Presentation

Each Tablet contains Daclatasvir Dihydrochloride INN equivalent to Daclatasvir 60 mg.

Description

Daclatasvir is a potent and specific inhibitor of the HCV NS5A replication complex. The HCV NS5A is a multifunctional protein with key functions in HCV replication and modulation of cellular signaling pathways.

Indications

Daclatasvir is indicated in combination with Sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Dosage & Administration

The recommended dose of Daclatasvir is 60 mg once daily, to be taken orally with or without meals. Daclatasvir must be administered in combination with other medicinal products.

HCV-monoinfected or HCV/HIV coinfected patients with chronic hepatitis C without cirrhosis, including treatment-naïve patients and patients who failed on a treatment based on Peginterferon alfa & Ribavirin

– All genotypes: Daclatasvir + Sofosbuvir for 12 weeks

HCV-monoinfected or HCV/HIV coinfected patients with chronic hepatitis C with compensated (Child-Pugh A) cirrhosis, including treatment-naïve patients and patients who failed on a treatment based on Peginterferon alfa & Ribavirin

– Genotype 1,4,5,6: Daclatasvir + Sofosbuvir for 24 weeks or Daclatasvir + Sofosbuvir + Ribavirin for 12 weeks

– Genotype 2: Daclatasvir + Sofosbuvir for 12 weeks

– Genotype 3 : Daclatasvir + Sofosbuvir + Ribavirin for 24 weeks

The dose of Ribavirin, when combined with Daclatasvir, is weight-based (1000 or 1200 mg in patients <75 kg or ≥75 kg, respectively).

Side Effects

Daclatasvir in combination with Sofosbuvir

Fatigue, headache, nausea

Daclatasvir in combination with Peginterferon alfa and Ribavirin

The most frequently reported adverse reactions were fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anaemia, pyrexia, cough, dyspnoea, neutropenia, diarrhoea and arthralgia. The most frequently reported adverse reactions (frequency of 1% or greater) were neutropenia, anaemia and lymphopenia. The safety profile of daclatasvir in combination with Peginterferon alfa and Ribavirin was similar to that seen with Peginterferon alfa and Ribavirin alone, including among patients with cirrhosis.

Precautions

Bradycardia with Sofobuvir and Amiodarone coadministration: Serious symptomatic

bradycardia may occur in patients taking amiodarone with Sofosbuvir in combination

with Daclatasvir, particularly in patients also receiving beta blockers, or those with

underlying cardiac comorbidities and/or advanced liver disease. Coadministration

of amiodarone with Sofobuvir in combination with Daclatasvir is not recommended.

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

Use in Pregnancy & Lactation

There are no data from the use of daclatasvir in pregnant women.

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.

It is not known whether daclatasvir is excreted in human milk.

Drug Interaction

Strong or moderate CYP3A4 or P-gp inducers (eg, phenytoin, carbamazepine, phenobarbital, rifampicin, systemic dexamethasone, St John\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’s wort) or

Strong CYP3A4 inhibitors (eg, boceprevir, telaprevir, HIV protease inhibitors, cobicistat, macrolides, azole antifungals, calcium channel blockers). NNRTIs, dabigatran, digoxin, oral contraceptives, statins, amiodarone

Commercial Pack

Virodacla 12:Each box contains 3 blister strips of 4 tablets.

Virodacla 28: Each container contains 28 tablets.

Others

Pediatric Use: The safety and efficacy of Daclatasvir in children and adolescents aged <18 years have not yet been