MyDekla Dosage/Direction for Use

Treatment with Daclatasvir should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Posology: 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 11 as follows (see Pharmacology: Pharmacodynamics under Actions and Precautions): See Table 11.


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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: It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR); therefore discontinuation of treatment is recommended in these patients. The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are presented in Table 12. (See Table 12.)


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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 co-administered with strong inhibitors of CYP3A4.
Moderate inducers of CYP3A4: The dose of Daclatasvir should be increased to 90 mg once daily when co-administered with moderate inducers of CYP3A4. See Interactions.
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 missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next dose taken at the appropriate time.
Special populations: Elderly: No dose adjustment of Daclatasvir is required for patients aged ≥65 years (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Renal Impairment: No dose adjustment of Daclatasvir is required for patients with any degree of renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Daclatasvir is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment. Daclatasvir has not been studied in patients with decompensated cirrhosis (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Paediatric population: The safety and efficacy of Daclatasvir in children and adolescents aged below 18 years have not yet been established. No data are available.
Method of administration: Daclatasvir is to be taken orally with or without meals. Patients should be instructed to swallow the tablet whole. The film-coated tablet should not be chewed or crushed due the unpleasant taste of the active substance.