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BetmigaTM is indicated for the treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.1

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Neurogenic detrusor overactivity (NDO) is characterized by involuntary bladder contractions during bladder filling in the presence of an underlying neurological disorder. NDO is most frequently caused by congenital spinal defects but may also be a result of spinal cord injuries or central nervous system abnormalities.2

A key treatment goal is to keep bladder pressure low during storage and voiding, to help prevent complications such as urinary tract infections, bladder stones, fibrosis, trabeculation, and autonomic dysreflexia.2

Dosage and administration

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Recommended dosage and administration guidelines

Paediatric patients 3 to less than 18 years of age with NDO may be administered Betmiga prolonged-release tablets based on the body weight of the patient. The prolonged-release tablets may be administered to patients weighing 35 kg or more. The tablet is to be taken with food, swallowed whole, and is not to be chewed, divided, or crushed. The dose may be increased to a maximum dose of 50 mg once daily with food after 4 to 8 weeks if needed. For dosing recommendations for children and adolescents with impaired kidney or liver function, see Table 2 in the SmPC.1

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Blood Pressure Monitoring and Safety Considerations

Mirabegron may increase blood pressure in paediatric patients. Blood pressure increases may be larger in children (ages 3 to under 12) compared to adolescents (ages 12 to under 18). Blood pressure should be measured at baseline and regularly monitored during treatment with mirabegron.1

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Long-Term Treatment Evaluation and Dose Adjustment

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.1

Adverse events

In the paediatric patients with NDO, no severe adverse reactions were reported.1,3 The most commonly reported adverse reactions observed in the paediatric population were urinary tract infection, constipation, and nausea.1 Overall, the safety profile in children and adolescents is similar to that observed in adults.

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients. Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg.1

References

1. BETMIGA (mirabegron) prolonged-release tablets. Summary of Product Characteristics. 2. Baka-Ostrowska M, Bolong DT, Persu C, et al. Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open-label, phase 3, dose-titration study. Neurourol Urodyn. 2021;40(6):1490-1499. 3. Sexton CC, Coyne KS, Kopp ZS, Irwin DE, Milsom I, Aiyer LP, et al. The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS. BJU International. 2009 Apr;103:12-23.

Adverse events should be reported. For Ireland, Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel:+353 1 467 1555, E-mail: irishdrugsafety@astellas.com.

MAT-IE-BET-2026-00001 Sep 2026