BETMIGA™ (mirabegron) is indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Treatment of neurogenic
detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.1

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BETMIGA is a selective and potent beta 3-adrenoceptor agonist established in clinical practice for more than a decade for the treatment of patients with overactive bladder (OAB).1 

BETMIGA was approved by EMA in 2012.1

EFFICACY

BETMIGA significantly reduces incontinence episodes vs. placebo1,2

This graph shows improvements in incontinence episodes in the SCORPIO trial. The x-axis represents time from baseline to week 12, and the y-axis represents the mean change from baseline. The graph compares three groups: Betmiga 50mg, placebo, and Tolterodine ER 4mg. Betmiga 50mg shows a significant improvement in incontinence episodes over the 12-week period compared with placebo. Figure adapted from Khullar et al. 2013.

BETMIGA significantly reduces micturition frequency vs. placebo1,2

This graph shows improvements in micturitions in the SCORPIO trial. The x-axis represents time from baseline to week 12, and the y-axis represents the mean change from baseline. The graph compares three groups: Betmiga 50mg, placebo, and Tolterodine ER 4mg. Betmiga 50mg shows a significant improvement in micturitions over the 12-week period compared with placebo. Figure adapted from Khullar et al. 2013.

PRACTICAL USE AND SAFETY

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How to initiate treatments for OAB

For adults (including elderly patients) with OAB the recommended dose is BETMIGA 50 mg once daily. 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.1

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Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients.1


Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.1

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Adverse events

Like all medicines, BETMIGA can cause adverse reactions although not everybody gets them. Common adverse reactions (≥1/100 to <1/10) are urinary tract infection, headache*, dizziness*, tachycardia, nausea*, constipation*and diarrhoea*.1 (*=observed during post-marketing surveillance.)

NB: Follow-up consultations can improve the persistence to the overactive bladder treatment.3

ELDERLY PATIENTS

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The prevalence of OAB increases with age, affecting approximately 30% of individuals >65 years of age4 which makes the study design of the PILLAR study very relevant for clinical practice. The PILLAR study is a phase IV study comparing flexibly dosed (25–50 mg) BETMIGA* versus placebo in elderly patients with OAB and urgency incontinence.5

The patient population represents a subpopulation of the patients in the randomised placebo-controlled trials described in BETMIGA SmPC and comprises elderly patients, including those aged 75 years and older, having several comorbidities and concomitant medications. A patient group who is often underrepresented in clinical trials.

Relevant patient population for 
clinical practice

Baseline5

  • ≥65 years (28% ≥75 years)
  • Comorbidities: mean 8.2 (hypertension 58%; osteoarthritis 36%)
  • Polypharmacy: mean 6.5 concomitant medications
  • Mild or moderate cognitive impairment in 25% (by the MoCA test6)
  • OAB wet

BETMIGA was well tolerated5

  • Findings were consistent with the known BETMIGA safety profile1
  • Overall TEAE rates were similar in both groups, see table 1 below
  • The most common TEAEs in BETMIGA-treated patients were urinary tract infection, headache and diarrhoea





Improvements in OAB symptoms5

Statistically significant improvements in primary endpoints from baseline to EOT, BETMIGA (n=437) vs placebo (n=430)

  • Mean number of micturitions/24h/Age≥65: Difference (SE): –0.7 (0.2); 95% CI: –1.0, –0.3; p<0.001
  • Mean number of incontinence episodes/24h/Age≥65: Difference (SE): –0.6 (0.1); 95% CI: –0.8, 
–0.3; p<0.001
  • Findings were consistent with Phase 3 trials7

No relevant change in cognitive function5

  • No statistically relevant change in cognitive function as measured by the MoCA
  • From baseline to EOT, with adjusted mean (SE) changes of –0.1 (0.1) points for placebo and –0.2 (0.1) for BETMIGA 
This table compares the safety parameters of TEAEs (Treatment-Emergent Adverse Events) between Placebo and BETMIGA total. BETMIGA shows higher overall and drug-related TEAEs but similar rates of serious TEAEs and treatment discontinuation.Table adapted from Wagg A, et al, 2020.

Table 1. Adapted from Wagg A, et al, 2020. Incidences of TEAEs were similar in both groups (safety analysis set).


*The recommended BETMIGA dose for adults based on the SmPC is 50 mg daily, whereas patients in this study initially received 25 mg daily and only increased their dose to 50 mg after Week 4 or 8 based on individual efficacy/tolerability and investigator discretion.

 

MoCA=The Montreal Cognitive Assessment; EOT=End of Treatment; SE=Standard Error; TEAE=Treatment Emergent Adverse Event

PAEDIATRIC PATIENTS WITH NDO

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Indication: Treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.1

Neurogenic detrusor overactivity is defined as involuntary detrusor contractions during bladder filling, where a relevant neurological cause is present. The most common cause of NDO is congenital spinal defects; other causes include spinal cord injuries or central nervous system abnormalities.8

A main objective for treatment is to maintain low bladder pressure during storage and voiding in order to avoid associated complications such as urinary tract infections, bladder stones, fibrosis, trabeculation, and autonomic dysreflexia.8

The NDO indication for paediatric patients is based on reference 8: 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.

