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...
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