DACLAXEN 60 MG

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

Hepatic viral infections (Hepatitis C)

Daclatasvir stops HCV viral RNA replication and protein translation by directly inhibiting HCV protein NS5A. NS5A is critical for HCV viral transcription and translation.

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 a 24 week

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

Strong or moderate CYP3A4 or P-GP inducers (eg, phenytoin, carbamazepine, phenobarbital, rifampicin, systemic dexamethasone. Strong CYP3A4 inhibitors (eg, boceprevir, telaprevir, HIV protease inhibitors, cobicistat, macrolides, azole antifungals, calcium channel blockers). NNRTIs, dabigatran, digoxin, oral contraceptives, statins, amiodarone

Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampicin, and St. John’s wort Hypersensitivity to the active substance or any of the excipients

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.

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.

Bradycardia with Sofosbuvir 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 Sofosbuvir 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