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 * 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

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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
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Mechanism
of Action


It’s time to reduce her overactive bladder (OAB) symptoms


SHE HAS PLACES TO GO.

For your adult patients with symptoms of OAB, Myrbetriq offers meaningful
reductions in urge urinary incontinence, urgency, and urinary frequency1

See How Myrbetriq Works


MYRBETRIQ IS THE #1 PRESCRIBED BRANDED OAB MEDICATION2*

*Based on 24-month TRx shares for all OAB medications, IMS Health National
Prescription Audit, January 2019—December 2020.

THIS INFORMATION DOES NOT IMPLY SAFETY OR EFFICACY OF ANY PRODUCT; NO
COMPARISONS SHOULD BE MADE.

EVALUATED IN ADULTS ≥65 YEARS OLD3

PILLAR is the first prospective study of Myrbetriq in adults ≥65

See Study Results

THE FEDERAL AVIATION ADMINISTRATION (FAA) ACCEPTS MYRBETRIQ FOR OAB TREATMENT4

View Safety Profile
Next section
Mechanism of Action

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. Astellas. Myrbetriq. Data on File. 3. 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.
4. Federal Aviation Administration. Federal Air Surgeon's Medical Bulletin.
Oklahoma City, OK: Federal Aviation Administration. 2013‑2014;51(4):1-14.

 * 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 055-0370-PM

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healthcare professionals in the United States only.
It is not intended for the general public.

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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)