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BetmigaTest .pdf


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BETMIGA IS AN ENTIRELY NEW APPROACH TO OAB
Betmiga is the first ß3-adrenoceptor agonist licensed to treat OAB.1

A once-daily tablet that works differently to antimuscarinics1,2

Relaxes the bladder during the storage phase via stimulation of ß3-adrenergic receptors in the
detrusor muscle1

Improves storage capacity and inter-void interval, without impeding voluntary voiding1

Mode of action of OAB treatments2
PARASYMPATHETIC

SYMPATHETIC
(Adrenergic control )

(Cholinergic control)
Activates
ß3-adrenergic
receptor

Blocks
muscarinic
receptor

Detrusor
muscle wall
Antimuscarinics

Increases
relaxation

Inhibits involuntary
contractions

Delayed voiding

Bladder

ß3-adrenoceptor
agonist
(Betmiga)

Increased storage capacity
+ inter-void interval
Adapted from Chu et al., 2006.

Prescribing information can be found on the second last page.

AN EFFECTIVE OAB TREATMENT3,4
In a key European-Australian phase III trial, Betmiga 50 mg:
• Significantly reduced the number of incontinence episodes and micturitions over 24 hours vs. placebo3

Improvements in co-primary endpoints3
Incontinence episodes / 24h (FAS-1)
n=291

n=300

n=293

2.67

2.63

2.83

Baseline
0

-0.2
-0.4
-0.6
-0.8
-1.0
-1.2
-1.4
-1.6

-1.17

Improvement
vs. placebo

-1.27
n.s.
p=0.11

-1.57
*

p=0.003

-1.8
-2.0

34.2%
(-0.41)†

Mean change from baseline (events)

Mean change from baseline (episodes)

Baseline
0

Micturitions / 24h (FAS)
n=475

n=473

11.71

11.55

11.65

-0.2
-0.4
-0.6
-0.8
-1.0
-1.2
-1.4
-1.6
-1.8
-2.0

Placebo

n=480

Tolterodine ER 4 mg

Improvement
vs. placebo

-1.34
-1.59
n.s.
p=0.11

-1.93
*

44.0%
(-0.60)‡

p<0.001

Betmiga 50 mg

Adapted from Khullar et al., 2013. Analysis of changes from baseline to final visit in a double-blind, randomised, placebo- and active-controlled phase III trial in
1987 OAB patients (study 046). FAS = full analysis set; FAS-I = all full analysis set patients who had ≥1 incontinence episode at baseline. *Statistically significant
improvement vs. placebo. n.s. no statistically significant difference vs. placebo. Tolterodine ER (extended-release) 4 mg was included as an active control in this study.

Adjusted mean difference vs. placebo (95% two-sided CI: -0.72, -0.09). ‡Adjusted mean difference vs. placebo (95% two-sided CI: -0.90, -0.29).

• Demonstrated significant improvements in a range of secondary OAB and health-related
quality of life measures vs. placebo1,3,5

WITH A MODE OF ACTION THAT’S WELL TOLERATED3,4
• Incidences of dry mouth and constipation, the two most bothersome side-effects
with antimuscarinics, were similar to placebo with Betmiga 50 mg3,6

Incidence of common treatment emergent adverse events (≥2%)3
Placebo

Betmiga 50 mg

Tolterodine ER 4 mg

(n=494)

(n=493)

(n=495)

Dry mouth

2.6%

2.8%

10.1%

Constipation

1.4%

1.6%

2.0%

Hypertension

7.7%

5.9%

8.1%

Nasopharyngitis

1.6%

2.8%

2.8%

Headache

2.8%

3.7%

3.6%

Influenza

1.6%

2.2%

1.4%

Urinary tract infection

1.4%

1.4%

2.0%

Adverse events, %

Table adapted from Khullar et al., 2013.

