Epclusa Tablets

Adult dose

Treatment-naive and treatment-experienced patientsa without cirrhosis or with compensated cirrhosis (Child-Pugh A): this drug for 12 weeks Treatment-naive and treatment-experienced patientsa with decompensated cirrhosis (Child-Pugh B or C): this drug + ribavirinb for 12 weeks a. In clinical trials in adults, the regimen included peginterferon alfa/ribavirin, with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). b. Refer to Dosage and Administration for ribavirin dosage recommendations. If vomiting occurs within 3 hours of taking the drug, instruct the patient to take an additional tablet. If vomiting occurs more than 3 hours after administration, no additional dose is needed. If a dose is missed and it is within 18 hours of the usual dosing time, instruct the patient to take the tablet as soon as possible. The patient should then take the next dose at the usual time. If more than 18 hours have passed, instruct the patient to wait and take the next dose at the usual time. Instruct the patient not to take a double dose. Instruct the patient to swallow the film-coated tablet whole, with or without food. Because of its bitter taste, the film-coated tablet should preferably not be chewed or crushed. The recommended dose of this drug in adults is 1 tablet (sofosbuvir 400 mg and velpatasvir 100 mg) orally once daily, with or without food. When administered with this drug, the recommended dose of ribavirin is weight-based (administered with food): 1,000 mg daily for patients weighing less than 75 kg and 1,200 mg daily for patients weighing 75 kg or more, divided into 2 doses. The initial ribavirin dose and the dose during treatment may be reduced based on hemoglobin and creatinine clearance. Refer to the ribavirin prescribing information for dose adjustment. No dose adjustment of this drug is necessary regardless of the degree of renal impairment, including in patients requiring dialysis. Administer this drug with or without ribavirin according to the recommendations in Table 1. For ribavirin dose adjustment in patients with creatinine clearance (CrCl) of 50 mL/min or less, refer to the ribavirin prescribing information.

Child dose

The recommended dose of this drug for pediatric patients aged 12 years and older and weighing at least 30 kg is 1 tablet (sofosbuvir 400 mg and velpatasvir 100 mg) orally once daily, with or without food. 30-47 kg: 15 mg/kg per day (divided doses in the morning and afternoon) 47–49 kg: 600 mg per day (1 x 200 mg in the morning, 2 x 200 mg in the afternoon) 50–65 kg: 800 mg per day (2 x 200 mg in the morning, 2 x 200 mg in the afternoon) 66–80 kg: 1,000 mg per day (2 x 200 mg in the morning, 3 x 200 mg in the afternoon) Over 80 kg: 1,200 mg per day (3 x 200 mg in the morning, 3 x 200 mg in the afternoon) a. The daily dose of ribavirin is weight-based and administered orally in 2 divided doses with food.

This medication may pose a risk of reactivation of hepatitis B virus in patients simultaneously infected with hepatitis B virus. Prior to starting treatment, patients must be tested for hepatitis B virus infection and liver status should be periodically monitored during and after treatment. Co-administration with amiodarone, a specific heart medication, may cause very slow heart rates, and this combination is not recommended. If it must be taken together, close monitoring of heart conditions from the beginning of co-administration is required. This medication, when used with ribavirin, should not be administered to pregnant women or women capable of becoming pregnant and their partners. Additionally, patients allergic to any component of this medication should not receive it. During treatment with this medication, symptoms such as headache, fatigue, nausea, insomnia, etc., may commonly occur, and in severe cases, treatment may need to be discontinued. When used in combination with other medications, the effectiveness of this medication may be reduced, or side effects may increase, so it is essential to consult a physician or pharmacist about any current medications being taken. Special caution is needed in patients with impaired liver or kidney function, elderly patients, and children, and dosage adjustments or additional tests may be necessary. Careful consideration and consultation with a physician are needed for administration in pregnant or nursing women. In the event of an overdose, since there is no specific antidote, it is essential to visit a medical institution immediately for appropriate treatment. This medication should be stored away from direct sunlight at a temperature of 1 to 30 degrees Celsius and kept in a safe place out of reach of children.

• HBV reactivation
• fulminant hepatitis
• liver failure
• death
• symptomatic bradycardia
• pre-syncope
• syncope
• dizziness
• vertigo
• malaise

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy and safety of the medication for an extended period.

Appearance

Pink diamond-shaped film-coated tablet with 'GSI' on one side and '7916' on the other side.

Package unit

28 tablets / bottle