]
- Info: voluntarily withdrawn due to reported serious hepatic injury cases and risk/benefit profile; 1-844-782-4278 or www.interceptmedinfo.com/medical-information-requests/ for more info
Peds Dosing .
- Dosage forms: --
Withdrawn from US Market
- [November 14, 2025]
- Info: voluntarily withdrawn due to reported serious hepatic injury cases and risk/benefit profile; 1-844-782-4278 or www.interceptmedinfo.com/medical-information-requests/ for more info
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class B-C
- cirrhosis, decompensated
- hepatic decompensation event history
- compensated cirrhosis with evidence of portal HTN
- biliary obstruction, complete
- caution: hepatic disease, concurrent
- caution: intercurrent illness, severe
Drug Interactions .
Overview
obeticholic acid
farnesoid X agonist
- BSEP substrate
- CYP1A2 inhibitor, weak
- binds to anion exchange resin/polymer
- Withdrawn from US Market
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 function abnormalities
- eczema
Safety/Monitoring .
Monitoring Parameters
LFTs, signs/symptoms of 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: for obeticholic acid: liver; CYP450: none; Info: enterohepatically recirculated; active metabolites
Excretion: for obeticholic acid: feces 87%, urine <3%; Half-life: 24h
Subclass: Hepatobiliary
Mechanism of Action
for obeticholic acid: agonizes farnesoid X receptor, decreasing intracellular hepatocyte concentrations of bile acids
Formulary .
No Formulary Selected
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