Daclatasvir

Adults: Recommended Dosage: The recommended dose of Daclatasvir is 60 mg once daily, taken by mouth with or without food. Daclatasvir must always be given together with other medicines. Before starting treatment with Daclatasvir, the Summary of Product Characteristics for the other medicines in the regimen should also be consulted. The recommended regimens and treatment durations are shown in the table below. For the Daclatasvir plus Sofosbuvir regimen, data on a 12-week treatment duration are available only for treatment-naïve patients with genotype 1 infection. For Daclatasvir plus Sofosbuvir, with or without Ribavirin, data are available for patients with advanced liver disease (≥F3) without cirrhosis. The recommended use of Daclatasvir plus Sofosbuvir in genotype 4 is based on extrapolation from genotype 1. For the Daclatasvir plus Peginterferon alfa plus Ribavirin regimen, data are available for treatment-naïve patients. When Ribavirin is combined with Daclatasvir, its dose is based on body weight (1,000 mg for patients under 75 kg, or 1,200 mg for patients of 75 kg or more). Dose modification, interruption and discontinuation: Changing the dose of Daclatasvir to manage side effects is not recommended. If treatment with any component of the regimen has to be interrupted because of side effects, Daclatasvir must not be continued on its own as monotherapy. There are no virologic stopping rules for the combination of Daclatasvir with Sofosbuvir. Treatment should be discontinued in patients who show an inadequate virologic response while on Daclatasvir, Peginterferon alfa and Ribavirin. Dose recommendation for concomitant medicines: Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4): the dose of Daclatasvir should be reduced to 30 mg once daily when given with strong CYP3A4 inhibitors. Moderate inducers of CYP3A4: the dose of Daclatasvir should be increased to 90 mg once daily when given with moderate CYP3A4 inducers. Missed doses: Patients should be told that if they miss a dose of Daclatasvir, it should be taken as soon as possible if remembered within 20 hours of the scheduled time. If the missed dose is remembered more than 20 hours after the scheduled time, it should be skipped and the next dose taken at the usual time.