Lucisof 400 (SOVALDI)is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:
1.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.
2. 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
DOSAGE AND ADMINISTRATION
1.Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
2.Recommended adult and pediatric dosage: One 400 mg tablet taken once daily with or without food.
3.HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables below, respectively. 4.Recommended adult treatment regimen and duration:
Adult Patient Population Regimen and Duration
(1) Genotype 1 or 4
Adult Patient Population: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Regimen and Duration: SOVALDI + peginterferon alfa + ribavirin 12 weeks
(2) Genotype 2
Adult Patient Population: Treatment-naïve and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Regimen and Duration: SOVALDI + ribavirin 12 weeks
(3) Genotype 3
Adult Patient Population: Treatment-naïve and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Regimen and Duration: SOVALDI + ribavirin 24 weeks
5. SOVALDI (Lucisof 400) in combination with ribavirin for 24 weeks can be considered for adult patients with genotype 1 infection who are interferon ineligible.
6. Should be used in combination with ribavirin for treatment of HCV in adult patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first.
7. Recommended treatment regimen and duration for pediatric patients 12 years of age and older or weighing at least 35 kg:
(1) Genotype 2
Pediatric Patient Population 12 Years of Age and Older or Weighing at Least 35 kg: Treatment-naïve and treatment experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Regimen and Duration: SOVALDI + ribavirin 12 weeks
(2) Genotype 3
Pediatric Patient Population 12 Years of Age and Older or Weighing at Least 35 kg: Treatment-naïve and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Regimen and Duration: SOVALDI + ribavirin 24 weeks
8. A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease
Lucisof 400’s brand name is rx786.com Lucisof 400 is a generic oncologic prescription medicine from Lucius pharmaceutical, which is one of the biggest pharmaceutical company in India.
For more Prescribing information，please check the → “FDA Prescribing Information”.
89.00 per 28 Tablets
