【包装规格】：75毫克/片 90片/瓶 

【计价单位】：瓶 

【生产厂家】:Urovant Sciences

【商品名】:Gemtesa 

【药品名】:vibegron（维贝格龙）

作用机理
Vibegron是一种选择性的人类β-3肾上腺素能受体激动剂。β-3肾上腺素能受体的激活通过在膀胱充盈期间放松逼尿肌平滑肌来增加膀胱容量。
适应症和用途
GEMTESA是一种β-3肾上腺素能激动剂，适用于成人膀胱过度活动症（OAB）的治疗，其症状包括急迫性尿失禁，尿急和尿频。
剂量和给药
建议剂量为每天一次一次75毫克片剂。
吞咽片剂整个用水。
片剂可能会被压碎并与苹果酱混合。
剂量形式和强度
片：75毫克
禁忌症
如果事先对vibegron或产品的任何成分发生超敏反应，请勿使用。
警告和注意事项
尿tention留：监测尿retention留，尤其是在膀胱出口梗阻的患者以及使用毒蕈碱拮抗剂治疗OAB的患者中，尿retention留的风险可能更大。如果出现尿retention留，请停用GEMTESA。
不良反应
GEMTESA报告的最常见不良反应（≥2％）为头痛，尿路感染，鼻咽炎，腹泻，恶心和上呼吸道感染。
要报告可疑的不良反应，请致电1-833-876-8268与Urovant Sciences，Inc.或致电1-800-FDA-1088或FDA与WWWW.FDA.GOV/MEDWATCH联系。
药物相互作用
地高辛：在启动GEMTESA之前测量血清地高辛浓度。监测血清地高辛浓度以滴定地高辛剂量达到所需的临床效果。
在特定人群中的使用
儿科用途：尚未确定儿科患者的安全性和有效性。
有或没有血液透析的终末期肾脏疾病：不推荐。
严重肝功能不全：不推荐。
包装供应/存储和处理方式
GEMTESA 75 mg片剂为浅绿色，椭圆形，薄膜衣片，一侧凹陷有V75，另一侧没有凹陷。
GEMTESA以两种包装配置销售：
装有儿童防漏盖的60 cc HDPE瓶中的三十（30）片
NDC 73336-075-30
Ncc 73336-075-90，装在60 cc HDPE瓶中的九十（90）片带有儿童保护帽
存放在20°C到25°C（68°F到77°F），允许偏移到15°C到30°C（59°F到86°F）[请参阅USP控制的室温]。

请将本品和所有药物放在儿童看不见的地方。

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GEMTESA® safely and effectively. See full prescribing information for GEMTESA.

GEMTESA (vibegron) tablets, for oral use Initial U.S. Approval:  2020

-----------------------------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 (1)

------------------------DOSAGE AND ADMINISTRATION---------------------­

•   The recommended dose is one 75 mg tablet once daily. (2.1)

•   Swallow tablet whole with water. (2.1)

•   Tablet may be crushed and mixed with applesauce. (2.1)

---------------------DOSAGE FORMS AND STRENGTHS--------------------­

Tablets: 75 mg (3)

-------------------------------CONTRAINDICATIONS-----------------------------­

Do not use if prior hypersensitivity reaction to vibegron or any components of the product. (4)

------------------------WARNINGS AND PRECAUTIONS----------------------­

Urinary Retention: Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater. If urinary retention develops, discontinue GEMTESA. (5.1)

-------------------------------ADVERSE REACTIONS-----------------------------­

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Urovant Sciences, Inc., at 1-833-876-8268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

-------------------------------DRUG INTERACTIONS------------------------------

Digoxin: Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. (7)

--------------------------USE IN SPECIFIC POPULATIONS--------------------­

Pediatric use: Safety and effectiveness in pediatric patients have not been established. (8.4)

End-stage Renal Disease with or without Hemodialysis: Not recommended.

(8.6)

Severe Hepatic Impairment: Not recommended. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and

FDA-approved patient labeling.

