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What is GEMTESA?

GEMTESA is a prescription medication for the treatment of overactive bladder (OAB) in adults with symptoms of leakage episodes, urgency and frequency.

IMPORTANT SAFETY INFORMATION

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

Please see additional Important Safety Information throughout and enclosed Summary of Information about GEMTESA.

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.©2022 Urovant Sciences. US-VBGN-2000004 (v3.0) 03/22

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Text GEMTESA to 436872.

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Visit GEMTESA.COM/CARD

GET STARTED WITH “SIMPLE SAVINGS”Sign up for the GEMTESA Simple Savings Program today to take advantage of support resources to help you stay on track including: • Easy and convenient text and email messages

• Refill reminder message

• Motivational messages

DISCOVER GEMTESA

What is GEMTESA?GEMTESA is a prescription medication for the treatment of overactive bladder (OAB) in adults with symptoms of leakage episodes, urgency and frequency.

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


LESSTIMETHERE

MORETIMEHERE

LIVINGWITH

OVERACTIVEBLADDER

(OAB)?

Let’s start with what happens when you have OAB: OAB occurs when the bladder muscle contracts involuntarily.

These contractions cause symptoms like:

• Urgency: a sudden need to urinate that is difficult to control

• Frequency: urinating often

• Urge Urinary Incontinence: leakage episodes

WAITING FOR THE SUNSETONLY TO WAIT FOR THE STALL? Find out how a treatment option may help with disruptive OAB symptoms.

Scan the QR code with your smartphone camera to see how you can identify symptoms.

IMPORTANT SAFETY INFORMATION (CONT’D)

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);

2

OAB IS MORE COMMON THAN YOU THINKYOU ARE NOT ALONEMany people think OAB is an acceptable part of aging, but it doesn’t have to be. You can do something about it.

Approximately 1 in 10 Americans is impacted by

bothersome OAB symptomsThat’s about 33 million people.


are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about thebest way to feed your baby if you take GEMTESA).


4

LIVING WITH OAB SYMPTOMS OFTEN LEADS TO COPING BEHAVIOREver find yourself cutting activities short to deal with your OAB symptoms? If so, you're not alone.

Some common OAB coping techniques include:


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.

Scan the QR code with your smartphone camera to see why it might be time to find out more about OAB treatment.

Adjusting travel plans

Limiting exercise

Limiting activities


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.


Additional coping techniques that may be familiar to you:

• Wearing panty liners, pads, or diapers daily

• Packing extra supplies in case of an accident

• Mapping out the closest bathrooms

• Carefully planning your commute

6

At first, your primary care physician, urologist, or urogynecologist may offer you behavioral therapies, such as:• Bladder training

• Bladder-control strategies

• Pelvic-floor muscle training

Next, they may offera medical treatment, such as: • Beta3-agonist: a type of medication that can help

support the bladder’s ability to relax. For more information on how this type of medication can help to reduce OAB symptoms, see page 9

THINK COPING IS YOUR ONLY OPTION?

There are different ways to treat OAB, including medical treatment.


What are the possible side effects of GEMTESA? (CONT’D)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.

Remember, everyone is unique There is no single treatment that’s right for everyone. You may need to try several before finding one that works for you.

That’s why it’s important to keep an open dialogue with your OAB treatment provider. She or he can guide you toward finding ways to manage your OAB symptoms.


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


8

TREATING OAB WITH GEMTESA HAS ITS BENEFITS

NO SIGNIFICANT IMPACT ON BLOOD PRESSURE

No clinically significant changes to hypertension or increased bloodpressure vs placebo

PROVEN RESULTSSignificant reductions seen in all 3 key OAB symptoms* vs placebo (sugar pill) at 12 weeks—including urgencyUrgency episodes reduced by half in about 43% of people taking GEMTESA vs 38% of people taking placebo at 12 weeks



*Urgency, frequency, and leakage episodes.

One single-dose pill taken once daily with or without food. Swallow GEMTESA tablets whole with a glass of water

In adults, GEMTESA tablets may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water

A SIMPLE ROUTINE

HERE’S HOW GEMTESA WORKS

M3 (muscarinic) receptor

β3 receptor

GEMTESA is a type of medication called a “beta3-agonist,” which is designed to help relax your bladder muscle so it can hold more urine. This helps to reduce the need to run to the bathroom and the number of leakages that you may experience.

GEMTESA activates the beta3 receptors, allowing the bladder to relax:

GEMTESA has been proven in clinical trials to be effective and well-tolerated.

For illustrative purposes only.

Scan the QR code with your smartphone camera to explore how GEMTESA works.


