SOVALDI ACCESS- sofosbuvir tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

SOFOSBUVIR (UNII: WJ6CA3ZU8B) (SOFOSBUVIR - UNII:WJ6CA3ZU8B)

MAH:

Gilead Sciences, Inc.

INN:

SOFOSBUVIR

composition:

SOFOSBUVIR 400 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2), and Clinical Studies (14)] - genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin - genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. Pediatric Patients: SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see Dosage and Administration (2.3) and Clinical Studies (14.5)] . When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavi

leaflet_short:

SOVALDI tablets are white, capsule-shaped, film-coated tablets containing 400 mg sofosbuvir debossed with "GSI" on one side and "7977" on the other side. Each bottle contains 28 tablets, a silica gel desiccant and polyester coil with a child-resistant closure. Store below 30°C (86°F).

authorization_status:

Export only

SPC

SOVALDI ACCESS- SOFOSBUVIR TABLET, FILM COATED
GILEAD SCIENCES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOVALDI SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SOVALDI.
GILEAD ACCESS PROGRAM
SOVALDI™ (SOFOSBUVIR) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED
WITH HCV
AND HBV
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATITIS B VIRUS (HBV) REACTIVATION HAS BEEN REPORTED, IN SOME CASES
RESULTING IN FULMINANT HEPATITIS,
HEPATIC FAILURE, AND DEATH. ( 5.1)
INDICATIONS AND USAGE
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase
inhibitor indicated for the treatment of:
Adult patients with genotype 1, 2, 3 or 4 chronic hepatitis C virus
(HCV) infection without cirrhosis or with compensated
cirrhosis as a component of a combination antiviral treatment regimen.
( 1)
Pediatric patients 12 years of age and older or weighing at least 35
kg with genotype 2 or 3 chronic HCV infection
without cirrhosis or with compensated cirrhosis in combination with
ribavirin. ( 1)
DOSAGE AND ADMINISTRATION
Testing Prior to the Initiation of Therapy: Test all patients for HBV
infection by measuring HBsAg and anti-HBc. ( 2.1)
Recommended adult and pediatric dosage: One 400 mg tablet taken once
daily with or without food. ( 2.2, 2.3)
HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1
coinfection, follow the dosage
recommendations in the tables below, respectively. ( 2.2, 2.3)
Recommended adult treatment regimen and duration: ( 2.2)
ADULT PATIENT POPULATION
REGIMEN AND DURATION
Genotype 1
or 4
Treatment-naïve without cirrhosis or with compensated cirrhosis
(Child-Pugh A)
SOVALDI + peginterferon alfa +
ribavirin
12 weeks
Genotype 2
Treatment-naïve and treatment-experienced without cirrhosis or with
compensated cirrhosis
(Child-Pugh A)
SOVALDI + ribavirin
12 weeks
Genotype 3
Treatment-naïve and treatment-experienced