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What is Ocaliva?

OCALIVA is a farnesoid X receptor (FXR) agonist. Chemically, obeticholic acid is 3α,7α-dihydroxy-6α-ethyl-5β-cholan-24-oic acid. It is a white to off-white powder. It is soluble in methanol, acetone and ethyl acetate. Its solubility in water is pH dependent. It is slightly soluble at low pH and very soluble at high pH. Its chemical formula is CHO, the molecular weight is 420.63 g/mol and the chemical structure is:

OCALIVA tablets are supplied in 5 mg and 10 mg strengths for oral administration. Each tablet contains obeticholic acid as the active ingredient and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating is Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, and iron oxide yellow.

What does Ocaliva look like?

What are the available doses of Ocaliva?

Tablets: 5 mg, 10 mg ()

What should I talk to my health care provider before I take Ocaliva?

Hepatic Impairment



How should I use Ocaliva?

OCALIVA is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP) . An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Prior to starting OCALIVA in patients with suspected cirrhosis, use the nomogram to calculate Child-Pugh classification (A, B, or C) and determine the appropriate starting dosage.

What interacts with Ocaliva?

Sorry No Records found

What are the warnings of Ocaliva?

Sorry No Records found

What are the precautions of Ocaliva?

Sorry No Records found

What are the side effects of Ocaliva?

Sorry No records found

What should I look out for while using Ocaliva?

OCALIVA is contraindicated in patients with complete biliary obstruction.

What might happen if I take too much Ocaliva?

In PBC patients who received OCALIVA 25 mg once daily (2.5 times the highest recommended dosage) or 50 mg once daily (5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related adverse reactions, including elevations in liver biochemical tests, ascites, jaundice, portal hypertension, and primary biliary cholangitis flare, was reported. Serious liver-related adverse reactions have been reported postmarketing in PBC patients with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly

In the case of overdosage, patients should be carefully observed and supportive care administered, as appropriate.

How should I store and handle Ocaliva?

Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].OCALIVA tablets are packaged in a 40 mL high density polyethylene bottle closed with a 33 mm polypropylene child resistant cap containing an induction seal. Each bottle contains 30 tablets.


Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.

Non-Clinical Toxicology
OCALIVA is contraindicated in patients with complete biliary obstruction.

See Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol has no clinically significant effect on the kinetics of diclofenac or ibuprofen.

Prostaglandins such as misoprostol may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in PBC patients with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly. Reported cases typically occurred within 2 to 5 weeks after starting OCALIVA and were characterized by an acute increase in total bilirubin and/or ALP concentrations in association with clinical signs and symptoms of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, worsening of hepatic encephalopathy). A few cases reported improvement after OCALIVA discontinuation; however, some cases reported ongoing symptoms. Because postmarketing cases often contain limited clinical information, there was insufficient information to rule out confounding factors (e.g., concomitant medications) or the role of the patient's underlying advanced disease in the events

Patients who died due to liver-related complications generally had decompensated cirrhosis prior to treatment and were started on OCALIVA 5 mg once daily, which is 7-fold greater than the once weekly starting regimen in this population .

The following clinically significant adverse reactions are described elsewhere in labeling:



This information is obtained from the National Institute of Health's Standard Packaging Label drug database.

While we update our database periodically, we cannot guarantee it is always updated to the latest version.



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