INDICATIONS AND USAGE（适应症）

EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection:

without cirrhosis or with compensated cirrhosis

with decompensated cirrhosis for use in combination with ribavirin.

DOSAGE（服用剂量）

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with EPCLUSA.

Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older

The recommended treatment regimen and duration based on patient population.

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations. For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the recommended regimen is EPCLUSA once daily for 12 weeks. Refer to Drug Interactions for dosage recommendations for concomitant drugs.

Recommended Dosage in Adults

The recommended dosage of EPCLUSA in adults is one tablet (400 mg sofosbuvir and 100 mg velpatasvir) taken orally once daily with or without food.

When administered with EPCLUSA, the recommended dosage of ribavirin is based on weight (administered with food): 1,000 mg per day for patients less than 75 kg and 1,200 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on-treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance. For ribavirin dosage modifications refer to the ribavirin prescribing information.

Recommended Dosage in Pediatric Patients 3 Years of Age and Older

The recommended dosage of EPCLUSA in pediatric patients 3 years of age and older is based on weight. The weight-based dosage of ribavirin when used in combination with EPCLUSA for pediatric patients. Take EPCLUSA oral pellets or tablets once daily with or without food. In pediatric patients less than 6 years of age, administer the oral pellets with food to increase tolerability related to palatability.

ADVERSE REACTIONS（不良反应）

Serious Symptomatic Bradycardia When Coadministered with Amiodarone

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/7f30631a-ee3b-4cfe-866b-964df3f0a44f/spl-doc?hl=Epclusa

velpanexinformation