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PROVEN RESULTS WITH GEMTESA

Significant improvement in overactive bladder (OAB) symptom relief at 12 weeks

In a 12-week clinical study:

People taking GEMTESA had 2 fewer daily leakage episodes compared with about 1 (-1.4) fewer episode for those taking placebo.*

People taking GEMTESA had nearly 2 (-1.8) fewer bathroom visits per day compared with about 1 (-1.3) fewer visit per day for those taking placebo.

People taking GEMTESA had nearly 3 (2.7) fewer bathroom visits with "urge to go" feelings compared with 2 fewer visits for those taking placebo.

Additional clinical study results seen at 12 weeks:

About half (52%) of people taking GEMTESA saw a 75% or greater reduction in daily leakage episodes vs 37% for people taking placebo.*

*403 people received GEMTESA and 405 people received placebo.

526 people received GEMTESA and 520 people received placebo.

Listen to Kate, a patient with overactive bladder, talk about her GEMTESA experience

“I spend less time preparing for my symptoms, and that includes stocking up on pads.”

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

Transcript

I'm less concerned about my symptoms now that I'm taking GEMTESA for my overactive bladder, OAB.”

[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.

More Than My OAB: Kate's GEMTESA Journey

OAB Won't Define Me

Running water used to trigger my OAB symptoms. I remember taking my dog for a walk on the beach and when I got home, I had to hose the sand off my feet, and I could not believe that I didn't have to run to the bathroom.”

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

I spend less time preparing for my symptoms, and that includes stocking up on pads.

 

I'm not married to the bathroom anymore.”

[Text on screen] Individual results may vary.

When I opened up about my story, I never realized how women want to talk about this issue.

 

My positive experience with GEMTESA has motivated other people to seek help.

 

I encourage them not to suffer in silence.

 

OAB symptoms can be overwhelming, but there is a treatment that may help.

 

My doctor explained to me the possible side effects and those included a headache or common cold symptoms, but for me I was ready to start treatment.”

[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.

If you're dealing with bothersome OAB symptoms, there's a treatment that may help.

Ask a healthcare professional about GEMTESA today.

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

You may pay as little as $0 for each 90-day supply of GEMTESA with the Simple Savings Program!

Limited time offer is valid from January 1, 2023 through December 31, 2024. Restrictions and maximum savings limits apply. Coverage and out-of-pocket costs may vary. Offer not valid for patients participating in Medicare, Medicaid, or other government healthcare programs. See Program Terms, Conditions, and Eligibility Criteria.

 

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