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GET TO KNOW OVERACTIVE BLADDER (OAB) AND HOW GEMTESA WORKS

How does your bladder work?

As your bladder fills, nerve signals in your brain trigger your need to urinate. These signals tell your bladder to:

  • Relax the muscles of the pelvic floor and urethra
  • Contract (squeeze) the muscles in the bladder to release urine

However, when you're living with OAB, your bladder muscles may suddenly contract too frequently and too often, even when your bladder isn't full, creating an urgent feeling that you need to urinate.

How does GEMTESA work?

  • GEMTESA is a type of medication called a “beta-3 agonist,” which is designed to help relax your bladder muscle so it can hold more urine
  • This may help to reduce the urgent need to run to the bathroom and the number of leakages you may experience
M3 (muscarinic)
receptorβ3 receptorDiagram of a bladder. GEMTESA® activates the beta-3 adrenergic receptor, relaxing the bladder detrusor muscle.

For illustrative purposes only.

Listen to Kate, a patient with overactive bladder, talk about her doctor's explanation of how GEMTESA works

“

So my doctor explained to me that GEMTESA could help reduce my OAB symptoms based on clinical trials.”

–

Kate, a real GEMTESA patient who has been compensated for her participation in this video

Transcript

“

After I shared with my doctor my overactive bladder, or OAB, symptoms, she recommended that I try GEMTESA.”

[Text on screen] GEMTESA is a prescription medication for the treatment of overactive bladder (OAB) in adults with symptoms of leakage episodes, urgency, and frequency. Please see Important Safety Information at the end of this video.

More Than My OAB: Kate's GEMTESA Journey

Beginning My GEMTESA Journey

Kate is a real patient taking GEMTESA who has been compensated by Urovant Sciences for her participation in this video.

“

So my doctor explained to me that GEMTESA could help reduce my OAB symptoms based on clinical trials.”

[Text on screen] GEMTESA may help some patients reduce leakage episodes, frequency, and urgency. GEMTESA may not be for everyone.

“

She also talked to me about possible side effects, and those could include headache or common cold symptoms.

 

But I was ready to take that next step.”

[Text on screen] Side effects may include headache, common cold symptoms, diarrhea, nausea, urinary tract and upper respiratory tract infection. Please see Important Safety Information at the end of this video.

“

When I got home, I took that first dose immediately. The bottle sits on my counter; it's very convenient for my lifestyle. And I even have it on my calendar.”

[Text on screen] GEMTESA should be taken once daily with or without food and swallowed whole with a glass of water.

“

After I started taking GEMTESA I remember running an errand, and getting home and putting my key in the lock of my door, and I could not believe that I didn't have to run to the bathroom.”

[Text on screen] Key-in-lock syndrome is a sudden, uncontrollable urge to go to the bathroom as soon as you get home.

“

My OAB symptoms were definitely preventing me from doing the things that I dearly love.

 

But now with GEMTESA, I can navigate my OAB symptoms much better.”

[Text on screen] Ready to take the next step in managing OAB?

Ask a healthcare professional if GEMTESA is right for you.

Do not take if you have a known allergic reaction to GEMTESA or its ingredients. Tell your doctor right away if you are unable to empty your bladder or if you have a weak urine stream.

[Text on screen] GEMTESA may increase your chances of not being able to empty your bladder.

Tell your doctor if you are taking medicines that contain digoxin, or if you have liver or kidney problems.

Side effects may include headache, common cold symptoms, diarrhea, nausea, urinary tract and upper respiratory tract infection.

[Text on screen] Available by prescription only. Call 1-833-UROVANT.

Full Product Information can be found at GEMTESA.com/PI

Learn about getting started with GEMTESA, and how easy it is to stay on track

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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 and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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 and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

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.

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

Sumitomo Pharma logo.

is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

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

©2024 Sumitomo Pharma America, Inc. All rights reserved. US-VBGN-2000042 (v9.0) 04/24

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information.

What is GEMTESA?

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

  • urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • urgency: the need to urinate right away
  • frequency: urinating often

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information.

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

Sumitomo Pharma logo.

is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

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

©2024 Sumitomo Pharma America, Inc. All rights reserved. US-VBGN-2000043 (v10.0) 03/24