Safety
Percent of patients with adverse reactions derived from all adverse events, exceeding placebo rate and reported by ≥1% of patients treated with Myrbetriq 25 mg or 50 mg once daily in Studies 1, 2, and 31
aIncludes reports of blood pressure (BP) above the normal range and BP increased from baseline, occurring predominantly in subjects with baseline hypertension.
Myrbetriq was evaluated in three 12‑week, double‑blind, randomized, placebo‑controlled,
parallel‑group, multicenter clinical trials in patients with OAB.1
Percent of patients with adverse reactions derived from all adverse events, reported by >2% of patients treated with Myrbetriq 50 mg once daily in the 1 year safety study1
bThe active control in this study was tolterodine extended-release (ER) 4 mg.2
Myrbetriq was evaluated in a 1-year, randomized, fixed‑dose, double‑blind, active‑controlled study1
*Myrbetriq was also evaluated for safety in 1632 patients who received Myrbetriq 50 mg once daily (n=812 patients) or Myrbetriq 100 mg (n=820 patients) in a 1‑year study in patients with OAB (Study 4). Of these patients, 731 received Myrbetriq in a previous 12‑week study. In Study 4, 1385 patients received Myrbetriq continuously for at least 6 months, 1311 patients received Myrbetriq for at least 9 months, and 564 patients received Myrbetriq for at least 1 year.
Percent of patients with adverse reactions derived from all adverse events, exceeding placebo rate and reported by ≥1% of patients treated with Myrbetriq 25 mg or 50 mg once daily in Studies 1, 2, and 31
aIncludes reports of blood pressure (BP) above the normal range and BP increased from baseline, occurring predominantly in subjects with baseline hypertension.
Myrbetriq was evaluated in three 12‑week, double‑blind, randomized, placebo‑controlled, parallel‑group, multicenter clinical trials in patients with OAB.1
Percent of patients with adverse reactions derived from all adverse events, reported by >2% of patients treated with Myrbetriq 50 mg once daily in the 1 year safety study1
bThe active control in this study was tolterodine extended-release (ER) 4 mg.2
Myrbetriq was evaluated in a 1‑year, randomized, fixed‑dose, double‑blind, active‑controlled study1
Dr. Christopher R. Chapple discusses the results of a 1‑year study examining the safety profile of Myrbetriq.
Dr. Christopher R. Chapple discusses the results of a 1‑year study examining the safety profile of Myrbetriq.
Percent of patients ≥65 and ≥75 years of age with adverse reactions derived from all adverse events, exceeding placebo rate and reported by ≥3% of patients in any treatment group in the ≥65 year subgroup4
Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age3
Percent of patients ≥65 and ≥75 years of age with adverse reactions derived from all adverse events, exceeding placebo rate and reported by ≥3% of patients in any treatment group in the ≥65 year subgroup4
Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age3,4
Percent of patients with treatment-emergent adverse events (TEAEs)* who received ≥1 dose of study medication
Myrbetriq® (mirabegron), a beta-3 adrenergic agonist, is indicated as monotherapy or in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.
Myrbetriq alone or in combination with solifenacin succinate can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of hypertension was reported infrequently in Myrbetriq clinical trial patients with OAB.
In patients taking Myrbetriq, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; 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 antimuscarinic medications for the treatment of OAB, including solifenacin succinate.
Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. Cases of angioedema have been reported to occur after the first dose, 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 such as metoprolol and desipramine 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, such as thioridazine, flecainide, and propafenone.
In clinical trials, the most commonly reported adverse reactions (> 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 (> 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, constipation, 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).
1. Myrbetriq [Prescribing Information]. Northbrook, IL: Astellas Pharma US, Inc. 2. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European–Australian phase 3 trial. Eur Urol. 2013;63:283‑295. 3. Astellas. Myrbetriq. Data on File. 4. Wagg A, Cardozo L, Nitti VW, et al. The efficacy and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients. Age Ageing. 2014:43(5):666-675. 5. Wagg A, Staskin D, Engel E, Herschorn S, Kristy RM, Schermer CR. Efficacy, safety, and tolerability of mirabegron in patients aged ≥65 years with overactive bladder-wet: a Phase IV, double-blind, randomised, placebo-controlled study (PILLAR). Eur Urol. (In press) 11-13-2019.
Myrbetriq® (mirabegron), a beta-3 adrenergic agonist, is indicated as monotherapy or in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.
Myrbetriq alone or in combination with solifenacin succinate can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of hypertension was reported infrequently in Myrbetriq clinical trial patients with OAB.
In patients taking Myrbetriq, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; 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 antimuscarinic medications for the treatment of OAB, including solifenacin succinate.
Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. Cases of angioedema have been reported to occur after the first dose, 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 such as metoprolol and desipramine 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, such as thioridazine, flecainide, and propafenone.
In clinical trials, the most commonly reported adverse reactions (> 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 (> 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, constipation, 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).
