www.myrbetriqhcp.com Open in urlscan Pro
40.121.16.193  Public Scan

Form analysis
0 forms found in the DOM

Text Content

 * Full Prescribing Information
 * Important Safety Information
 * Urology Resources
 * Patient Site
 * Request a Rep

Menu
 * Home
 * Mechanism
   of Action
 * Efficacy
   * Study Design
   * Efficacy Results
   * Adults ≥65 (PILLAR):
     Study Design
   * Adults ≥65 (PILLAR):
     Efficacy Results
 * Safety
   * Safety Results
   * Adults ≥65 (PILLAR):
     Safety Results
 * Dosing &
   Administration
   * Dosing
   * Drug-to-Drug Interactions
 * Combination
   Treatment
   * MOA
   * Combination Therapy
   * Add-on Therapy
   * Safety
   * Dosing
 * Support
   * Patient Support
   * Savings & Support
   * Physician Support

 * Full Prescribing Information
 * Important Safety Information
 * Urology Resources
 * Patient Site
 * Request a Rep

Request Samples
Study Design
Efficacy Results
Adults ≥65 (PILLAR): Study Design
Adults ≥65 (PILLAR): Efficacy Results
Safety Results
Adults ≥65 (PILLAR): Safety Results
Dosing
Drug-to-Drug Interactions
MOA
Combination Therapy
Add-on Therapy
Safety
Dosing
Patient Resources
Savings & Support
Physician Resources
Safety and efficacy
Medicare Part D coverage
Previous section
Mechanism of Action

Next section
Safety


Efficacy


GO WITH EFFICACY FOR INCONTINENCE
AND MICTURITION FREQUENCY1


STUDY DESIGN: MONOTHERAPY

Myrbetriq was evaluated in three 12‑week, double‑blind, randomized,
placebo‑controlled, parallel‑group, multicenter clinical trials in adult
patients with overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency, and urinary frequency (Studies 1, 2, and 3).

ENTRY CRITERIA

 * OAB symptoms for ≥3 months
 * ≥8 micturitions per day
 * ≥3 episodes of urgency with or without incontinence over a 3 day period

EFFICACY ENDPOINTS IN STUDIES 1, 2, AND 3

Change from baseline to end of treatment (Week 12) in:

 * Mean number of incontinence episodes per 24 hours (co‑primary)
 * Mean number of micturitions
   per 24 hours, based on a 3 day micturition diary (co‑primary)
 * Mean volume voided per micturition (secondary)




CLINICAL STUDIES: MONOTHERAPY

EFFICACY DEMONSTRATED IN THREE 12-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED
PHASE III STUDIES1

Fewer episodes of
incontinence

Reduced micturition
frequency

Greater volume
voided

Reduced Incontinence


MYRBETRIQ SIGNIFICANTLY REDUCED INCONTINENCE EPISODES PER 24 HOURS1

CO-PRIMARY ENDPOINT

Mean change from baseline to end treatment (Week 12) in number of incontinence
episodes per 24 hours (Full Analysis Set-Incontinence [FAS-I])1-5*†‡

 * Study 1
 * Study 2
 * Study 3


Study 1 - View More Data

Study 2 - View More Data

Study 3 - View More Data

MYRBETRIQ WAS EFFECTIVE IN TREATING THE SYMPTOMS OF OVERACTIVE BLADDER (OAB):

 * Myrbetriq 25 mg: Within 8 weeks
 * Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week
treatment period.1

*For incontinence episodes per 24 hours, the analysis population is restricted
to patients with ≥1 episode of incontinence at baseline.
†Adjusted mean for baseline, gender, and geographic region.
‡This population includes patients randomized to placebo and Myrbetriq 50 mg in
Studies 1 and 2.
§Statistically significant vs placebo at the 0.05 level with multiplicity
adjustment.

Reduced Micturition Frequency


MYRBETRIQ SIGNIFICANTLY REDUCED MICTURITION FREQUENCY PER 24 HOURS1

CO-PRIMARY ENDPOINT

Mean change from baseline to end of treatment (Week 12) in number of
micturitions per 24 hours1-5*

 * Study 1
 * Study 2
 * Study 3


Study 1 - View More Data

Study 2 - View More Data

Study 3 - View More Data

MYRBETRIQ WAS EFFECTIVE IN TREATING THE SYMPTOMS OF OVERACTIVE BLADDER (OAB):

 * Myrbetriq 25 mg: Within 8 weeks
 * Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week
treatment period.1

*Adjusted mean for baseline, gender, and geographic region.
†Statistically significant vs placebo at the 0.05 level with multiplicity
adjustment.

Increased Volume Voided


MYRBETRIQ INCREASED THE MEAN VOLUME OF URINE VOIDED PER MICTURITION1

SECONDARY ENDPOINT

Mean change from baseline to end of treatment (Week 12) in volume of urine (mL)
voided per micturition1-5*

 * Study 1
 * Study 2
 * Study 3



*Adjusted mean for baseline, gender, and geographic region.
†Statistically significant vs placebo at the 0.05 level with multiplicity
adjustment.
‡Myrbetriq 25 mg did not demonstrate statistical significance for change in
volume voided per micturition.