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 willharm your unborn baby);


10

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.†

*403 people received GEMTESA and 405 people received placebo. †526 people received GEMTESA and 520 people received 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.†

Here are clinical study results seen at 12 weeks that you should know:


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).

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

Scan the QR code with your smartphone to see how GEMTESA can help.

SIGNIFICANT IMPROVEMENT IN OAB SYMPTOM RELIEF AT 12 WEEKS




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.*

12

ESTABLISHED SAFETY IN A CLINICAL STUDY AT 12 WEEKS


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.

GEMTESA had no signifi cant 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).

The most common side effects of GEMTESA at 12 weeks in a clinical trial were headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection.

Less than 2% of people stopped taking GEMTESA because of side effects.

Scan the QR code with your smartphone camera if you’re ready to fi nd out if GEMTESA is right for you, or visit GEMTESA.com to get started!

HOW TO START THE CONVERSATION WITH YOUR PROVIDER:

• Will GEMTESA work well with other medications?

• How does GEMTESA differ from other OAB treatments?

• Is GEMTESA clinically proven to reduce urgency?

• What side effects can I expect?

• How often do I need to take this medication?


What are the possible side effects of GEMTESA? (CONT’D)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.


14

IMPORTANT SAFETY INFORMATION (CONT'D)


ELIGIBLE PATIENTS SAVE MORE WITH A 90DAY SUPPLY OF GEMTESA

For a limited time, the GEMTESA SIMPLE SAVINGS PROGRAM is providing commercially insured patients with a savings offer to help them stay on track.

OFFER VALID OCTOBER 1, 2021 THROUGH DECEMBER 31, 2022

YOU MAY PAY AS LITTLE AS $10 FOR A 30DAY SUPPLY*

YOU MAY PAY AS LITTLE AS

OR

* 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 full program terms atGEMTESA.COM/CARD or at the end of the brochure.

For questions about this program, please call 1833UROVANT (8768268).

Same commercial insurance and coverage requirements apply as noted in the offer above.

If you have commercial insurance (government plans like Medicare or Medicaid are not eligible) and GEMTESA is not covered by your plan, you may pay as little as $95* for a 30-day supply.

• You have commercial insurance (government plans like Medicare or Medicaid are not eligible)

• GEMTESA is covered by your plan

for a

90-daysupply if

*


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



To learn more about your eligibility:



OR

OR


16

IMPORTANT PRODUCT INFORMATIONWhat is GEMTESA?GEMTESA is a prescription medication for the treatment of overactive bladder (OAB) in adults with symptoms of leakage episodes, urgency and frequency.


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).


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.


Please see enclosed Summary of Information about GEMTESA.

PROGRAM TERMS, CONDITIONS, AND ELIGIBILITY CRITERIA

1. This offer is valid only for eligible patients and is good for use only with a valid prescription for GEMTESA at the time the prescription is fi lled by the pharmacist and dispensed to the patient.

2. Depending on your insurance coverage, most commercial patients for whom GEMTESA is covered pay as little as $10 for a 30-day supply or could pay as little as $0 for a 90-day supply between October 1, 2021 and December 31, 2022. Most commercial patients for whom GEMTESA is not covered pay as little as $95 for a 30-day supply. Maximum savings limits apply; patient out-of-pocket expense will vary.

3. This card is valid for up to 12 prescription fi lls for a 30-day supply and 4 prescription fi lls for a 90-day supply.

4. This card expires one-year from activation date.

5. This offer is not valid for use by patients enrolled in Medicare, Medicaid, or other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO Insurance plans that reimburse the patient for the entire cost of the prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefi t program for retirees. This offer is not valid for cash-paying patients.

6. Urovant Sciences reserves the right to rescind, revoke, or amend this offer without notice.

7. Offer good only in the USA, including Puerto Rico, at participating retail pharmacies.

8. Void where prohibited by law, taxed, or restricted.

9. This card is not transferable. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law.

10. This card has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specifi ed prescription.

11. This offer is not health insurance.

12. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.

For questions about this program, please call 1-833-UROVANT (876-8268).

PERSONALNOTES

18

What is GEMTESA?








OR


OR





DISCOVER GEMTESA




LESSTIMETHERE

MORETIMEHERE

LIVINGWITH

OVERACTIVEBLADDER

(OAB)?

What is GEMTESA?








OR


OR





DISCOVER GEMTESA




LESSTIMETHERE

MORETIMEHERE

LIVINGWITH

OVERACTIVEBLADDER

(OAB)?

IMPORTANT INFORMATIONThis 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 oftenIt 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

(gem-tes-ah)

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.

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

©2021 Urovant Sciences. US-VBGN-2000131 04/21

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

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