Daklanork 60 mg 28 tablets

Tradename

Daklanork (Daklanork)

Compound:

Each tablet contains:

Daclatasvir 60mg

Auxiliary components:

Microcrystalline cellulose, lactose anhydrous, croscarmellose sodium, Aerosil, magnesium stearate, hypromellose, macrogol, talc.

Properties

Daclatasvir is a highly specific direct-acting agent against hepatitis C virus (HCV) and has no significant activity against other RNA and DNA containing viruses, including human immunodeficiency virus (HIV). Daclatasvir is an inhibitor of non-structural protein 5A (NS5A), a multifunctional protein required for HCV replication, and thus inhibits two steps in the viral life cycle — viral RNA replication and virion assembly. Based on in vitro data and computer modeling data, it has been shown that daclatasvir interacts with the N-terminus within domain 1 of the protein, which can cause structural distortions that prevent the implementation of the functions of the NS5A protein. It has been established that the drug is a powerful pangenotypic inhibitor of the hepatitis C virus replication complex of genotypes 1a, 1b, 2a, 3a, 4a, 5a and 6a with effective concentration values (50% reduction, EC50) from picomolar to low nanomolar.

Indications

Treatment of chronic hepatitis C in patients with compensated liver disease (including cirrhosis) with the following daclatasvir combinations:

— with the drug asunaprevir for patients with hepatitis genotype 1b;

— with drugs asunaprevir, peginterferon alfa and ribavirin — for patients with hepatitis genotype 1 virus.

Dosage and administration

The dose and course of treatment is prescribed by the doctor.

The recommended dose is 60 mg once a day. Applied inside, regardless of the meal. Daclatasvir should be used in combination with other medicinal products. Before starting therapy with the drug, you should also read the Instructions for use of the drug for other drugs in relation to the treatment regimen.

Contraindications

— the drug should not be used as monotherapy;

— hypersensitivity to daclatasvir and / or any of the auxiliary components of the drug;

— in combination with strong inducers of the CYP3A4 isoenzyme (due to a decrease in the concentration of daclatasvir in the blood and a decrease in effectiveness), such as:

Side effects

fatigue, headache, pruritus, anemia, influenza-like illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrethecia, myalgia, irritability, cough, diarrhea, dyspnoea, and arthralgia.

Storage method:

Store at a temperature not exceeding 30 degrees.