EPCLUSA is a fixed dose combination formulation consisting of sofosbuvir and velpatasvir.

1、 Drug name

1. Common name: Ji San Dai

2. Product Name: Epclusa ®

3. Main ingredients: Sofosbuvir and Velpatasvir

2、 Indications

1. Used for treating chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infections in adults.

2. Suitable for patients without cirrhosis or compensated cirrhosis.

3. For patients with decompensated cirrhosis, it is necessary to use it in combination with ribavirin.

3、 Specifications and characteristics

Each tablet contains 400mg of sofosbuvir and 100mg of vapatavir.

4、 Main components

1. Active ingredients: Sofosbuvir and Vepatasvir.

2. Auxiliary materials: copolymer ketone, cross-linked carboxymethyl cellulose sodium, magnesium stearate, microcrystalline cellulose, etc. The coating ingredients include iron oxide red, polyethylene glycol, polyvinyl alcohol, talcum powder, and titanium dioxide.

5、 Usage and dosage

1. The recommended dosage is once a day, one tablet each time, taken orally, and can be taken with food or on an empty stomach.

2. The treatment cycle is usually 12 weeks.

3. Patients without cirrhosis or compensated cirrhosis: use Jisan Dai alone for 12 weeks.

4. Patients with decompensated cirrhosis: Jisanda combined with ribavirin treatment for 12 weeks.

6、 Dose adjustment

1. For patients with severe renal impairment or end-stage renal disease, there is no recommended dosage.

2. Patients with liver function impairment do not need to adjust the dosage.

3. Elderly patients do not need to adjust their dosage.

7、 Medication precautions

1. Can be taken with food or on an empty stomach.

2. If missed, it should be taken as soon as possible, but if it is close to the next medication time, the missed dose should be skipped and medication should be taken according to the original plan. Do not take double the dose at once.

3. If vomiting occurs after taking medication:

(1) Within 4 hours after taking the medication, vomiting occurs and an additional tablet needs to be taken.

(2) Vomiting for more than 4 hours does not require supplementation.

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: It is not yet clear whether it is secreted through breast milk, and the use needs to be balanced between advantages and disadvantages.

3. Children: The safety and efficacy of patients under 18 years old have not been determined.

4. Elderly: No need to adjust dosage.

5. Renal insufficiency: mild to moderate without adjustment; There is no recommended dosage for severe or dialysis patients.

6. Liver dysfunction: No dose adjustment is required for mild, moderate, or severe cases.

9、 Adverse reactions

1. Common adverse reactions include headache and fatigue.

2. When used in combination with ribavirin, common symptoms include fatigue, anemia, nausea, headache, insomnia, and diarrhea.

3. Rare but serious adverse reactions include the possibility of severe bradycardia when combined with amiodarone.

10、 Contraindications

1. Individuals allergic to the ingredients of this product are prohibited from using it.

2. The combination therapy of Jisanda and Ribavirin is contraindicated in patients with contraindications to Ribavirin.

11、 Drug interactions

1. Do not use it in combination with potent P-gp inducers or medium to potent CYP inducers, such as rifampicin, St. John's wort, carbamazepine, etc.

2. Combined use with amiodarone may cause severe bradycardia and is not recommended.

3. When used in combination with certain antacids, H2 receptor antagonists, and proton pump inhibitors, attention should be paid to medication intervals.

4. When used in combination with certain statins, dosage adjustment or close monitoring is necessary.

12、 Storage method

1. Store below 30 ° C.

2. Keep in original packaging, moisture resistant.

3. Please keep out of reach of children.

Epclusainformation