Roche Pharma AG in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices would like to inform you that severe cases of drug-induced liver injury (DILI) with Esbriet (pirfenidone), including cases with fatal outcome have recently been reported. Liver function tests (ALT, AST, bilirubin) should be performed before starting treatment with Esbriet (pirfenidone), subsequently every month for the first 6 months and then every 3 months for the duration of treatment.