Direct Healthcare Professional Communication (DHPC) on Ocaliva®▼ (obeticholic acid): New contraindication for treatment of primary biliary cholangitis (PBC) in decompensated cirrhosis or history of hepatic decompensation.
2022.06.09
Active substance: obeticholic acid
Intercept Pharma International Ltd., in consultation with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), informs that the use of obeticholic acid is now contraindicated in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis (including Child-Pugh class B or C) or a previous decompensation event. Treatment must be discontinued in patients with PBC with decompensated cirrhosis who are currently receiving obeticholic acid.
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