Dosage and administration

Only for administration to patients weighing 35 kg or more. Starting dose is 25 mg once daily with food. The tablet is to be taken with liquids, 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. 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

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

 

For dosing recommendations for children and adolescents with impaired kidney or liver function, see Table 2 in the SmPC.1

 

Adverse events


In the paediatric patients with NDO, no severe adverse reactions were reported.1,8 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.1

 

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

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REFERENCES:

1. BETMIGA SmPC §4.1, 4.2, 4.3, 4.8, 5.1, 9. 08.2024. 2. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63(2):283-295 (Study 046 in SmPC). 3. Ali M, Grogan S, Powell S, et al. Qualitative analysis of factors influencing patient persistence and adherence to prescribed overactive bladder medication in UK primary care. Adv ther. 2019;36:3110-22. 4. Nitti VW, Khullar V, van Kerrebroeck P, et al. Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. Int J Clin Pract. 2013;67(7):619-632. 5. Wagg A, Staskin D, Engel E, et al. Efficacy, safety, and tolerability of mirabegron in patients aged ≥65 year with overactive bladder wet: a phase IV, double-blind, randomized, placebo-controlled study (PILLAR). Eur Urol. 2020;77:211-220. 6. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699. 7. Wagg A, Cardozo L, Nitti VW, et al. The efficacy and tolerability of the beta3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients. Age Ageing. 2014;43:666-675. 8. 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.

COMPULSORY INFORMATION

BETMIGA™ (mirabegron) 25 og 50 mg depottabletter

Farmakoterapeutisk gruppe: Urologisk spasmolytikum, selektiv β3-adrenoseptoragonist (G04BD12).
Indikasjoner: Symptomatisk behandling av «urgency», økt vannlatingsfrekvens og/eller urgeinkontinens hos voksne med overaktiv blæresyndrom (OAB). Behandling av nevrogen detrusoroveraktivitet (NDO) hos pediatriske pasienter i alderen 3-<18 år.
*Dosering og administrering: Voksne med overaktiv blære (≥18 år ): 50 mg 1 gang daglig, med eller uten mat. Barn og ungdom 3-<18 år, ≥35 kg, med nevrogen detrusoroveraktivitet (NDO): Startdosen er 25 mg 1 gang daglig med mat. Om nødvendig kan dosen økes til maks. 50 mg 1 gang daglig etter 4-8 uker. Ved alvorlig nedsatt nyrefunksjon (GFR 15-29 mL/min/1,73 m2) eller moderat nedsatt leverfunksjon (Child-Pugh klasse B), anbefales en maks. dose på 25 mg. Tabletten skal tas med væske, svelges hel og må ikke tygges, deles eller knuses.
Kontraindikasjoner: Overfølsomhet for innholdsstoffene. Alvorlig ukontrollert hypertensjon definert som systolisk blodtrykk ≥180 mm Hg og​/​eller diastolisk blodtrykk ≥110 mm Hg.
*Forsiktighetsregler: Nedsatt nyre- og leverfunksjon: Betmiga er ikke studert hos pasienter med terminal nyresykdom (GFR <15 mL/min/1,73 m2), pasienter som krever hemodialyse, eller pasienter med alvorlig leverfunksjonssvikt (Child-Pugh klasse C), og anbefales derfor ikke for bruk i disse pasientgruppene. Anbefales ikke til bruk hos pasienter med alvorlig nedsatt nyrefunksjon (GFR 15-29 mL/min/1,73 m2) eller pasienter med moderat nedsatt leverfunksjon (Child-Pugh klasse B) som samtidig mottar sterke CYP3A-hemmere. Hypertensjon: Kan øke blodtrykket hos både voksne, ungdom og barn. Blodtrykksøkning hos barn (3-<12 år) kan være høyere enn hos ungdom (12-<18 år). Blodtrykk bør måles ved oppstart og jevnlig under behandlingen, spesielt hos hypertensive pasienter. Forsiktighet må utvises til pasienter med medfødt eller ervervet QT-forlengelse, klinisk signifikant blæreutløpsobstruksjon og pasienter som bruker antimuskarinbehandling for overaktiv blære. Graviditet, amming og fertilitet: Anbefales ikke til fertile kvinner som ikke bruker prevensjon, eller under graviditet eller amming. Effekten av mirabegron på menneskelig fertilitet er ikke fastslått.
*Bivirkninger: De vanligst rapporterte bivirkningene er takykardi, urinveisinfeksjon, hodepine, svimmelhet, kvalme, forstoppelse og diaré. Samlet sett er sikkerhetsprofilen hos barn og ungdom lik den som er observert hos voksne. Hos barn og ungdom med NDO ble det ikke rapportert noen alvorlige bivirkninger. De vanligst rapporterte bivirkningene hos disse var urinveisinfeksjon, forstoppelse og kvalme.
MT-innehaver: Astellas Pharma Europe B.V., Nederland.
Reseptgruppe: C. Refusjon: Refusjonsberettighet bruk: Motorisk hyperaktiv nevrogen blære med lekkasje (urge-inkontinens). Refusjonskoder: ICPC: U04 Urininkontinens; ICD: N39.4 Annen spesifisert urininkontinens. Vilkår: Ingen spesifisert. Pakningsstørrelse og pris (pr 10.03.2025): 25 mg: 30 tabletter (blister) 438.50 NOK; 90 tabletter (blister) 1203.70 NOK. 50 mg: 30 tabletter (blister) 438.50 NOK; 90 tabletter (blister) 1203.70 NOK. Lokal representant: Astellas Pharma,Tel: +47 66764600. For mer informasjon se www.felleskatalogen.no.

Basert på SmPC godkjent: 22.08.2024.

*Avsnittet er omskrevet og/eller forkortet sammenlignet med den godkjente preparatomtalen SmPC.

Preparatomtalen kan bestilles kostnadsfritt fra den lokale representanten.