Danoprevir Sodium Tablets was approved for marketing by the National Medical Products Administration (NMPA) in June 2018, and it is China’s first indigenously developed oral anti-hepatitis C virus (HCV) Class 1 innovative drug.
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Privacy Danoprevir Sodium Tablets (Trade Name: Genovir) is a domestic Class 1 innovative direct-acting antiviral agent (DAA) against hepatitis C virus (HCV), developed by Ascletis Pharmaceuticals (Zhejiang) Co., Ltd., and it is a next-generation HCV NS3/4A protease inhibitor.
Danoprevir Sodium Tablets, in combination with Ritonavir, Pegylated Interferon Alfa and Ribavirin, is indicated for adult patients with treatment-naive, non-cirrhotic chronic HCV genotype 1b infection.
Danoprevir Sodium Tablets are for oral administration, which may be taken on an empty stomach or with food.
Dosage of Danoprevir Sodium Tablets: 100mg twice daily for 12 consecutive weeks. Ritonavir (a pharmacokinetic booster), pegylated interferon alfa and ribavirin must be co-administered with this product.
Recommended dosage of Ritonavir Tablets (RTV): For oral administration, 100mg twice daily for 12 consecutive weeks (see the package insert for Ritonavir Tablets for details).
Recommended dosage of Pegylated Interferon Alfa (PEG-IFNα): 180μg via subcutaneous injection once weekly for 12 consecutive weeks (see the package insert for Pegylated Interferon Alfa Injection for details).
Recommended dosage of Ribavirin: For oral administration, 1000mg daily (for body weight < 75 kg) or 1200mg daily (for body weight ≥ 75 kg), in two divided doses, for 12 consecutive weeks (see the package insert for Ribavirin preparations for details).
Danoprevir Sodium Tablets are contraindicated in patients with a previous hypersensitivity to this product or any of its ingredients.
For contraindications related to the concomitant use of Danoprevir Sodium Tablets with other medications, refer to the package inserts of the respective medications.
Asthenia, headache, fever and fatigue are the most common manifestations, mostly mild to moderate in severity. These symptoms usually resolve gradually with the progression of treatment and are without obvious dose dependence.
Mild nausea, diarrhea, abdominal pain and vomiting may occur, with dry mouth and anorexia rarely observed. Discontinuation of the drug is generally not required, and the symptoms can be relieved with symptomatic treatment.
Decreased neutrophil count and mild reduction in platelet count may be seen. These reactions are mostly associated with the concomitant use of pegylated interferon alfa and ribavirin. Danoprevir Sodium Tablets itself has no significant toxicity to the hematopoietic system, and hematological parameters return to normal after drug withdrawal.
A small number of patients may have mild elevation of transaminases (ALT/AST), which are transient reactions. There are no clinical reports of severe liver function damage associated with this, and such reactions are linked to the immune response during hepatitis C virus (HCV) clearance.
Pregnancy
No data are available on the use of this product in pregnant women.
Lactating Women
It is unknown whether any components of this product or their metabolites are excreted into human milk. Use with caution in lactating women.
No clinical data on the safety and efficacy of this product in pediatric patients are available.
No clinical data on the safety and efficacy of this product in geriatric patients are available.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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