HIGHLIGHTS OF PRESCRIBING INFORMATION （的处方信息）.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION Treatment-naïve and treatment- Genotype HARVONI These highlights do not include all the information needed to use experienced without cirrhosis or with HARVONI® safely and effectively. See full prescribing information 4, 5, or 6 compensated cirrhosis (Child-Pugh A) 12 weeks for HARVONI. • Recommended treatment duration for pediatric patients 12 years of HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use age and older or weighing at least 35 kg (2.3) Initial U.S. Approval: 2014 Pediatric Patient Population 12 Regimen Years of Age and Older or and WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN Weighing at Least 35 Kg Duration PATIENTS COINFECTED WITH HCV AND HBV Treatment-naïve without cirrhosis HARVONI See full prescribing information for complete boxed warning. or with compensated cirrhosis 12 weeks