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
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.
1. Igawa Y, Yamazaki Y, Takeda H, et al. Functional and molecular biological evidence for a possible β3‑adrenoceptor in the human detrusor muscle. Br J Pharmacol 1999;126(3):819‑25. 2. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci 2008;9(6):453‑66. 3. Ursino MG, Vasina V, Raschi E, Crema F, De Ponti F. The β3‑adrenoceptor as a therapeutic target: current perspectives. Pharmacol Res 2009;59(4):221‑34. 4. Westfall TC, Westfall DP. Neurotransmission: the autonomic and somatic motor nervous systems. In: Brunton LL, Chabner BA, Knollmann BC, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw‑Hill; 2011:171‑18. 5. Yamaguchi O. β3-adrenoceptors in human detrusor muscle. Urology 2002;59(suppl):25‑29. 6. Chu FM, Dmochowski R. Pathophysiology of overactive bladder. Am J Med 2006;119(3A):3S‑8S. 7. Myrbetriq [Prescribing Information]. Northbrook, IL: Astellas Pharma US, Inc. 8. Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized double‑blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β3‑adrenoceptor agonist, in overactive bladder. Eur Urol 2013,63(2):296‑305.
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
The pharmacokinetics of Myrbetriq were similar in elderly and adult volunteers, and no dose adjustment is necessary for elderly patients.1
To see clinical studies and elderly patient data click here
Myrbetriq® (mirabegron) is a beta‑3 adrenergic agonist indicated 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.
Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.
Myrbetriq 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 ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm 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.
Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. In some cases angioedema occurred after the first dose. Cases of angioedema 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 such as metoprolol and desipramine is increased when co‑administered with Myrbetriq. 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 25 mg and 50 mg 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 postmarketing experience, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.
Please see accompanying 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.
Myrbetriq® (mirabegron) is a beta‑3 adrenergic agonist indicated 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.
Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.
Myrbetriq 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 ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm 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.
Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. In some cases angioedema occurred after the first dose. Cases of angioedema 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 such as metoprolol and desipramine is increased when co‑administered with Myrbetriq. 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 25 mg and 50 mg 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 postmarketing experience, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.
Please see accompanying complete Prescribing Information for Myrbetriq® (mirabegron).