ELDERLY PATIENT SUBGROUP ANALYSIS

OVERACTIVE BLADDER (OAB) PREVALENCE

 * The prevalence of OAB symptoms increases with age in both men and women6
 * OAB has a prevalence of ~15% among those aged ≥65 and 30–40% among those aged
   ≥757

MYRBETRIQ MONOTHERAPY IN ELDERLY PATIENT POPULATIONS

 * 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 younger
   volunteers1†

*Of 5648 patients who received Myrbetriq monotherapy in the Phase II and III
studies for OAB, 2029 (35.9%) were 65 years of age or older, and 557 (9.9%) were
75 years of age or older. All patients were ≥18 years of age.1

†The Cmax and area under curve (AUC) of Myrbetriq following multiple oral doses
in elderly volunteers (≥65 years) were similar to those in younger volunteers
(18 to 45 years).1

To see the safety results, including a subset analysis of elderly patients,
click here


STUDY DESIGN: PILLAR, THE FIRST PROSPECTIVE STUDY OF MYRBETRIQ IN ADULTS ≥65

EFFICACY DEMONSTRATED IN A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,
PARALLEL-GROUP, MULTICENTER PHASE IV STUDY8

ENTRY CRITERIA

 * Male and female community-dwelling patients ≥65 years of age
 * Wet OAB symptoms (defined as urgency, urinary frequency, and urinary
   incontinence) for ≥3 months
 * ≥8 micturition episodes per 24 hours
 * ≥3 urgency episodes
 * ≥1 urinary incontinence episode

EFFICACY ENDPOINTS

 * Co-primary Endpoint: Change from baseline to end of treatment (EoT) in the
   mean number of urinary incontinence episodes per 24 hours
 * Co-primary Endpoint: Change from baseline to EoT in the mean number of
   micturitions per 24 hours
 * Secondary Endpoint: Change from baseline to EoT in mean volume voided per
   micturition

TREATMENT ARMS AND TIMELINE

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.

EoT = End of Treatment


PILLAR EFFICACY RESULTS

Reduced Incontinence


MYRBETRIQ SIGNIFICANTLY REDUCED THE MEAN NUMBER OF INCONTINENCE EPISODES PER 24
HOURS IN PATIENTS ≥65 YEARS OF AGE8

CO-PRIMARY ENDPOINT

Change from baseline to end of treatment (EoT) in mean number of urinary
incontinence episodes per 24 hours8

 * 38% of elderly patients receiving Myrbetriq achieved zero incontinence vs 30%
   in the placebo group (OR 1.50, 95% CI 1.09, 2.06).


 * 38% of elderly patients receiving Myrbetriq achieved zero incontinence vs 30%
   in the placebo group (OR 1.50, 95% CI 1.09, 2.06).

Reduced Micturition Frequency


MYRBETRIQ SIGNIFICANTLY REDUCED THE MEAN NUMBER OF MICTURITIONS PER 24 HOURS IN
PATIENTS ≥65 YEARS OF AGE8

CO-PRIMARY ENDPOINT

Change from baseline to EoT in the mean number of micturitions per 24 hours8



Increased Volume Voided


MYRBETRIQ INCREASED THE MEAN VOLUME OF URINE VOIDED PER MICTURITION IN PATIENTS
≥65 YEARS OF AGE8

SECONDARY ENDPOINT

Change from baseline to EoT in mean volume voided per micturition8



To see PILLAR safety results in patients ≥65 years of age, click here


INTERESTED IN LEARNING MORE?

You can request a visit from one of our sales representatives to learn more
about Myrbetriq.

Submit your request here
Previous section
Mechanism
of Action
Next section
Safety


STUDY 1 – INCONTINENCE DATA

Mean change from baseline in mean number of incontinence episodes per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.


STUDY 2 – INCONTINENCE DATA

Mean change from baseline in mean number of incontinence episodes per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.


STUDY 3 – INCONTINENCE DATA

Mean change from baseline in mean number of incontinence episodes per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.


STUDY 1 – MICTURITION FREQUENCY DATA

Mean change from baseline in mean number of micturitions per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.


STUDY 2 – MICTURITION FREQUENCY DATA

Mean change from baseline in mean number of micturitions per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.


STUDY 3 – MICTURITION FREQUENCY DATA

Mean change from baseline in mean number of micturitions per 24 hours1*

*Efficacy statements cannot be derived from this analysis and can only be made
from the ANCOVA analysis of the co‑primary endpoints at final visit.

Important Safety Information,
Indications and Usage

Show more Show less
Show less

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.

