PRESCRIBING INFORMATION (PI)
MAVIRET® ▼100 mg/40 mg film-coated tablets
PRESENTATION: Each Maviret film-coated tablet contains 100 mg of glecaprevir and 40 mg pibrentasvir. Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
INDICATION: For treatment of Chronic hepatitis C Virus (HCV) infection in adults and in adolescents aged 12 to <18 years.
DOSAGE AND ADMINISTRATION: Oral. Treatment to be initiated and monitored by physician experienced in HCV management.
Dosage: The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily at the same time with food.
Treatment Duration: Patients without prior therapy: GT 1, 2, 3, 4, 5, 6 with or without cirrhosis: 8 weeks. Patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: GT 1, 2, 4-6 and no cirrhosis: 8 weeks. GT 1, 2, 4-6 and cirrhosis: 12 weeks. GT3 with or without cirrhosis: 16 weeks.
Special Populations: HIV Co-infection: No dose adjustment required. For dosing with HIV antiviral agents refer to SmPC for additional information. Liver or kidney transplant patients: 12 weeks in transplant recipients with or without cirrhosis, with 16 weeks considered for GT3 patients who are treatment experienced as above. Elderly: No dose adjustment required. Renal impairment: No dose adjustment required. Hepatic impairment: No dose adjustment required in patients with mild hepatic impairment (Child-Pugh A). Not recommended in patients with moderate hepatic impairment (Child-Pugh B) and contraindicated in patients with severe hepatic impairment (Child-Pugh C). Paediatric Population: No dose adjustment of Maviret is required in adolescents aged 12 to <18 years. The safety and efficacy of Maviret in children aged less than 12 years have not yet been established.
CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate and ethinyl oestradiol-containing products. Maviret in combination with strong
P-gp and CYP3A inducers: examples include; carbamazepine, phenytoin, phenobarbital, primidone, rifampicin, St. John’s Wort (Hypericum perforatum).
SPECIAL WARNINGS AND PRECAUTIONS: Hepatitis B virus (HBV) screening should be performed in all patients prior to treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should be monitored and managed according to current clinical guidelines. No re-treatment data is available for patients infected with genotypes 2, 3, 5 or 6. Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors. Glucose levels of diabetic patients initiating therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary. The physician in charge of the diabetic care of the patient should be informed when Maviret therapy is initiated. Maviret contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
INTERACTIONS: See SmPC for full details. Not Recommended: darunavir, efavirenz, lopinavir/ritonavir, lovastatin, ciclosporin
doses > 100 mg daily, moderate inducers of P-gp/CYP3A. Use with Caution: digoxin, pravastatin, fluvastatin, pitavastatin, rosuvastatin, tacrolimus. Monitor Levels: Monitor INR with all vitamin K antagonists. Coadministration with P-gp, BCRP or OATP1B1/3 inhibitors may increase antiviral concentrations.
PREGNANCY AND LACTATION: Pregnancy: not recommended. Lactation: It is not known whether Maviret and its metabolites are excreted in breast milk. Fertility: No human data on the effect of glecaprevir and/or pibrentasvir are available.
SIDE EFFECTS: See SmPC for full details on side effects. Very common side effects (≥1/10): headache, fatigue. Common side effects (≥1/100 to <1/10): diarrhoea, nausea, asthenia. Less than 0.1% of subjects treated with Maviret had serious adverse reactions. Uncommon side effects (≥ 1/1,000 to < 1/100): angioedema. Not known side effects: pruritus.
LEGAL CATEGORY: POM
MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/BASIC NHS COST: Maviret 100 mg/40 mg film-coated tablets; daily blister packs containing 3 film-coated tablets, inner cartons containing 21 film-coated tablets in multipack presentation containing 84 (4 packs of 21) film-coated tablets. EU/1/17/1213/001: £12,993.66
FURTHER INFORMATION: available from AbbVie Ltd, Maidenhead, SL6 4UB
DATE OF REVISION: April 2020