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Obeticholic acid

Class
Cholelitholytics
Subclass
Semisynthetic bile acids
Generic name
Obeticholic acid
Brand names
Ocaliva®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Treatment of primary biliary cholangitis
•
5-10 mg PO daily
Indications for use
Labeled indications
Adults
•
Treatment of primary biliary cholangitis
Safety risks
Boxed warnings
ALF, decompensated liver disease
ALF, decompensated liver disease, portal hypertension
•
Use extreme caution in primary biliary cholangitis patients with either compensated or decompensated cirrhosis.
Contraindications
Compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)
Complete biliary obstruction
Decompensated cirrhosis (Child-Pugh Class B or C) or a prior decompensation event
Warnings and precautions
Generalized pruritus, decreased serum HDL
•
Maintain a high level of suspicion, as obeticholic acid has been associated with an increased risk for these adverse events.
Specific populations
Renal impairment
eGFR ≥ 15 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 15 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Acute or decompensated chronic liver disease
•
Do not use.
Child-Pugh A (mild)
•
Use with caution.
Child-Pugh B (moderate)
•
Do not use.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if benefits outweigh potential risks.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Fatigue, generalized pruritus
Common 1-10%
•
Eczema, peripheral edema, arthralgia, constipation, dizziness, fever, palpitations, skin rash, throat pain, thyroid disease
Unknown frequency
•
Acute liver failure, ascites, death, ↓ serum HDL, jaundice, liver cirrhosis, primary biliary cholangitis, abdominal discomfort, abdominal pain
Interactions
Drug(s)
Check Interactions
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