Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SOFOSBUVIR (UNII: WJ6CA3ZU8B) (SOFOSBUVIR - UNII:WJ6CA3ZU8B)
Gilead Sciences, Inc.
SOFOSBUVIR
SOFOSBUVIR 400 mg
ORAL
PRESCRIPTION DRUG
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
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).
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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 Lire le document complet