Daclatasvir Drug Specification

I. Indications and Usage It is a hepatitis C virus (HCV) NS5A inhibitor indicated for the treatment of chronic hepatitis C infection in genotype 3 infection. Limitations of use: Reduced rates of sustained virologic response (SVR) in patients with cirrhosis. II. Dosage and Administration  60 mg once daily in combination with Sofosbuvir, taken orally on an empty stomach or with food.  Recommended duration of treatment: 12 weeks.  Dose modification: reduce dose to 30 mg once daily with strong CYP3A inhibitors; increase dose to 90 mg once daily with moderate CYP3A inducers. Patient population Recommended duration of treatment Untreated with or without cirrhosis 12 weeks Treated + without cirrhosis 12 weeks Treated + with cirrhosis 24 weeks III. Dosage forms and specifications Tablets: 60 mg and 30 mg IV. Precautions Bradycardia occurs in combination with sofosbuvir and amiodarone: patients taking amiodarone with sofosbuvir and another HCV direct antiviral drug (including: daclatasvir) Severe symptomatic bradycardia may occur in patients taking amiodarone with sofosbuvir and another HCV direct antiviral drug (including: daclatasvir), especially if the patient is also taking a beta-blocker or has heart disease and/or advanced liver disease. Daclatasvir is not recommended for concomitant administration with amiodarone and sofosbuvir. Cardiac monitoring is recommended for patients who have no other treatment options. V. ADVERSE REACTIONS The most common adverse reactions (≥10%) observed with sofosbuvir in combination with daclatasvir were headache and fatigue. VI. Drug interactions Drug interactions: Concomitant administration of daclatasvir can alter the concentration of other drugs, and the concentration of other drugs can alter the concentration of daclatasvir. Refer to the full prescribing information before using prohibited drugs and other potential drug interactions. For safety and efficacy in pregnancy, lactating women, children, elderly, renal impairment, and hepatic impairment, please refer to the full Prescribing Information.