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(2):283-95. 3. Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M,
Herschorn S. Results of a randomized phase III trial of mirabegron in patients
with overactive bladder. J Urol 2013;189(4):1388-95. 4. Astellas. Myrbetriq.
Data on File. 5. Herschorn S, Barkin J, Castro-Diaz D, et al. A phase III,
randomized, double-blind, parallel-group, placebo-controlled, multicentre study
to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in
patients with symptoms of overactive bladder. Urology 2013;82(2):313-20. Erratum
in: Urology 2013;82(6):1457. 6. Coyne KS, Sexton CC, Vats V, Thompson C, Kopp
ZS, Milsom I. National community prevalence of overactive bladder in the United
States stratified by sex and age. Urology 2011;77(5):1081-7. 7. 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. 8. 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.

 * Home
 * Mechanism
   of Action
 * Efficacy
   * Study Design
   * Efficacy Results
   * Adults ≥65 (PILLAR):
     Study Design
   * Adults ≥65 (PILLAR):
     Efficacy Results
 * Safety
   * Safety Results
   * Adults ≥65 (PILLAR):
     Safety Results
 * Dosing &
   Administration
   * Dosing
   * Drug-to-Drug Interactions
 * Combination
   Treatment
   * MOA
   * Combination Therapy
   * Add-on Therapy
   * Safety
   * Dosing
 * Support
   * Patient Support
   * Savings & Support
   * Physician Support

To learn more about patient assistance programs for Myrbetriq, please call
Astellas Pharma Support SolutionsSM at 1‑800‑477‑6472 or go to
www.astellaspharmasupportsolutions.com.

Myrbetriq, VESIcare, Astellas, and the flying star logo are registered
trademarks of Astellas Pharma, Inc. All other trademarks or registered
trademarks are the property of their respective owners.

This site is intended for US Healthcare Professionals only.
©2021 Astellas Pharma US, Inc.

055-0331-PM

 * Privacy Policy
 * Legal Disclaimer
 * Request a Rep
 * Contact Us
 * Medical Information

The information contained on this site is intended for
healthcare professionals in the United States only.
It is not intended for the general public.

I AM a US healthcare professional I am NOT a US healthcare professional
×


YOU ARE NOW LEAVING MYRBETRIQHCP.COM

You are now leaving myrbetriqhcp.com. The website you are linking to is neither
owned nor controlled by Astellas. Astellas is not responsible for the content or
services on the site.

Continue to Twitter.

Continue Cancel

This website is funded and developed by Astellas Pharma US, Inc. Myrbetriq is a
registered trademark of Astellas Pharma Inc.


YOU ARE NOW LEAVING MYRBETRIQHCP.COM

By clicking “Continue,” you will leave MyrbetriqHCP.com and enter
astellasmedinfo.com. The information contained on Astellas Medical Information
is intended for U.S. healthcare professionals only.

Continue Cancel

This website is funded and developed by Astellas Pharma US, Inc. Myrbetriq is a
registered trademark of Astellas Pharma Inc.


ELIGIBILITY RESTRICTIONS, TERMS & CONDITIONS

TO THE PATIENT: This offer is not valid for patients whose prescription claims
are reimbursed, in whole or in part, by any state or federal government program,
including, but not limited to, Medicaid, Medicare, Medigap, Department of
Defense (DoD), Veterans Affairs (VA), TRICARE, CHAMPUS, Puerto Rico Government
Health Insurance, or any State Patient or Pharmaceutical Assistance Program.
This offer is void where prohibited by law. Certain rules and restrictions
apply.

Note: If you use a mail-order pharmacy, please contact your pharmacy provider to
ensure that this offer will be accepted. If the mail-order pharmacy will not
process your voucher, please call 1‑866‑666‑8244 (Monday-Friday, 8 a.m.-8 p.m.
ET, excluding holidays) and request to speak to an agent. An agent will mail a
Direct Member Reimbursement (DMR) form to you. The form should be completed and
returned to the address on the form, along with your pharmacy receipt. If you
are eligible, you will receive your benefit in the mail. You can also visit
www.patientrebateonline.com to obtain a DMR form.

TO THE PHARMACIST: By redeeming this coupon, I certify that (i) I have received
this coupon from an eligible patient, (ii) I have dispensed the products
indicated, (iii) I have not submitted, and will not submit, a claim for
reimbursement to Part D of Medicare, Medicaid, or any similar federal or state
program, including a state pharmaceutical assistance program, and (iv) I will
otherwise comply with the terms hereof.

I further certify that my participation in this program is consistent with all
applicable state laws and any obligations, contractual or otherwise, that I have
as a pharmacy provider. Please submit the amount of co‑pay authorized by the
patient's primary insurance as a secondary transaction to McKesson. For pharmacy
processing assistance or questions, please call the Help Desk at 1-866-666-8244.

HOURS OF OPERATION: Monday-Friday, 8 a.m.-8 p.m. ET, excluding holidays.

Astellas reserves the right to rescind, revoke, or amend this offer without
notice. This program is not insurance.



Important Safety Information,
Indications and Usage

Show more Show less
Show less

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.

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)