Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
The recommended dose is 50 mg once daily.
Betmiga has not been studied in patients with end stage renal disease (GFR <15 mL/min/1.73 m² or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see sections 4.4 and 5.2).
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors (see sections 4.4, 4.5 and 5.2).
Table 1. Daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors:
| Strong CYP3A inhibitors3 | |||
|---|---|---|---|
| Without inhibitor | With inhibitor | ||
| Renal impairment1 | Mild | 50 mg | 25 mg |
| Moderate | 50 mg | 25 mg | |
| Severe | 25 mg | Not recommended | |
| Hepatic impairment2 | Mild | 50 mg | 25 mg |
| Moderate | 25 mg | Not recommended | |
1 Mild: GFR 60 to 89 mL/min/1.73 m²; moderate: GFR 30 to 59 mL/min/1.73 m²; severe: GFR 15 to 29 mL/min/1.73 m².
2 Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
3 Strong CYP3A inhibitors see section 4.5
No dose adjustment is necessary according to gender.
The safety and efficacy of mirabegron in children below 18 years of age have not yet been established.
No data are available.
The tablet is to be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. It may be taken with or without food.
Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.
Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Shelf life: 3 years.
Shelf life after first opening of the bottle: 6 months.
This medicinal product does not require any special storage conditions.
Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets. HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets. Each carton contains one bottle.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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