Finished product reference
Daclatasvir
Tablet · Oral · 60 mg
- List code
- 50358
- Pharmacologic class
- Direct-acting antiviral (hepatitis C virus NS5A inhibitor)
What it is and how it works
Daclatasvir inhibits the HCV non-structural protein 5A (NS5A), which is essential for viral RNA replication and virion assembly. It is always used in combination with other antivirals, typically sofosbuvir.
Indications
Treatment of chronic hepatitis C virus infection in adults, in combination with other medicinal products such as sofosbuvir (with or without ribavirin).
Dosage and administration (summary)
60 mg orally once daily for 12 weeks (or 24 weeks in selected patients), in combination with sofosbuvir; reduce to 30 mg daily with strong CYP3A4 inhibitors and increase to 90 mg daily with moderate CYP3A4 inducers.
Contraindications
Co-administration with strong CYP3A4 or P-glycoprotein inducers (e.g. rifampicin, carbamazepine, phenytoin, St John’s wort), which markedly reduce daclatasvir exposure.
Warnings and precautions
Severe bradycardia and heart block have occurred when sofosbuvir-containing regimens are used with amiodarone. Hepatitis B reactivation can occur in co-infected patients, so screen for HBV before treatment. Numerous drug interactions via CYP3A4 and P-gp must be reviewed.
Pregnancy
Not recommended in pregnancy; women of childbearing potential should use effective contraception.
Storage and supply
Store below 30 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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