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    Safety

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    Evaluation of Safety: Monotherapy

    The safety profile of Myrbetriq has been evaluated in adult patients with overactive bladder (OAB) in three 12-week trials and a 1-year safety study.1

    Safety and tolerability studied in three 12-week phase III trials1

    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

    Chart showing results of 12 week safety study

    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

    • The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2, and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia
    • Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by >1 patient and at a rate greater than placebo
    Study Design

    Safety evaluated in a 1-year, randomized, fixed-dose, double‑blind, active-controlled study1

    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

    Chart showing results of 1 year safety study in elderly patients

    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

    • Adverse reactions leading to discontinuation in patients treated with Myrbetriq 50 mg (reported by >2 patients and >active control) included constipation (0.9%), headache (0.6%), dizziness (0.5%), hypertension (0.5%), dry eyes (0.4%), nausea (0.4%), vision blurred (0.4%), and urinary tract infection (0.4%)
    • Serious adverse events (reported by ≥2 patients and >active control) included cerebrovascular accident (0.4%) and osteoarthritis (0.2%)
    • Serum ALT/AST increased from baseline by greater than 10 fold in 2 patients (0.3%) taking Myrbetriq 50 mg; these markers subsequently returned to baseline while both patients continued Myrbetriq
    • Serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients treated with Myrbetriq 50 mg, 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with Myrbetriq 100 mg included breast cancer, lung neoplasm malignant, and prostate cancer. A causal relationship between mirabegron and these reported neoplasms has not been established
    Study Design
    12-Week Safety

    Safety and tolerability studied in three 12-week phase III trials1

    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

    Chart showing results of 12 week safety study

    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

    • The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2, and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia
    • Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by >1 patient and at a rate greater than placebo
    Study Design
    1-Year Safety

    Safety evaluated in a 1‑year, randomized, fixed-dose, double‑blind, active-controlled study1

    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

    Chart showing results of 1 year safety study in elderly patients

    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

    • Adverse reactions leading to discontinuation in patients treated with Myrbetriq 50 mg (reported by >2 patients and >active control) included constipation (0.9%), headache (0.6%), dizziness (0.5%), hypertension (0.5%), dry eyes (0.4%), nausea (0.4%), vision blurred (0.4%), and urinary tract infection (0.4%)
    • Serious adverse events (reported by ≥2 patients and >active control) included cerebrovascular accident (0.4%) and osteoarthritis (0.2%)
    • Serum ALT/AST increased from baseline by greater than 10 fold in 2 patients (0.3%) taking Myrbetriq 50 mg; these markers subsequently returned to baseline while both patients continued Myrbetriq
    • Serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients treated with Myrbetriq 50 mg, 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with Myrbetriq 100 mg included breast cancer, lung neoplasm malignant, and prostate cancer. A causal relationship between mirabegron and these reported neoplasms has not been established
    Study Design

    Hear from a peer

    Dr. Christopher R. Chapple discusses the results of a 1‑year study examining the safety profile of Myrbetriq.

    Play video of Dr Christopher R. Chapple, MD, DHC, FRCS
    References

    References

    1. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci 2008;9(6):453-66.
    2. 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.
    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, Macarthur H, Westfall, DP. Neurotransmission: The Autonomic and Somatic Motor Nervous Systems. In: Brunton L, Hilal-Dandan R, Knollman B, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 13th ed. New York, NY: McGraw Hill, 2018.
    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.

    Hear from a peer

    Dr. Christopher R. Chapple discusses the results of a 1‑year study examining the safety profile of Myrbetriq.

    The Safety Profile of Myrbetriq in Elderly Patients: Monotherapy

    Safety evaluated in 12-week analysis3,4

    Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age

    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

    Chart showing results of 12 week safety study in elderly patients

    Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age3

    • The frequency of serious AEs was generally greater in patients ≥65 years of age than patients <65 years of age3
    • The frequency of serious AEs was generally greater in patients ≥75 years of age than patients <75 years of age3
    • Adverse events leading to discontinuation among patients ≥65 years of age were numerically similar for Myrbetriq 25 mg, Myrbetriq 50 mg, and placebo (4.5%, 5.6% and 5.0%, respectively)4
    Study Design

    Safety evaluated in a 1-year study3,4

    Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age

    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

    Chart showing results of 1 year safety study in elderly patients
    • The frequency of serious AEs was generally greater in patients ≥65 years of age than patients <65 years of age3
    • The frequency of serious AEs was generally greater in patients ≥75 years of age than patients <75 years of age3

    Safety Evaluated at Week 12 and at 1 Year3,4

    Pre-specified subgroup analysis in patients ≥65 years (n=1674 of 4427) and ≥75 years (n=478 of 4427) of age3,4

    • At both Week 12 and 1 year, the frequency of serious AEs was generally greater in patients ≥65 years of age than patients <65 years of age4
    • At Week 12, adverse events leading to discontinuation among patients ≥65 years of age were numerically similar for Myrbetriq 25 mg, Myrbetriq 50 mg, and placebo (4.5%, 5.6% and 5.0%, respectively)4
    • No overall differences in safety or effectiveness were observed between patients <65 years and those >65 years of age in the Phase II and III studies of Myrbetriq1
    • The pharmacokinetics of Myrbetriq were similar in elderly and adult volunteers1
    Study Design

    PILLAR Safety: Results from the First Prospective Study of Myrbetriq in Adults ≥65

    Safety evaluated in a double-blind, randomized, placebo-controlled, parallel-group, multicenter Phase IV follow-up study.5

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

    *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.
    ‡Preferred term; affecting ≥2% of any treatment group.
    §Escherichia urinary tract infection, streptococcal urinary tract infection, urinary tract infection, or bacterial urinary tract infection.
    Study Design

    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® (mirabegron extended-release tablets) 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. 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;63:283‑95. 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):666-75. 5. 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.