Date: 3 March 2016

Description:

Postmarketing reports have been received of hepatic decompensation and hepatic failure in patients treated with Viekirax® with Exviera®, including cases involving liver transplantation or fatal outcomes. Most of the patients with severe outcomes had evidence of advanced or decompensated cirrhosis prior to starting the treatment. The product information will be updated with new safety information that the use of Viekirax® with or without Exviera® is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients receiving Viekirax® and Exviera® should be counselled to watch for early symptoms of liver injury, and monitored for signs of hepatic problems. Please refer to the Direct Healthcare Professional Communication (DHPC) issued by AbbVie Sdn. Bhd. for further information.