Maviret

Maviret

Manufacturer:

AbbVie

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Glecaprevir 100 mg, pibrentasvir 40 mg
Indications/Uses
Treatment of chronic hepatitis C virus (HCV) infection in adults & in adolescents 12 to <18 yr.
Dosage/Direction for Use
300 mg/120 mg (3 tab) once daily. HCV genotype 1, 2, 3, 4, 5, or 6-infected patient w/o prior HCV therapy, w/ compensated cirrhosis or w/o cirrhosis Treatment duration: 8 wk. HCV genotype 1, 2, 4, 5, or 6-infected patient who failed prior therapy w/ peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin Treatment duration: 8 wk in patient w/o cirrhosis; 12 wk in patient w/ compensated cirrhosis. Liver or kidney transplant recipients w/ compensated cirrhosis or w/o cirrhosis Treatment duration: 12 wk. HCV genotype 3-infected patient who failed prior therapy w/ peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin, w/ compensated cirrhosis or w/o cirrhosis Treatment duration: 16 wk.
Administration
Should be taken with food: Swallow whole, do not break/chew/crush.
Contraindications
Hypersensitivity. Concomitant use w/ atazanavir-containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp & CYP3A inducers [eg, rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarb, phenytoin, & primidone]. Severe hepatic impairment (Child-Pugh C).
Special Precautions
Risk of HBV reactivation in HBV/HCV co-infected patients during or after treatment. Perform HBV screening before initiation of treatment. Not recommended for re-treatment of patients w/ prior exposure to NS3/4A- &/or NS5A-inhibitors. Diabetics may experience improved glucose control after treatment initiation. Closely monitor glucose levels of diabetic patients, particularly w/in the first 3 mth. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ moderate hepatic impairment (Child-Pugh B).
Adverse Reactions
Headache; fatigue. Diarrhoea, nausea; asthenia.
Drug Interactions
Increased plasma conc of substrates of P-gp (eg, dabigatran etexilate, digoxin), BCRP (eg, rosuvastatin), or OATP1B1/3 (eg, atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin). Close monitoring of INR values is recommended in patients treated w/ vit K antagonists. Decreased plasma conc w/ strong P-gp & CYP3A inducers [eg, rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarb, phenytoin, & primidone], & moderate P-gp/CYP3A inducers (eg, oxcarbazepine, eslicarbazepine, lumacaftor, crizotinib). Increased plasma conc w/ P-gp & BCRP inhibitors (eg, ciclosporin, cobicistat, dronedarone, itraconazole, ketoconazole, ritonavir). Glecaprevir: Increased systemic conc w/ OATP1B1/3 inhibitors (eg, elvitegravir, ciclosporin, darunavir, lopinavir).
MIMS Class
ATC Classification
J05AP57 - glecaprevir and pibrentasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Presentation/Packing
Form
Maviret FC tab
Packing/Price
4 × 21's
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