AGAMREE Oral suspension Ref.[107213] Active ingredients: Vamorolone

Treatment with AGAMREE should only be initiated by specialist physicians with experience in the management of Duchenne muscular dystrophy.

Posology

The recommended dose of vamorolone is 6 mg/kg once daily in patients weighing less than 40 kg.

In patients weighing 40 kg and above, the recommended dose of vamorolone is 240 mg (equivalent to 6 ml) once daily.

Daily dose may be down-titrated to 4 mg/kg/day or 2 mg/kg/day based on individual tolerability.

Patients should be maintained at the highest tolerated dose within the dose range.

Table 1. Dosing table:

The dose of vamorolone must not be decreased abruptly if the treatment has been administered for more than one week (see section 4.4). Dose tapering should be done progressively over weeks, by steps of approximately 20% decrease from the previous dose level. The duration of each tapering step should be adjusted depending on individual tolerability.

Special populations

Hepatic impairment

No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh class A).

The recommended daily dose of vamorolone for patients with moderate hepatic impairment (Child-Pugh class B) is 2 mg/kg/day for patients up to 40 kg and 80 mg for patients with a body weight of 40 kg and above (see section 5.2). Patients with severe hepatic impairment (Child-Pugh class C) should not be treated with vamorolone. See sections 4.3 and 4.4.

Paediatric population

The safety and efficacy of AGAMREE in children below 4 years of age has not been established.

Method of administration

AGAMREE is for oral use. AGAMREE can be taken with or without a meal (see section 5.2). The oral suspension requires redispersing by shaking the bottle prior to dosing.

Only the oral syringe provided with the medicinal product should be used to measure the dose of AGAMREE in ml. After the appropriate dose is withdrawn into the oral syringe, it should be dispensed directly into the mouth.

The oral syringe should be disassembled after use, rinsed under running cold tap water and air dried. It should be stored in the box until next use. An oral syringe may be used for up to 45 days, then it should be discarded and the second oral syringe provided in the pack should be used.

Treatment of acute overdose is by immediate supportive and symptomatic therapy. Gastric lavage or emesis can be considered.

Before opening:

2 years.

After first opening:

3 months.

Store in a refrigerator (2°C – 8°C) in upright position

This medicinal product does not require any special temperature storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

Amber coloured glass bottle containing 100 ml oral suspension with a polypropylene tamper evident child resistant closure with low density polyethylene liner.

Each pack contains one bottle, one press-in bottle adapter (low density polyethylene) and two identical oral syringes (low density polyethylene) graduated from 0 to 8 ml by increments of 0.1 ml.

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

Each oral syringe supplied with AGAMREE may be used for up to 45 days.