* Daklanork (Daclatasvir 60 mg) 28 Film-Coated Tablets.
Each film-coated tablet contains:
Daclatasvir dihydrochloride 65.92 mg
equivalent to Daclatasvir 60 mg
** Therapeutic indications:
Daclatasvir is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
** Posology and method of 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. The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daclatasvir.
Recommended regimens and treatment duration are provided as follows:
HCV genotype and patient population # Treatment # Duration:
– Genotype 1 or 4 without cirrhosis : Daclatasvir + sofosbuvir : 12 weeks – Consider prolongation of treatment to 24 weeks for patients with prior treatment including a NS3/4A protease inhibitor
– Genotype 1 or 4 with compensated cirrhosis : Daclatasvir + sofosbuvir : 24 weeks – Shortening treatment to 12 weeks may be considered for previously untreated patients with cirrhosis and positive prognostic factors such as IL28B CC genotype and/or low baseline viral load. – Consider adding ribavirin for patients with very advanced liver disease or with other negative prognostic factors such as prior treatment experience.
– Genotype 3 without cirrhosis : Daclatasvir + sofosbuvir : 12 weeks
– Genotype 3 with cirrhosis : Daclatasvir + sofosbuvir +/- ribavirin : 24 weeks – Ribavirin may be added based on clinical assessment of an individual patient.
– Genotype 4 : Daclatasvir + peginterferon alfa + ribavirin : 24 weeks of Daclatasvir in combination with 24-48 weeks of peginterferon alfa and ribavirin. – If the patient has HCV RNA undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks. If the patient achieves HCV RNA undetectable, but not at both treatment weeks 4 and 12, Daclatasvir should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
The dose of ribavirin, when combined with Daclatasvir, is weight-based (1,000 or 1,200 mg in patients <75 kg or ?75 kg, respectively). ** Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX14 ** Mechanism of action: Daclatasvir 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. ** Store at temperature not exceeding 30 degrees C, in dry place. Keep away from reach of children.