DASIKAST

Description

DESCRIPTION

Dacikast 60mg (Daclatasvir) is an inhibitor of non-structural protein 5A (NS5A). Each film-coated tablet contains Daclatasvir Dihydrochloride equivalent to Daclatasvir 30 mg or 60mg. Empirical formula for Daclatasvir Dihydrochloride is C40H50N8 O6. 2HCl. Daclatasvir is white to yellow colour solid and freely soluble in water. The tablets include the following inactive ingredients: Anhydrous Lactose, Microcrystalline cellulose, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate, Opadry Orange

Mechanism of Action

Dasikast Tablets Daclatasvir 60mg is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex. Daclatasvir inhibits both viral RNA replication and virion assembly.

Pharmacodynamics

Antiviral activity in cell culture Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC50) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method. The Daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus. Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) protease inhibitors, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system. No antagonism of antiviral activity was observed. No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that Daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV.

Pharmacokinetics

The pharmacokinetic properties of Dasikast (Daclatasvir) were evaluated in healthy adult subjects and in patients with chronic HCV. Following multiple oral doses of Daclatasvir 60 mg once daily in combination with peg interferon alfa and ribavirin in treatment naive patients with genotype 1 chronic HCV, the geometric mean (CV%) Daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng*h/ml, and Cmin was 232 (83) ng/ml.

INDICATIONS AND USAGE

Dacikast is indicated in combination with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection.

DOSAGE AND ADMINISTRATION

Treatment with Dacikast should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. The recommended dose of Dacikast is 60 mg once daily, to be taken orally with or without meals. Dacikast must be administered in combination with other medicinal products. The Package Inserts of the other medicinal products in the regimen should also be consulted before initiation of therapy with Dacikast. Recommended regimens and treatment duration are provided in Table 1

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the Excipients Co administration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daclatasvir. These active substances include but are not limited to phonation, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John’s worth (Hypericum perforatum).

WARNINGS AND PRECAUTIONS

Dacikast must not be administered as monotherapy. Dacikast must be administered in combination with other medicinal products for the treatment of chronic HCV infection.

General

The safety and efficacy of the combination of Daclatasvir and sofosbuvir have been evaluated in a limited number of patients with cirrhosis in clinical studies.

Decompensated liver disease

The safety and efficacy of Daclatasvir in the treatment of HCV infection in patients with decompensate liver disease have not been established.

Retreatment with Daclatasvir

The efficacy of Daclatasvir as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.

Pregnancy and contraception requirements

Daclatasvir should not be used during pregnancy or in women of childbearing potential not using contraception. Use of highly effective contraception should be continued for 5 weeks after completion of Daclatasvir therapy.

OVERDOSAGE

There is limited experience of accidental overdose of Daclatasvir in clinical trials. In phase 1 clinical trials, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions. There is no known antidote for overdose of Daclatasvir. Treatment of overdose with Daclatasvir should consist of general supportive measures, including monitoring of vital signs, and observation of the patient’s clinical status. Because Daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of Daclatasvir

HOW SUPPLIED AND STORAGE

Dacikast 30 mg tablets are available in bottle pack of 28 tablets. Dacikast 60 mg tablets are available in bottle pack of 28 tablets. Store below 25°C.

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