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Liver drug with liver toxicity? Not the best combination

By Brian Orelli
Staff Writer

Monday, October 2, 2017

It's been a rough couple of weeks for Intercept Pharmaceuticals Inc. In the middle of September, Intercept issued a Dear Healthcare Provider letter stressing the importance of proper dosing of its primary biliary cholangitis (PBC) treatment, Ocaliva (obeticholic acid), in patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis) who are supposed to take 5 mg of Ocaliva once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. Instead, some doctors were giving the dose for patients with no or mild hepatic impairment (noncirrhotic or Child-Pugh A cirrhosis), which starts at 5 mg once daily – seven times the dose for patients with moderate or severe hepatic impairment.

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