Full Prescribing Information
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GEMTESA is a prescription medication for the treatment of overactive bladder (OAB) in adults with symptoms of leakage episodes, urgency, and frequency.
GEMTESA patient support
We’re here to help you navigate your GEMTESA journey — from taking your first dose to preparing for your follow-up appointment with your doctor.

GPS pin Start here to learn how to make the most of your treatment journey with GEMTESA Patient Support (GPS).

Tesa, Martha, and Lori driving

GETTING STARTED

It’s time to take your
first dose of GEMTESA

Taking your prescription daily is important for a chronic — yet treatable — condition like overactive bladder (OAB). Make sure you follow your prescription instructions and talk to your doctor about your GEMTESA treatment routine.

There's only one GEMTESA and no generic substitute.

When you fill your prescription, make sure you receive GEMTESA.

GEMTESA® pill bottle
Once-daily dosing
GEMTESA should be taken every day with or without food.

*Tablet not actual size

One single-dose pill*
Swallow GEMTESA tablet whole with a glass of water.
Crushable, if needed
In adults, GEMTESA tablets may be crushed, mixed with about a tablespoon of applesauce and taken immediately with a glass of water.

GETTING STARTED

In a clinical trial, most people taking GEMTESA saw results at 12 weeks of consistent use as prescribed.

Remember: OAB is chronic and doesn’t go away, but may be managed as long as you have a treatment plan.

People taking GEMTESA had 2 fewer daily leakage episodes compared with about 1 (-1.4) fewer episodes for those taking placebo.*
People taking GEMTESA had nearly 2 (-1.8) fewer bathroom visits per day compared with about 1 (-1.3) fewer visits 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.†
The efficacy and safety of GEMTESA were studied in a 12-week trial of people with symptoms of OAB (urge urinary incontinence, urgency, frequency).

*403 people received GEMTESA, and 405 people received placebo.

†526 people received GEMTESA, and 520 people received placebo.

GETTING STARTED

Safety at 52 weeks on GEMTESA

Remember: OAB is chronic and doesn’t go away. In a long-term study, some people chose to stay on GEMTESA for up to 1 year to manage their OAB symptoms. Just make sure you’re checking in with your doctor on a regular basis to make sure your treatment plan is working best for you.

At 1 year on GEMTESA*:

In addition to side effects seen at 12 weeks, patients also reported urinary tract infection and bronchitis. Most people found GEMTESA to be tolerable with no major impact on hypertension. At 52 weeks, people taking GEMTESA and those taking active control had similar rates of hypertension (8.8% vs 8.6%, respectively).
At 52 weeks, 98.5% of people taking GEMTESA did not stop due to side effects.
Most people saw symptom relief at 52 weeks.
In a clinical study, safety was demonstrated for up to 52 weeks in people with symptoms of OAB (urge urinary incontinence, urgency, frequency).

*273 people received GEMTESA, and 232 people received an active
control (a known, effective treatment, unlike a placebo/sugar pill).

GETTING STARTED

Side effects

Like any medication, GEMTESA may cause side effects. If you notice any of these, speak with your doctor about what you should do.

GEMTESA may cause serious side effects such as:
  • •Increasing your chances of not being able to empty your bladder.
  • •An allergic reaction with swelling of the lips, face, tongue or throat, with or without difficulty breathing.
Stop using GEMTESA and tell your doctor right away if you experience these symptoms.
The most common side effects of GEMTESA are headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection.
GEMTESA had no significant impact on blood pressure. At 12 weeks, people taking GEMTESA and those taking placebo had similar rates of hypertension (1.7% vs 1.7%, respectively) and increased blood pressure (0.7% vs 0.9%, respectively).
Less than 2% of people stopped taking GEMTESA because of side effects.
GEMTESA is the only OAB treatment of its kind* with no blood pressure warning in its label

*In the beta3-agonist category.

GETTING STARTED

Print the Let’s Go Tracker and follow-up discussion guide

This tracker may help you set personal treatment goals and keep track of any progress. Staying on track is especially important for managing chronic conditions that don’t go away, like OAB.

