For your adult patients with symptoms of OAB, Myrbetriq is indicated for the treatment of urge urinary incontinence, urgency, and urinary frequency1
Learn more about coverage, safety & efficacy of Myrbetriq Monotherapy–
the first FDA-approved β3-adrenergic agonist1
†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.
Efficacy demonstrated in a double-blind, randomized, placebo-controlled, parallel-group, multicenter Phase IV study3
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.
Adjusted mean change from Baseline to EoT3
Co-primary Endpoint
Co-primary Endpoint
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
Download NowPILLAR Clinical Flashcard
Download NowMYRBETRIQ® (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.
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.
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.