ARE YOU LIVING WITH
OVERACTIVE BLADDER (OAB)?

Bring these results to your OAB treatment provider to see
if you could have OAB

It’s important to talk with your OAB treatment provider about your symptoms. Many people think OAB is an acceptable
part of aging, but it doesn’t have to be. Living with OAB can be disruptive, but together you and your OAB treatment
provider can work on a treatment to help manage your symptoms.

  1. 1. How many times do you urinate during the day? (Frequency)

    No Response

  2. 2. How often do you have a strong, sudden urge to urinate which makes you feel like you will leak if you don't get to a bathroom immediately? (Urgency)

    No Response

  3. 3. How often do you leak after feeling a strong urge to go? (Urge urinary incontinence)

    No Response

  4. 4. How much do these symptoms bother you?

    No Response

  5. 5. Do you take any medications for high blood pressure, depression, or diabetes?

    No Response

  6. 6. Have you ever canceled trips, avoided exercising, or refused invitations because you weren't sure you'd be close to a bathroom?

    No Response

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.

Please see next page for Important Safety Information

Talk to your provider about
More Time Here, Less Time There

Questions to ask about treatment

If you have been diagnosed with OAB, you and your OAB treatment provider
may decide to start treatment. Here are some questions about treatment to
talk over with an OAB treatment provider:

  • What are my treatment options for OAB?
  • How often do I need to take this medication?
  • What side effects can I expect?
  • Will this treatment work well with other medications?

OAB symptoms can be embarrassing, but there’s a treatment that may help.

Ask your provider if GEMTESA could be right for you!

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 attached Summary of Information about GEMTESA.

SMPA logois 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.
©2023 Sumitomo Pharma America, Inc. All rights reserved. US-VBGN-2000043 (V9.0) 11/23
GEMTESA

(gem-tes-ah)

IMPORTANT INFORMATION

This is a summary of information about GEMTESA. This does not take the place of talking with your doctor about your medical condition or treatment.

What is GEMTESA?

GEMTESA is a prescription medicine for adults that
can be used to treat the following symptoms of
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.

Who should not take GEMTESA?

  • Do not take GEMTESA if you are allergic to vibegron
    or any of the ingredients in GEMTESA
    • Active ingredient: vibegron
    • Inactive ingredients: croscarmellose sodium,
      hydroxypropyl cellulose, magnesium stearate,
      mannitol, and microcrystalline cellulose.
      The light green film coating contains FD&C Blue
      No. 2 - aluminum lake, hypromellose, iron oxide yellow,
      lactose monohydrate, titanium dioxide, and triacetin

What should I tell my doctor before
taking GEMTESA?

Before you take GEMTESA, tell your doctor about all of
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.

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
  • 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.

Is there any other important information I should know?

  • This is only a summary of the important information about
    GEMTESA. To learn more, talk with your healthcare
    provider or pharmacist
  • The FDA-approved product labeling can be found
    at GEMTESA.com
  • You may also report side effects to the FDA at
    1-800-FDA-1088