Download the printable tracker now for:

Lifestyle tips to help manage your OAB symptoms
Activities to set your personal and treatment goals
Tracker sheets to show your progress with GEMTESA
Follow-up questions for your doctor
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Car
Let's Go Tracker download

Reminder to download the Let's Go Tracker and questions to ask your doctor at your next appointment

DOWNLOAD TRACKER
Martha holding phone
Martha with pill and water

COSTS & COVERAGE

If you have commercial insurance, the GEMTESA SIMPLE SAVINGS PROGRAM* is here to help eligible patients qualify for potential savings to lower out-of-pocket costs. This offer is only valid through December 31, 2025, so see if you qualify now!

Eligible, commercially insured patients may pay as little as $0 for a 90-day fill with the GEMTESA SIMPLE SAVINGS PROGRAM. That means you’ll only need to refill 4 times per year. Government plans like Medicare or Medicaid are not eligible.*

Have Medicare, Medicaid, or another government plan? You may be covered through your plan. Just contact your provider to see if you’re eligible.

Martha holding phone
Martha with pill and water

Get Your GEMTESA Simple Savings Card

Click here to apply or activate your savings card.

APPLY

Text† “GEMTESA” to 436872

  • Fill out and submit your enrollment form
  • If eligible, your savings card information will be texted to your phone. Bring this information to the pharmacy when picking up your GEMTESA prescription

*Restrictions and maximum saving limits apply. Coverage and out-of-pocket costs may vary. Offer not valid for patients participating in Medicare, Medicaid, or other government healthcare programs.  Program Terms, Conditions, and Eligibility Criteria

†Message and data rates may apply. Up to 15 messages per month after initial sign-up communications. Text STOP to unsubscribe at any time.

Did you know? Access to GEMTESA is expanding with more predictable costs for Medicare Part D enrollees.
Contact your insurance or Part D plan for more details.

Tesa on her phoneTesa on her phone
Sign up to take advantage of support resources and convenient refill reminders!

HEAR FROM OTHERS

Like any new journey, it can be comforting to know that others have blazed the trail before you. GEMTESA Go-Getters — like Holly Robinson Peete — challenged themselves to prioritize their bladder health and seek treatment for bothersome OAB symptoms, and they hope to encourage others to do the same. These real go-getters stuck to their treatment plans long-term and have continued to manage their symptoms with the help of GEMTESA, allowing them to focus more on what they love and less on worrying about the bathroom. Hear their stories below.

Holly Robinson Peete, actor and GEMTESA® spokesperson

I had to be consistent in taking GEMTESA to see results since OAB is a chronic condition and doesn't actually go away.

Holly Robinson Peete's signature

Actor, real OAB patient, and GEMTESA spokesperson.

Individual results may vary.

HEAR FROM OTHERS

Like any new journey, it can be comforting to know that others have blazed the trail before you. GEMTESA Go-Getters — like Holly Robinson Peete — challenged themselves to prioritize their bladder health and seek treatment for bothersome OAB symptoms, and they hope to encourage others to do the same. These real go-getters stuck to their treatment plans long-term and have continued to manage their symptoms with the help of GEMTESA, allowing them to focus more on what they love and less on worrying about the bathroom. Hear their stories below.

Diane, a patient

There are no overnight fixes. You have to be consistent with taking GEMTESA to see results. I’ve been on GEMTESA for 3 years now, and I can’t imagine going back.

Diane's name

Diane is a real patient taking GEMTESA who has been compensated for her participation.

Individual results may vary.

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Car
Let's Go tracker Download

Reminder to download the Let's Go Tracker and questions to ask your doctor at your next appointment

DOWNLOAD TRACKER
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Car
GEMTESA patient brochure download, English

Patient Brochure — English

Download this brochure with educational information about OAB and GEMTESA for the treatment of overactive bladder.

DOWNLOAD PDF
GEMTESA patient brochure download, Spanish

Patient Brochure — Español

Obtenga más información sobre la vejiga hiperactiva y GEMTESA para el tratamiento de la vejiga hiperactiva.

DESCARGAR PDF
Open Important Safety 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:

  • 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.
  • angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing. Stop using GEMTESA and tell your doctor right away.

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:

  • 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.
  • angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing. Stop using GEMTESA and tell your doctor right away.

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 icon 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.

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