MAVIRET Coated granules Ref.[51252] Active ingredients: Glecaprevir and Pibrentasvir

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

Posology

Children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg

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. The number of sachets and dose based on body weight for children are shown in Table 3. The sachets should be taken together, with food once daily.

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.

Table 3. Recommended dose for children 3 to less than 12 years of age:

The adult dose of Maviret tablets should be used in children weighing 45 kg or greater. Refer to the Summary of Product Characteristics for Maviret film-coated tablets for dosing instructions.

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.

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 weighing under 12 kg have not been established. No data are available. Children weighing 45 kg or more should use the tablet formulation. 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

Oral use.

• Patients should be instructed to take the recommended dose of Maviret with food once daily.
• The granules for the total daily dose (the whole content of the required number of sachets, pink and yellow granules) should be sprinkled on a small amount of soft food with a low water content that will stick to a spoon and can be swallowed without chewing (e.g., peanut butter, chocolate hazelnut spread, soft/cream cheese, thick jam, or Greek yogurt).
• Liquids or foods that would drip or slide off the spoon should not be used as the medicine may dissolve quickly and become less effective.
• The mixture of food and granules should be swallowed immediately; the granules should not be crushed or chewed.
• Maviret granules should not be administered via enteral feeding tubes.

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.

3 years.

This medicinal product does not require any special storage conditions.

Maviret coated granules are supplied in polyethylene terephthalate (PET)/aluminium/polyethylene film sachets in cartons. Each carton contains 28 sachets.

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