Ganovo Danoprevir Sodium Tablets

1. Indications and Usage
Treatment of Chronic Hepatitis C Virus (HCV) Infection:
Indicated for the treatment of treatment-naïve adult patients with non-cirrhotic chronic hepatitis C virus genotype 1b infection.
Combination Therapy:
Must be used in combination with ritonavir, peginterferon alfa, and ribavirin.
2. Dosage and Administration
Recommended Dosage:
Danoprevir Sodium: 100 mg orally twice daily.
Ritonavir (Pharmacokinetic Booster): 100 mg orally twice daily.
Duration: Continuous treatment for 12 weeks.
Administration Instructions:
Can be taken with or without food.
Danoprevir must be co-administered with ritonavir to enhance bioavailability.
Must be administered as part of a triple/quadruple regimen including peginterferon alfa and ribavirin.
3. Mechanism of Action
HCV NS3/4A Serine Protease Inhibitor:
Danoprevir is a direct-acting antiviral (DAA) agent.
Pathway:
It binds to the HCV NS3/4A protease, forming a complex with a low dissociation rate.
Physiological Effect:
This inhibition prevents the cleavage of the viral polyprotein, thereby blocking viral replication and assembly.
4. Safety and Warnings
Hematologic Abnormalities:
Anemia, neutropenia, leukopenia, and thrombocytopenia may occur, primarily associated with the concomitant use of peginterferon alfa and ribavirin. Monitor complete blood counts regularly.
Hepatic Enzyme Elevations:
Elevations in ALT and AST may occur. Monitor liver function tests before and during treatment.
Hypersensitivity Reactions:
Hypersensitivity reactions, including rash, have been reported. Discontinue if severe reactions occur.
Contraindications:
Hypersensitivity to danoprevir or any excipients. Contraindicated with strong CYP3A inducers (e.g., rifampin, carbamazepine).
5. Adverse Reactions
Most Common:
Anemia, neutropenia, leukopenia, thrombocytopenia, pruritus, rash, nausea, vomiting, diarrhea, fever, and fatigue.
6. Drug Interactions
CYP3A Substrates/Inhibitors/Inducers:
Danoprevir is metabolized by CYP3A. Concomitant use with strong CYP3A inducers (e.g., rifampin, phenobarbital, phenytoin, carbamazepine) is contraindicated as it significantly reduces danoprevir plasma concentrations.
P-gp Inducers:
Drugs that induce P-glycoprotein (P-gp) may decrease danoprevir absorption.
Interactions with Peginterferon/Ribavirin:
Additive toxicities (e.g., bone marrow suppression) are expected with concomitant use.
7. Pharmaceutical Information
Chemical Name:
Sodium (2R,6S,12Z,13aS,14aR,16aS)-6-(tert-butoxycarbonylamino)-2-[(4-fluoroisoindoline-2-carbonyl)oxy]-5,16-dioxo-1,2,3,5,6,7,8,9,10,11,13a,14,14a,15,16,16a-pentadecahydrocyclopropa[e]pyrrolo[1,2-a]diazacyclopentadecine-14a-cyclopropylsulfonamide.
Molecular Formula:C35H46FN5O9S • Na.
Storage:Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.