Pack size: Strip of 10 Tablets  |  Price is for the whole Strip

⚠ Prescription required. This medicine may only be dispensed against a valid prescription.

Generic: Obeticholic Acid

Form: Tablet 5mg

Indication

Primary Biliary Cholangitis Indicated for primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA for at least 1 yr or as monotherapy in adults unable to tolerate UDCA

Administration

May take with or without food Concomitant bile-acid binding resin: Separate obeticholic acid dose by at least 4 hr

Adult Dose

$4b

Contraindication

Complete biliary obstruction

Mode of Action

Farnesoid X receptor (FXR) agonist FXR is a nuclear receptor expressed in the liver, intestine, kidney, and adipose tissue that regulates a wide variety of target genes critically involved in the control of bile acid synthesis and transport, lipid metabolism, and glucose homeostasis FXR activation suppresses de novo synthesis of bile acids in hepatocytes as well as increasing transport of bile acids out of hepatocytes, thereby reducing exposure of the hepatocytes to bile acid

Precaution

Hepatic decompensation and failure, in some cases fatal, reported in patients with PBC who have decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when obeticholic acid was dosed more frequently than the recommended starting dosage of 5 mg once weekly Monitor patients for elevations in liver enzymes and risks for hepatic decompensation (eg, worsening renal function, dehydration) Dose response relationship observed in clinical trials for liver-related adverse reactions, including jaundice, worsening ascites, and primary biliary cholangitis flare (doses >10 mg/day) Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition