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

Dosage & Administration - Recommended Dosage: 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 in table below: For the regimen of Daclatasvir+Sofosbuvir, data for 12-week treatment duration are available only for treatment-naïve patients with genotype 1 infection. For Daclatasvir+Sofosbuvir with or without Ribavirin, data are available for patients with advanced liver disease (≥F3) without cirrhosis. The recommended use of Daclatasvir+Sofosbuvir in genotype 4 is based on extrapolation from genotype 1. For the regimen of Daclatasvir+Peginterferon alfa + Ribavirin, data are available for treatment-naïve patients. 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). Dose modification, interruption and discontinuation: Dose modification of Daclatasvir to manage adverse reactions is not recommended. If treatment interruption of components in the regimen is necessary because of adverse reactions, Daclatasvir must not be given as monotherapy. There are no virologic treatment stopping rules that apply to the combination of Daclatasvir with Sofosbuvir. Treatment discontinuation in patients with inadequate on-treatment virologic response during treatment with 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 coadministered with strong inhibitors of CYP3A4. Moderate inducers of CYP3A4: The dose of Daclatasvir should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4. Missed doses: Patients should be instructed that, if they miss a dose of Daclatasvir, the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time. However, if the misse

Side Effects - The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone. One can get any of the following symptoms: Fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, tiredness, shortness of breath, chest pain, confusion, memory problems.

Contraindications - Daclatasvir is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daclatasvir. Contraindicated drugs include, but are not limited to, Anticonvulsants (phenytoin, carbamazepine), Antimycobacterial agents (rifampin), Herbal Products st.Jhon’s wort (Hypericum perforatum).

Others - Pregnancy & Lactation No data with Daclatasvir in pregnant women are available to inform a drug-associated risk. No information regarding the presence of Daclatasvir in human milk, the effects on the breastfed infant, or the effects on milk production is available.