Active Ingredient: Mirabegron
Mirabegron is indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 3 and patient weight is ≥ 11 kg and patient weight is < 22 kg, granule, for suspension, extended release oral, between 3 milliliters mirabegron and 6 milliliters mirabegron, once daily to meals. The maximum allowed total dose is 6 milliliters mirabegron daily.
Regimen B: In case that patient age in years is ≥ 3 and patient weight is ≥ 22 kg and patient weight is < 35 kg, granule, for suspension, extended release oral, between 4 milliliters mirabegron and 8 milliliters mirabegron, once daily to meals. The maximum allowed total dose is 8 milliliters mirabegron daily.
Regimen C: In case that patient age in years is ≥ 3 and patient weight is ≥ 35 kg, granule, for suspension, extended release oral, between 6 milliliters mirabegron and 10 milliliters mirabegron, once daily to meals. The maximum allowed total dose is 10 milliliters mirabegron daily.
Regimen D: In case that patient age in years is ≥ 3 and patient weight is ≥ 35 kg, tablet, extended release oral, 25 milligrams mirabegron, once daily to meals, over the duration of 4 to 8 weeks. Afterwards, in case that patient age in years is ≥ 3 and patient weight is ≥ 35 kg, tablet, extended release oral, between 25 milligrams mirabegron and 50 milligrams mirabegron, once daily to meals. The maximum allowed total dose is 50 milligrams mirabegron daily.
Paediatric patients 3 to less than 18 years of age with NDO may be administered mirabegron prolonged-release tablets or mirabegron granules for prolonged-release oral suspension based on the body weight of the patient. The prolonged-release tablets may be administered to patients weighing 35 kg or more; the granules for prolonged-release oral suspension are recommended for patients below 35 kg. Patients administered 6 ml oral suspension dose may be switched to 25 mg tablet dose and patients administered 10 ml oral suspension dose may be switched to 50 mg tablet dose.
The recommended starting dose of mirabegron prolonged-release tablets is 25 mg once daily with food. If needed, the dose may be increased to a maximum dose of 50 mg once daily with food after 4 to 8 weeks. During long-term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated.
Patients should be instructed to take any missed doses, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.
The recommended dose of mirabegron granules for prolonged-release oral suspension is determined based on patient weight and should be administered once daily with food. Treatment should be initiated at the recommended starting dose. Thereafter, the dose may be increased to the lowest effective dose. The maximum dose should not be exceeded. Patients who reach 35 kg or more while on treatment may be switched from oral suspension to tablet formulation if they can swallow tablets. Patients administered 6 ml oral suspension dose may be switched to 25 mg tablet dose and patients administered 10 ml oral suspension dose may be switched to 50 mg tablet dose. During long-term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated.
The following table provides the doses for oral suspension by body weight range.
Table 1. Daily oral suspension dosing recommendations for paediatric NDO patients aged 3 to less than 18 years according to patient body weight:
| Body weight range (kg) | Starting dose (ml) | Maximum dose (ml) |
|---|---|---|
| 11 to <22 | 3 | 6 |
| 22 to <35 | 4 | 8 |
| ≥35 | 6 | 10 |
Patients should be instructed to take any missed doses, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.
The tablet is to be taken with liquids, swallowed whole, and is not to be chewed, divided, or crushed. It should be taken with food.
Mirabegron granules for prolonged-release oral suspension is intended for oral use and should be taken once daily with food.
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