Viekirax® (ombitasvir/ paritaprevir/ ritonavir) with or without Exviera® (dasabuvir): Not recommended in Child-Pugh B Patients

User Rating: 2 / 5

Star ActiveStar ActiveStar InactiveStar InactiveStar Inactive
 

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.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

Image   Image   Image   Image  

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Wednesday 27 March 2024, 22:44:22.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Main Menu English