Maviret 100mg/40mg film-coated tablets
AbbVie Limited
contact details
Active ingredient
glecaprevir
pibrentasvir
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
Maviret 100 mg/40 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
Excipient with known effect
Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with 'NXT'.
4. Clinical particulars
4.1 Therapeutic indications
Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4. and 5.1).
4.2 Posology and method of administration
Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Posology
The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily with food (see section 5.2).
The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.
Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy
Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin
For patients who failed prior therapy with an NS3/4A- and/or an NS5A-inhibitor, see section 4.4.
Missed dose
In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken. If more than 18 hours have passed since Maviret is usually taken, the missed dose should not be taken and the patient should take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.
If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken. If vomiting occurs more than 3 hours after dosing, an additional dose of Maviret is not needed.
Elderly
No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Renal impairment
No dose adjustment of Maviret is required in patients with any degree of renal impairment including patients on dialysis (see sections 5.1 and 5.2).
Hepatic impairment
No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A). Maviret is not recommended in patients with moderate hepatic impairment (Child Pugh-B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3, 4.4, and 5.2).
Liver transplant patients
Maviret may be used for a minimum of 12 weeks in liver transplant recipients (see section 4.4). A 16 week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin.
Patients with HIV-1 Co-infection
Follow the dosing recommendations in Tables 1 and 2. For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Paediatric population
The safety and efficacy of Maviret in children and adolescents aged less than 18 years have not yet been establish |
