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Sothibuvir and viapatavir tablets (butongsha) (Jisan generation)

This product is used to treat chronic hepatitis C virus (HCV) infection in adults (see [usage and dosage], [precautions] and [pharmacology and toxicology]). More role
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Common name:
Sothibuvir and rapatavir tablets
Product No.:
Approval No.:
H20180024 (inquired by the State Drug Administration)
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Product specification:
Gilead Sciences Ireland UC
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Product name Sothibuvir and viapatavir tablets (butongsha) (Jisan generation)
Main raw materials This product is a compound preparation, and its components are: each tablet contains 400 mg sothibuvir and 100 mg vapatavir.
Main role This product is used to treat chronic hepatitis C virus (HCV) infection in adults (see [usage and dosage], [precautions] and [pharmacology and toxicology]).
Product specification 28s
Usage and dosage The recommended dose of epclusa is one tablet orally once a day, with or without food (see [pharmacokinetics]). See the instructions for details.
manufacturing enterprise Gilead Sciences Ireland UC
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[drug name] Sothibuvir and viapatavir tablets (butongsha) (Jisan generation)

[common name] Sothibuvir and rapatavir tablets

[specification and model] 28s

[manufacturer] Gilead Sciences Ireland UC

[drug type] Western medicine

[approval No.] H20180024

[validity period] 24 months

[functional indications] This product is used to treat chronic hepatitis C virus (HCV) infection in adults (see [usage and dosage], [precautions] and [pharmacology and toxicology]).

[usage and dosage] The recommended dose of epclusa is one tablet orally once a day, with or without food (see [pharmacokinetics]). See the instructions for details.

[adverse reactions] Summary of safety characteristics: The safety assessment of epclusa was based on pooled phase 3 clinical study data from patients with HCV infection (with or without compensated cirrhosis) of genotype 1, 2, 3, 4, 5 or 6, including 1035 patients treated with epclusa for 12 weeks. For patients treated with epclusa for 12 weeks, the proportion of patients who permanently stopped treatment due to adverse events was 0.2%, and the proportion of patients with any serious adverse events was 3.2%. In clinical studies, headache, fatigue and nausea were the most common adverse events (incidence ≥ 10%) reported in patients treated with epclusa for 12 weeks. These and other adverse events were reported at a similar frequency in patients treated with placebo and epclusa. Patients with decompensated cirrhosis: The safety characteristics of epclusa have been evaluated in an open label study in which patients with CPT grade B cirrhosis received 12 weeks of epclusa treatment (n = 90), 12 weeks of epclusa + RBV treatment (n = 87), or 24 weeks of epclusa treatment (n = 90). The adverse events observed in the study were consistent with the expected clinical sequelae of decompensated liver disease or the known toxicity characteristics of ribavirin when patients received epclusa in combination with ribavirin. Of the 87 patients treated with epclusa + RBV for 12 weeks, hemoglobin decreased to less than 10 mg / dl and 8.5 mg / dL in 23% and 7% respectively. 15% of patients receiving 12 weeks of epclusa + RBV stopped ribavirin due to adverse events. Description of selected adverse reactions Arrhythmia Severe bradycardia and heart block were observed when sothibuvir was combined with other direct acting antiviral drugs, amiodarone and / or other drugs to reduce heart rate (see [precautions] and [drug interaction]). Report of suspected adverse reactions Reports of suspected adverse reactions after drugs are approved for marketing are very important. In this way, the benefit / risk balance of the use of the drug can be continuously monitored. In China, healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

[precautions] Warning: risk of hepatitis B virus reactivation in patients with HCV and HBV co infection All patients were tested for signs of current or previous hepatitis B virus (HBV) infection before starting epclusa treatment. HBV reactivation has been reported in HCV / HBV co infected patients who are receiving or have completed HCV direct acting antiviral therapy and who have not received HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, liver failure and death. Patients with HCV / HBV coinfection were monitored for hepatitis attack or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate patient management of HBV infection according to clinical indications. Epclusa should not be administered simultaneously with other drugs containing sothibuvir. See the instructions for details.

[taboo] Hypersensitivity to the active ingredient or any excipient. Strong P-glycoprotein (P-gp) inducers or strong cytochrome P450 (CYP) inducers (rifampicin, rifampicin, Hypericum perforatum, carbamazepine, phenobarbital and phenytoin) were used in combination with strong P-gp inducers and strong CYP inducers. The combination will significantly reduce the plasma concentration of sothibuvir or vapatavir and may lead to the loss of efficacy of epclusa (see [drug interaction]).

[listing Permit Holder] GileadSciencesIrelandUC

[packaging unit] bottle

[main ingredients] This product is a compound preparation, and its components are: each tablet contains 400 mg sothibuvir and 100 mg vapatavir.

[character] This product is a film coated tablet, which turns white to brownish yellow after removing the coating. One side of the film garment is concave engraved with "GSI" and the other side is concave engraved with "7916".

[applicable population] adult

[medication for pregnant and lactating women] Pregnancy: There are no or very limited data on the use of sothibuvir, vapatavir or epclusa in pregnant women (less than 300 pregnancy outcomes). With regard to reproductive toxicity, animal studies have not shown direct or indirect harmful effects (see [pharmacology and toxicology]). Compared with human exposure at the recommended clinical dose, the exposure boundary of sothibuvir in rats cannot be fully estimated (see [pharmacology and toxicology]). Vapatavir: Animal studies have shown that it may be related to reproductive toxicity (see [pharmacology and toxicology]). As a preventive measure, epclusa is not recommended during pregnancy. Lactation: It is unclear whether sothibuvir, a metabolite of sothibuvir, or vapatavir will be secreted into human milk. The pharmacokinetic data obtained from animal experiments showed that the metabolites of vapatavir and sothibuvir were excreted through milk. Risks for newborns / infants cannot be excluded. Therefore, epclusa should not be used during lactation. Fertility: There is no data on the effect of epclusa on human fertility. Animal studies have not shown that sothibuvir or vapatavir have a harmful effect on fertility. If ribavirin is used in combination with epclusa, refer to the prescription information of ribavirin for detailed recommendations on pregnancy, contraception and lactation.

[medication for children] The safety and efficacy of epclusa in children and adolescents under the age of 18 have not been determined. No data available.

[medication for elderly patients] Epclusa's clinical study included 156 patients aged 65 and over (12% of the total number of patients in the phase 3 clinical study). Among the treatment groups, the response rate of patients ≥ 65 years old was similar to that of patients < 65 years old.

[storage] Storage below 30 ° C

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