lunes, 13 de noviembre de 2017

OLYSIO, DAKLINZA and ZEPATIER Labels Were Updated

U.S. Food and Drug Administration Header

OLYSIO (simeprevir), DAKLINZA (daclatasvir) and ZEPATIER (grazoprevir/elbasvir) labels were updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.

Section 7: DRUG INTERACTIONS was updated to state fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment. Frequent monitoring of INR values is recommended during treatment and post-treatment follow-up.
 
The updated label will soon be available at drugs@fda or DailyMed

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Visit the FDA Patient Network for more Information about the Hepatitis Liaison Program 

No hay comentarios:

Publicar un comentario