Important Safety Information
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`Page 1 of 6
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`For your patients with overactive bladder (OAB)
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`Myrbetriq is a β -adrenergic agonist indicated for
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`patients with OAB symptoms of urge urinary
`1
`incontinence, urgency, and urinary frequency.
`
`2 †
`As of April 2017, Myrbetriq is covered for 89% of lives on Medicare Commercial plans. *
`
`*Not a guarantee of coverage. Please verify coverage and updated information with the plan sponsors. Information subject to change
`without notice.
`By Medicare covered lives (39,751,085); Plan types: Medicare MA, Medicare PDP. Source: Business One Technologies, April 2017.
`
`†
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`Mechanism of Action
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`Think β . Think Myrbetriq.
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`3
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`The first and only FDA-approved β -adrenergic agonist.
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`3
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`1
`Myrbetriq is not an antimuscarinic agent. It targets a different receptor signaling
`pathway— the β -adrenergic receptor (AR) pathway.
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`3
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`•
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`•
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`Overactive bladder (OAB) is characterized by involuntary contraction of the detrusor muscle during the
`storage phase.
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`Myrbetriq relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by
`activation of the β -AR.
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`3
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`As a result, bladder capacity is increased.
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`•
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`Mirabegron is an agonist of the human β -AR as demonstrated by in vitro laboratory experiments using the cloned
`human β -AR.
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`1
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`https://www.myrbetriqhcp.com/isi/
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`2/4/2018
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`ASTELLAS 2003
`Sawai v. Astellas
`IPR2018-00079
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`

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`Important Safety Information
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`Page 2 of 6
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`•
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`1
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`3
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`Although mirabegron showed very low intrinsic activity for cloned human β -AR and β -AR, results in humans
`indicate that β -AR stimulation occurred at a mirabegron dose of 200 mg.
`See how Myrbetriq targets the β -AR pathway.
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`1
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`your patients? Submit your
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`overactive bladder (OAB)
`for your patients.
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`Important Safety Information
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`Page 3 of 6
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`latest information from
`Astellas Urology.
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`‡
`
`Subject to eligiblity. Restrictions may apply.
`
`Behavioral therapies may be combined with pharmacologic management as a first-line
`treatment option for OAB, according to AUA/SUFU guidelines
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`4
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`Adapted from AUA/SUFU (American Urological Association/Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction)
`guidelines.
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`Efficacy Summary
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`Study Design1
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`Efficacy evaluated in three 12-week, double-blind,
`placebo-controlled Phase III studies1
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`Safety Profile
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`Safety evaluated in three 12-week, double-blind,
`placebo-controlled Phase III studies **1
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`Safety evaluated in a 1-year, randomized, fixed-dose,
`double-blind, active-controlled study1††
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`expand
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`Important Safety Information
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`Page 4 of 6
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`**In Studies 1, 2, and 3, Myrbetriq was evaluated for safety in 2736 patients. Study 1 also included an active control. For the combined Studies 1,
`2, and 3, 432 patients received Myrbetriq 25 mg, 1375 received Myrbetriq 50 mg, and 929 received Myrbetriq 100 mg once daily.
`††
`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.
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`Dosing
`
`Convenient, once-daily oral therapy
`
`®
`The recommended starting dose of Myrbetriq  (mirabegron)
`1
`is 25 mg orally, once daily
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`Myrbetriq 25 mg can be effective within 8 weeks.
`1
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`Based on individual patient efficacy and tolerability, the dose may be increased to 50 mg, once daily.
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`1
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`Myrbetriq can be taken with or without food.
`1
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`Myrbetriq should be taken with water, swallowed whole, and should not be chewed, divided, or crushed.
`1
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`There is no generic equivalent
`to Myrbetriq
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`Dose adjustments in special populations1
`•
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`The daily dose of Myrbetriq should not exceed 25 mg once daily in the following populations:
`-
`Patients with severe renal impairment (CL 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m ).
`2
`cr
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`Patients with moderate hepatic impairment (Child-Pugh Class B).
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`Important Safety Information
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`Page 5 of 6
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`Myrbetriq is not recommended for use in patients with end-stage renal disease (ESRD) or in patients with severe
`hepatic impairment (Child-Pugh Class C).
`No dose adjustment is necessary for the elderly.
`The safety and effectiveness of Myrbetriq in pediatric patients have not been established.
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`•
`•
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`INDICATIONS AND USAGE
`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.
`
`IMPORTANT SAFETY INFORMATION
`Myrbetriq is contraindicated 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).
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`Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for
`the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A controlled
`clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients;
`however, Myrbetriq should be administered with caution to patients with clinically significant BOO. Myrbetriq should
`also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB.
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`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. 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 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%).
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`In postmarketing experience, the following events have also occurred: constipation, diarrhea, and dizziness.
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`Please see accompanying complete Prescribing Information for Myrbetriq (mirabegron)
`®
`
`REFERENCES
`
`1. Myrbetriq [Prescribing Information]. Northbrook, IL: Astellas Pharma US, Inc. 2. Astellas Pharma US, Inc. Data on
`File. 3. Chu FM, Dmochowski R. Pathophysiology of overactive bladder. Am J Med. 2006;119(3):3S-8S. 4. Gormley
`EA, Lightner DJ, Burgio KL, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults:
`AUA/SUFU guideline. Linthicum, MD: American Urological Association Education and Research, Inc.; 2014:1-57.
`5. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β -adrenoceptor agonist, in
`3
`patients with overactive bladder: results from a randomised European–Australian phase 3 trial. Eur Urol.
`2013;63:283-295.
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`https://www.myrbetriqhcp.com/isi/
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`2/4/2018
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`Important Safety Information
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`Page 6 of 6
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`1-800-477-6472 or go to www.astellaspharmasupportsolutions.com.
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