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SOFOXEN (Sofosbuvir INN 400 mg)
Therapeutic Class: Hepatology
Pack Size: Each HDPE bottle of SOFOXEN contains 7/28 tablets (each tablet contains Sofosbuvir INN 400 mg), a silica gel desiccant and polyester coil with a child-resistant closure.

INDICATIONS AND USAGE


Adult Patients
SOFOXEN is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.

  • genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and Ribavirin, or with Direct-acting Antivirals (DAAS)
  • genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with Ribavirin or with Direct-acting Antivirals (DAAs).
     

Pediatric Patients
SOFOXEN 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.