MAVIRET Film-coated tablet Ref.[10436] Active ingredients: Glecaprevir Glecaprevir and Pibrentasvir Pibrentasvir

Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.

Posology

Adults, adolescents aged 12 years and older, or children weighing at least 45 kg

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 (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 or kidney transplant patients

A 12-week treatment duration has been evaluated and is recommended in liver or kidney transplant recipients with or without cirrhosis (see section 5.1). 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 aged less than 3 years or under 12 kg have not been established and no data are available.

Maviret coated granules formulation is intended for children aged 3 to less than 12 years weighing 12 kg to less than 45 kg. Refer to the Summary of Product Characteristics for Maviret coated granules in sachet for dosing instructions based on body weight. Because the formulations have different pharmacokinetic profiles, the tablets and the coated granules are not interchangeable. A full course of treatment with the same formulation is therefore required (see section 5.2).

Method of administration

For oral use.

Patients should be instructed to swallow tablets whole with food and not to chew, crush or break the tablets as it may alter the bioavailability of the agents (see section 5.2).

The highest documented doses administered to healthy volunteers is 1 200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir. Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥7 days. In case of overdose, the patient should be monitored for any signs and symptoms of toxicities (see section 4.8). Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by haemodialysis.

5 years.

This medicinal product does not require any special storage conditions.

PVC/PE/PCTFE aluminium foil blister packs.

Pack containing 84 (4 cartons of 21 tablets) film-coated tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.