The long-term safety and tolerability of Betmiga 50 mg in OAB patients over a 12-month period
is supported by a European-North American phase III trial.4

BETMIGA offers a fresh start in oab
Betmiga 50 mg is an effective treatment for OAB patients.1,3,4
• Including treatment-naïve and those who discontinued antimuscarinic therapy
due to lack of efficacy1
Betmiga 50 mg is well tolerated and helps relieve the burden of OAB.1,3,4
• Dry mouth rate was comparable to placebo3
• Significantly improved patient quality of life compared with placebo1,3

Prescribing Information.
Presentation: Betmiga™ prolonged-release
tablets containing 25 mg or 50 mg mirabegron.
Indication: Symptomatic treatment of urgency,
increased micturition frequency and/or urgency
incontinence as may occur in adult patients with
overactive bladder (OAB) syndrome. Dosage:
Adults (including the elderly): Recommended dose:
50 mg once daily with or without food. Children and
adolescents: Should not be used. Contraindications:
Hypersensitivity to active substance or any of the
excipients. Warnings and Precautions: Has not
been studied in patients with end-stage renal
disease, severe hepatic impairment or severe
uncontrolled hypertension and therefore should not
be used. Dose adjustment to 25 mg is recommended
in patients with severe renal and moderate hepatic
impairment. Not recommended in patients with
severe renal impairment or moderate hepatic
impairment concomitantly receiving strong
CYP3A inhibitors. Dose adjustment to 25 mg is

recommended in patients with moderate renal or
mild hepatic impairment receiving strong CYP3A
inhibitors concomitantly. Caution in patients with a
known history of QT prolongation or in patients
taking medicines known to prolong the QT interval.
Not recommended during pregnancy and in women
of childbearing potential not using contraception.
Not recommended during breastfeeding.
Interactions: Clinically relevant drug interactions
between Betmiga™ and medicinal products that
inhibit, induce or are a substrate for one of the
CYP isozymes or transporters are not expected,
except for inhibitory effect on the metabolism of
CYP2D6 substrates. Betmiga™ is a moderate and
time-dependant inhibitor of CYP2D6 and weak
inhibitor of CYP3A. No dose adjustment needed
when administered with CYP2D6 inhibitors
or CYP2D6 poor metabolisers. Caution if
co-administered with medicines with a narrow
therapeutic index and significantly metabolised by

CYP2D6. Caution is also advised if mirabegron is
co-administered with CYP2D6 substrates that are
individually dose titrated. When initiating in
combination with digoxin the lowest dose for
digoxin should be prescribed and serum digoxin
should be monitored. Adverse Effects: Urinary
tract infection, tachycardia, palpitations, atrial
fibrillation, blood pressure increase, leukocytoclastic
vasculitis. Prescribers should consult the Summary of
Product Characteristics in relation to other side effects.
Pack and Prices: Country specific. Legal
Category: POM. Product Licence Number:
Betmiga™ 25 mg EU/1/12/809/001-007;
Betmiga™ 50 mg EU/1/12/809/008-14. Date
of Preparation: January 2013. Further
information available from: Astellas Pharma
Europe Ltd, 2000 Hillswood Drive, Chertsey,
Surrey, KT16 0RS, UK. Betmiga™ is a Registered
Trademark. For full prescribing information please
refer to the Summary of Product Characteristics.

Adverse events should be reported. Report adverse events to Astellas Pharma Europe by email to safety-eu@astellas.com,
by facsimile to +31 (0)71-545 5208, or contact your local Astellas office (www.astellas.eu/contact/locations/)
References: 1. Betmiga Summary of Product Characteristics, February 2013. 2. Chu F, Dmouchwski R. Am J Med 2006; 119: 3S–8S. 3. Khullar V et al. Eur Urol 2013; 63: 283–95.
4. Chapple CR et al. Eur Urol 2013; 63: 296–305. 5. Astellas data on file, MIR/12/0001/EU. 6. Athanasopoulos A, Giannitsas K. Adv Urol 2011; 820816. Epub 2011 Jan 7.

Date of preparation: August 2013

MIR6552 digi ads leavepiece Flash.indd 4

Approval code: BET/13/0104/EU

14/08/2013 18:24

It’s time to think
of something else.

The first ß -adr
enoceptor agon
3
ist
to treat overac
tive bladder

A fresh start in OAB


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