Company: AbbVie Ltd.
Legal category: Prescription. Hospital only. Sport permitted.
Active ingredient: Dasabuvir (as sodium monohydrate) 250mg.
Description: Beige, ovaloid, film-coated tablets marked AV2.
Presentation: 2, 56; price available on request.
Indication: Treatment of chronic hepatitis C in patients with genotype 1 in combination with other drugs.
Pharmacology: Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome. Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Dosage: Adult: Swallow whole with food. One tablet twice daily. For specialist use only. Genotype 1b (including HIV-1 co-infection): Patients without cirrhosis, Exviera + ombitasvir/ paritaprevir/ ritonavir, 12 weeks; patients with compensated cirrhosis, Exviera + ombitasvir/ paritaprevir/ ritonavir + ribavirin, 12 weeks. Genotype 1a (including HIV-1 co-infection and unknown genotype 1 subtype/ mixed genotype 1): Exviera + ombitasvir/ paritaprevir/ ritonavir + ribavirin (patients without cirrhosis, 12 weeks; patients with compensated cirrhosis, 24 weeks). Liver transplant recipients: Exviera and ombitasvir/ paritaprevir/ ritonavir + ribavirin (consider lower initial ribavirin dose), 24 weeks. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active ingredients or to any of the excipients. Severe hepatic impairment. Pregnancy, lactation. See ribavirin SPC if used.
Special precautions: Do not use monotherapy; see SPCs of drugs used in combination with Exviera. Do not use for patients with genotypes other than 1, HIV co-infected patients without suppressive antiretroviral therapy. Seek immediate medical advice if signs of liver inflammation occur. Re-treatment (including previous exposure to drugs anticipated to be cross-resistant); no data. HCV/HBV co-infection, safety and efficacy not established. Contains lactose. Driving/using machines.
Drug interactions: Contraindicated: Ethinylestradiol; strong/ moderate enzyme inducers (eg. carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, enzalutamide, mitotane, rifampicin, St. John’s Wort), ketoconazole, strong CYP2C8 inhibitors (e.g. gemfibrozil), lopinavir/ritonavir, NNRTIs other than rilpivirine. Not recommended: Pitavastatin, fluvastatin. Caution: Dabigatran, deferasirox, teriflunomide, sulfasalazine, rilpivirine. Atazanavir, darunavir. Ciclosporin, tacrolimus, omeprazole, esomeprazole/lansoprazole, alprazolam, levothyroxine, imatinib, amlodipine, rosuvastatin. BCRP/ UGT1A1/ UGT1A4/ 1A6/ intestinal UGT2B7/ CYP2C19 substrates, digoxin, warfarin, s-mephenytoin, furosemide.
Adverse drug reactions: Pruritus, anaemia, insomnia, nausea, fatigue.
Full prescribing information and references available from AbbVie Ltd. Telephone: (01) 4287900.