For your adult patients with symptoms of OAB, Myrbetriq is indicated for the treatment of urge urinary incontinence, urgency, and urinary frequency1

Help your elderly patients manage their OAB symptoms

Learn more about coverage, safety & efficacy of Myrbetriq Monotherapy–
the
first FDA-approved β3-adrenergic agonist1

Myrbetriq is the
#1 prescribed branded
OAB medication2*

*Based on IQVIA claims data of 24-month TRx shares for all branded OAB medications, May 2021-April 2023.

THIS INFORMATION DOES NOT IMPLY SAFETY OR EFFICACY OF ANY PRODUCT; NO COMPARISONS SHOULD BE MADE.

Your elderly patients ≥65 years can see meaningful improvement in daily OAB symptoms of urinary incontinence and frequency with Myrbetriq.3†

Myrbetriq was evaluated in a pre-specified subgroup analysis of patients ≥65 years of age from three Phase III pivotal clinical trials. Myrbetriq was also studied in the PILLAR trial–a prospective, double-blind, randomized, placebo-controlled, parallel-group, multicenter Phase IV study of community-dwelling patients ≥65 years of age with wet OAB symptoms for ≥3 months.

Safety result

See clinical studies, efficacy results, and safety, including a subset analysis of elderly patients

The PILLAR study is the first prospective study to examine the efficacy, safety, and tolerability of Myrbetriq in adults ≥65 years of age with wet OAB symptoms3

Study Design: PILLAR, the First Prospective Study of Myrbetriq in Adults ≥65 Years of Age

Efficacy demonstrated in a double-blind, randomized, placebo-controlled, parallel-group, multicenter Phase IV study3

Efficacy Endpoints

  • Co-primary Endpoint: Change from baseline to end of treatment (EoT) in the mean number of urinary incontinence episodes per 24 hours
  • Co-primary Endpoint: Change from baseline to EoT in the mean number of micturitions per 24 hours
  • Secondary Endpoint: Change from baseline to EoT in mean volume voided per micturition

Entry Criteria

  • Male and female community-dwelling patients ≥65 years of age
  • Wet OAB symptoms (defined as urgency, urinary frequency, and urinary incontinence) for ≥3 months
  • ≥8 micturition episodes per 24 hours
  • ≥3 urgency episodes
  • ≥1 urinary incontinence episode

Treatment Arms and Timeline

After a 2-week placebo run-in period, those who entered the 12-week treatment period were randomized to Myrbetriq 25 mg or placebo and were given the option to increase to 50 mg at Week 4 or Week 8 based on individual efficacy, tolerability, and investigator discretion.

This study was designed to detect a difference between placebo and total mirabegron groups and not for each individual mirabegron dosing group.

PILLAR Efficacy Results

Adjusted mean change from Baseline to EoT3

Incontinence

Co-primary Endpoint

Incontinence episodes
per 24 hours

Change from baseline to end of treatment (EoT) in mean number of urinary incontinence episodes per 24 hours3

  • 38% of elderly patients receiving Myrbetriq achieved zero incontinence vs 30% in the placebo group (OR 1.50, 95% CI 1.09, 2.06)
OR = odds ratio.
OR = odds ratio.
Micturition

Co-primary Endpoint

Micturition frequency
per 24 hours

Change from baseline to EoT in the mean number of micturitions per 24 hours3

CI = confidence interval; EoT = end of treatment.

PILLAR Safety and Tolerability Results

Percent of patients with treatment-emergent adverse events (TEAEs) who received ≥1 dose of study medication3

Treatment-emergent adverse event (TEAE) is defined as an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.

§ Possible or probable, as assessed by the investigator, or where relationship was missing.

II Preferred term; affecting ≥2% of any treatment group.

Escherichia urinary tract infection, streptococcal urinary tract infection, urinary tract infection, or bacterial urinary tract infection.

Elderly Efficacy & Safety Flashcard

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PILLAR Clinical Flashcard

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Mechanism of Action

Learn how Myrbetriq targets
the β3-AR pathway

View MOA

Dosing & Administration

See information about dosing


View Dosing

Important Safety Information,
Indications and Usage

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INDICATIONS AND USAGE

MYRBETRIQ® (mirabegron extended-release tablets), either alone or in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

IMPORTANT SAFETY INFORMATION

MYRBETRIQ is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet.

MYRBETRIQ monotherapy or in combination with solifenacin succinate can increase blood pressure in adults. Periodic blood pressure determinations are recommended, especially in hypertensive patients. MYRBETRIQ is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of pre-existing hypertension was reported infrequently in patients taking MYRBETRIQ.

In patients taking MYRBETRIQ, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, MYRBETRIQ should still be administered with caution to patients with clinically significant BOO. For example, monitor these patients for signs and symptoms of urinary retention. MYRBETRIQ should also be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB, including solifenacin succinate.

Angioedema of the face, lips, tongue and/or larynx has been reported with MYRBETRIQ. In some cases, angioedema occurred after the first dose. Cases have been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue MYRBETRIQ and initiate appropriate therapy and/or measures necessary to ensure a patent airway.

Since MYRBETRIQ is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when co‐administered with MYRBETRIQ. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.

In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo) for MYRBETRIQ 25mg and 50mg versus placebo, respectively, were hypertension (11.3%, 7.5% vs. 7.6%), nasopharyngitis (3.5%, 3.9% vs. 2.5%), urinary tract infection (4.2%, 2.9% vs. 1.8%), and headache (2.1%, 3.2% vs. 3.0%).

In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo and > comparator) for MYRBETRIQ in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus MYRBETRIQ 25mg, MYRBETRIQ 50mg, solifenacin succinate 5mg, and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).

In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, diarrhea, and dizziness.

Please refer to prescribing information for solifenacin succinate when prescribing MYRBETRIQ in combination with solifenacin succinate.

Please click here for complete Prescribing Information for Myrbetriq® (mirabegron extended-release tablets)

References

1. Myrbetriq [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Astellas. Myrbetriq. Data on File. 3. Wagg A, Staskin D, Engel E, Herschorn S, Kristy RM, Schermer CR. Efficacy, safety, and tolerability of mirabegron in patients aged ≥65yr with overactive bladder wet: a phase IV, double-blind, randomised, placebo-controlled study (PILLAR). Eur Urol 2020;77(2):211-20.