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SEE WHO MIGHT BENEFIT FROM GEMTESA

Meet Laura,* a patient who experiences urgency episodes

Age 53
Teacher
Not currently taking OAB medication
Laura, a patient who experiences urgency episodes.
My anxiety about finding a bathroom quickly is causing me to cancel plans and isolate myself.
*Not an actual patient

OAB Presentation and Impact

  • Persistent urgency episodes (3+ months) causing significant disruption in daily activities (work and personal)
  • Increased frequency and average of 3 daily urge urinary incontinence episodes have caused patient to limit water intake
  • Concerned about taking medications that impact existing hypertension
  • Increased anxiety due to fears about locating bathrooms in public settings

OAB Treatment Profile

  • Not previously treated with pharmacologic therapy
  • Currently using adult absorbent briefs

Comorbidities

  • Hypertension

Additional Medications

  • Metoprolol (metabolized by CYP2D6)1,2

Meet Allison,* a patient who experiences urge urinary incontinence (UUI)

Age 67
Social Worker
Previously treated with mirabegron
Allison, a patient who experiences urge urinary incontinence.
I'm constantly carrying pads and a change of clothes in case I can't make it in time.
*Not an actual patient

OAB Presentation and Impact

  • Suffering from urgency episodes for more than 1 year since stopping treatment
  • Increased depression due to coping with approximately 3 urge urinary incontinence episodes daily
  • Experiences frequent UTIs in addition to her OAB symptoms
  • Expresses interest in improving UUI symptoms

OAB Treatment Profile

  • Previous medication: mirabegron (50 mg, once daily)
      -
    •  Side effects: increased blood pressure, headache, UTIs, and nasopharyngitis3

Comorbidities

  • Depression
  • Type 2 diabetes
  • Hypertension
  • Dyslipidemia

Additional Medications

  • Fluoxetine
    (metabolized by CYP2D6)1,2,4
  • Metformin
  • Metoprolol
    (metabolized by CYP2D6)1,2
  • Rosuvastatin

CYP2D6=cytochrome P450 2D6; UTI=urinary tract infection.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has 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, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

 

INDICATIONS AND USAGE

GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of:

  • overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
  • overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has 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, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

References: 1. Hansten PD, Horn JR. The Top 100 Drug Interactions; A Guide to Patient Management. 2019 ed. Freeland, WA: H&H Publications, LLP; 2019. 2. Kobriger A. Drug Use in Long-Term Care (Effects on Nutrition & Health Status). OnCourse Learning; 2011:i-170. 3. Myrbetriq. Prescribing information. Astellas Pharma Inc; 2012. Revised 04/2021. 4. Meeks TW, Culberson JW, Horton MS. Medications in long-term care: when less is more. Clin Geriatr Med. 2011;27(2):171-191. doi:10.1016/j.cger.2011.01.003

You are encouraged to report side effects and product complaints associated with GEMTESA by calling 1-833-876-8268.

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GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

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