Dasabuvir


Concise Prescribing Info
Indications/Uses
Chronic hepatitis C genotype 1.
Dosage/Direction for Use
Adult : PO 250 mg bid, given w/ other antivirals.
Dosage Details
Oral
Chronic hepatitis C
Adult: In patients w/ chronic hepatitis C genotype 1: 250 mg bid in the morning and evening, in combination w/ other antivirals. Recommended treatment duration: 12 or 24 wk.
Hepatic Impairment
Moderate (Child-Pugh B): Not recommended. Severe (Child-Pugh C): Contraindicated.
Contraindications
HIV co-infection w/o suppressive antiretroviral therapy. Severe hepatic impairment. Co-admin w/ ethinylestradiol-containing products, strong or moderate enzyme inducers, strong CYP2C8 inhibitors, systemic tacrolimus, sirolimus, or everolimus.
Special Precautions
Patient w/ hepatitis B virus infection. Moderate hepatic impairment. Not intended for admin as monotherapy.
Adverse Reactions
Significant: Elevated ALT.
Nervous: Insomnia, fatigue, asthenia.
GI: Nausea.
Haematologic: Anaemia.
Dermatologic: Pruritus, angioedema.
Potentially Fatal: Hepatic decompensation and hepatic failure.
Drug Interactions
May affect the efficacy of vit K antagonists. Increases exposure to rosuvastatin. Decreased exposure to CYP2C19 substrate (e.g. lansoprazole). Increased plasma concentration w/ teriflunomide, deferasirox.
Potentially Fatal: Increased risk of ALT elevations w/ ethinylestradiol-containing products. Decreased plasma levels and therapeutic effect w/ strong or moderate enzyme inducers (e.g. carbamazepine, efavirenz, rifampicin). Increased plasma levels w/ strong CYP2C8 inhibitors (e.g. gemfibrozil). Increases the concentration of systemic tacrolimus, sirolimus, or everolimus.
Food Interaction
Increased absorption w/ food. Decreased plasma levels w/ St. John’s wort.
Action
Description: Dasabuvir is a non-nucleoside inhibitor of non-structural protein 5B (NS5B), an RNA-dependent RNA polymerase which is an essential component of the hepatitis C virus replication process.
Pharmacokinetics:
Absorption: Absorbed from the GI tract. Increased absorption w/ food. Time to peak plasma concentration: 4-5 hr.
Distribution: Plasma protein binding: >99.5% (dasabuvir); 94.5% (M1 metabolite).
Metabolism: Metabolised mainly by CYP2C8, and to a lesser extent by CYP3A.
Excretion: Elimination half-life: Approx 6 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Dasabuvir, CID=56640146, https://pubchem.ncbi.nlm.nih.gov/compound/Dasabuvir (accessed on Jan. 20, 2020)

Storage
Store below 30°C.
Any unused portions should be disposed of in accordance w/ local requirements.
MIMS Class
ATC Classification
J05AP09 - dasabuvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
References
Buckingham R (ed). Dasabuvir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/06/2017.

Joint Formulary Committee. Dasabuvir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/06/2017.

Disclaimer: This information is independently developed by MIMS based on Dasabuvir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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