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All Names： Epclusa、吉三代、丙通沙、伊柯鲁沙、索磷布韦维帕他韦片、索非布韦维帕他韦片
Indications：Suitable for adult and pediatric patients aged 3 years and above, including patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis, accompanied by compensated cirrhosis (Child Pugh A grade, can be used alone), accompanied by decompensated cirrhosis (Child Pugh B/C grade, requiring combination with ribavirin), as well as liver transplant recipients with HCV/HIV-1 co infection, without cirrhosis or accompanied by compensated cirrhosis, patients with severe renal dysfunction requiring dialysis, and injection drug users.
Manufacturer：Daxiong
Customs Clearance Procedure：If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
EPCLUSA is a fixed dose combination formulation consisting of sofosbuvir and velpatasvir.
1、 Drug name
1. Common name: EPCLUSA ®)
2. Product Name: Sofosbuvir, Vepatasvir Tablets
2、 Indications
Used for treating chronic hepatitis C virus (HCV) gene type 1, 2, 3, 4, 5, or 6 infections in adults:
1. Used alone for patients without cirrhosis or compensated cirrhosis.
2. Patients with decompensated cirrhosis need to use ribavirin in combination.
3、 Specifications and characteristics
Each tablet contains 400mg of sofosbuvir and 100mg of vapatavir.
4、 Main components
Active ingredients: Sofosbuvir and Vepatasvir.
5、 Usage and dosage
1. Recommended dosage: Take one tablet orally once a day, which can be taken with food or on an empty stomach.
2. Treatment plan:
(1) Patients without cirrhosis or compensated cirrhosis: EPCLUSA monotherapy for 12 weeks.
(2) Patients with decompensated cirrhosis: EPCLUSA combined with ribavirin treatment for 12 weeks.
6、 Dose adjustment
1. There is no recommended dosage for patients with severe renal impairment.
2. When used in combination with ribavirin, the dosage of ribavirin should be adjusted based on hemoglobin and creatinine clearance rates.
7、 Medication precautions
1. Take antacids with a 4-hour interval.
2. Handling of missed doses: It is recommended to take medication regularly and not miss or skip doses.
3. If vomiting occurs after taking medication, it is necessary to consult medical professionals.
8、 Medication for special populations
1. Pregnant women: If used in combination with ribavirin, it is contraindicated for pregnant women and male partners who are pregnant.
2. Breastfeeding period: Safety is unknown, and the pros and cons need to be weighed.
3. Children: Safety and effectiveness have not been established.
4. Elderly: No need to adjust dosage.
5. Renal insufficiency: Mild to moderate without adjustment, severe without recommended dosage.
6. Liver dysfunction: No dose adjustment is required for mild, moderate, or severe cases.
9、 Adverse reactions
Common adverse reactions (incidence ≥ 10%):
1. EPCLUSA monotherapy: headache, fatigue.
2. EPCLUSA+Ribavirin: fatigue, anemia, nausea, headache, insomnia, diarrhea.
10、 Contraindications
The combination therapy of EPCLUSA and ribavirin is contraindicated in patients with contraindications to ribavirin.
11、 Drug interactions
1. Do not use in combination with amiodarone (which may cause severe symptomatic bradycardia).
2. Avoid combination therapy with P-gp inducers and medium to potent CYP inducers (such as rifampicin, St. John's wort, carbamazepine).
3. When used in combination with rosuvastatin, the dose of rosuvastatin should not exceed 10mg.
12、 Storage method
1. Storage temperature: below 30 ℃.
2. Keep the original packaging.
3. Do not use if the seal is damaged.
13、 Important Warning
Patients using amiodarone in combination with EPCLUSA may experience severe symptomatic bradycardia, and electrocardiographic monitoring is recommended.
Epclusainformation
