Finished product reference
Dasabuvir
Tablet · Oral · 250 mg
- List code
- 52507
- Pharmacologic class
- Direct-acting antiviral (non-nucleoside HCV NS5B polymerase inhibitor)
What it is and how it works
Dasabuvir is a non-nucleoside inhibitor that binds the palm domain of the HCV NS5B RNA-dependent RNA polymerase, blocking viral RNA replication. It is active against genotype 1 and is used only with ombitasvir/paritaprevir/ritonavir.
Indications
Treatment of chronic hepatitis C genotype 1 infection in adults, in combination with ombitasvir/paritaprevir/ritonavir, with or without ribavirin.
Dosage and administration (summary)
250 mg orally twice daily (morning and evening) with food, in combination with ombitasvir/paritaprevir/ritonavir, usually for 12 weeks (longer in some patients with cirrhosis).
Contraindications
Moderate or severe hepatic impairment (Child–Pugh B or C); ethinylestradiol-containing medicines; strong or moderate enzyme inducers and strong CYP2C8 inhibitors (e.g. gemfibrozil); and all contraindications of ombitasvir/paritaprevir/ritonavir.
Warnings and precautions
Hepatic decompensation and failure have occurred, mainly in patients with advanced cirrhosis; monitor liver function. ALT elevations, particularly in women taking ethinylestradiol, have been seen. Screen for hepatitis B because of the risk of HBV reactivation; many ritonavir-related drug interactions must be reviewed.
Pregnancy
Not recommended in pregnancy; when used with ribavirin, strict contraception is required in women and in female partners of male patients.
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.
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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