Revised: 12/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1   INDICATIONS AND USAGE

2   DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

3   DOSAGE FORMS AND STRENGTHS

4   CONTRAINDICATIONS

5   WARNINGS AND PRECAUTIONS

5.1 Urinary Retention

6   ADVERSE REACTIONS

6.1  Clinical Trials Experience

6.2  Postmarketing Experience

7   DRUG INTERACTIONS

8   USE IN SPECIFIC POPULATIONS

8.1  Pregnancy

8.2  Lactation

8.4  Pediatric Use

8.5  Geriatric Use

8.6  Renal Impairment

8.7 Hepatic Impairment

10  OVERDOSAGE

11  DESCRIPTION

12  CLINICAL PHARMACOLOGY

12.1  Mechanism of Action

12.2  Pharmacodynamics

12.3  Pharmacokinetics

13  NONCLINICAL TOXICOLOGY

13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility

14  CLINICAL STUDIES

16  HOW SUPPLIED/STORAGE AND HANDLING

17  PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing information are not listed

1   INDICATIONS AND USAGE

GEMTESA® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

2.1    Recommended Dosage

The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. Swallow GEMTESA tablets whole with a glass of water.

In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water [see Clinical Pharmacology 12.3)].

Tablets: 75 mg, oval, light green, film-coated, debossed with V75 on one side and no debossing on the other side.

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product[see Adverse Reactions (6.2)].

5.1  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 [see Adverse Reactions (6.1)].

The following clinically significant adverse reaction is described elsewhere in the labeling:

•      Urinary retention[see Warnings and Precautions (5.1)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of GEMTESA was evaluated in a 12-week, double-blind, placebo- and active-controlled study (Study 3003) in patients with OAB [see Clinical Studies (14)]. A total of 545 patients received GEMTESA. The majority of the patients were Caucasian (78%) and female (85%) with a mean age of 60 years (range 18 to 93 years).

Adverse reactions that were reported in Study 3003 at an incidence greater than placebo and in ≥2% of patients treated with GEMTESA are listed in Table 1.

Other adverse reactions reported in <2% of patients treated with GEMTESA included:

Gastrointestinal disorders:dry mouth, constipationInvestigations:residual urine volume increasedRenal and urinary disorders:urinary retentionVascular disorders:hot flush

GEMTESA was also evaluated for long-term safety in an extension study (Study 3004) in 505 patients who completed the 12-week study (Study 3003). Of the 273 patients who received GEMTESA 75 mg once daily in the extension study, 181 patients were treated for a total of one year.

Adverse reactions reported in ≥2% of patients treated with GEMTESA 75 mg for up to 52 weeks in the long­ term extension study, and not already listed above, were urinary tract infection (6.6%) and bronchitis (2.9%).

The following adverse reactions have been identified during post-approval use of vibegron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse events have been reported in association with vibegron use in worldwide postmarketing experience:

Urologic disorders:urinary retention

Skin and subcutaneous tissue disorders:pruritus, rash, drug eruption, eczema

Gastrointestinal disorders:constipation

Concomitant use of GEMTESA increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve (AUC) [see Clinical Pharmacology (12.3)].Serum digoxin concentrations should be monitored before initiating and during therapy with GEMTESA and used for titration of the digoxin dose to obtain the desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed.

8.1    Pregnancy

Risk Summary

There are no available data on GEMTESA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no effects on embryofetal development were observed following administration of vibegron during the period of organogenesis at exposures approximately 275-fold and 285-fold greater than clinical exposure at the recommended daily dose of GEMTESA, in rats and rabbits, respectively. Delayed fetal skeletal ossification was observed in rabbits at approximately 898-fold clinical exposure, in the presence of maternal toxicity. In rats treated with vibegron during pregnancy and lactation, no effects on offspring were observed at 89-fold clinical exposure. Developmental toxicity was observed in offspring at approximately 458-fold clinical exposure, in the presence of maternal toxicity. No effects on offspring were observed at 89-fold clinical exposure (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In an embryo-fetal developmental toxicity study, pregnant rats were treated with daily oral doses of 0, 30, 100, 300, or 1000 mg/kg/day vibegron during the period of organogenesis (Days 6 to 20 of gestation). These doses were associated with systemic exposures (AUC) 0-, 9-, 89-, 275-, and 1867-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA. No embryo-fetal developmental toxicity was observed at doses up to 300 mg/kg/day. Treatment with the high dose of 1000 mg/kg/day was discontinued due to maternal toxicity.

In an embryo-fetal developmental toxicity study, pregnant rabbits were treated with daily oral doses of 0, 30, 100, or 300 mg/kg/day vibegron during the period of organogenesis (Days 7 to 20 of gestation). These doses were associated with systemic exposures (AUC) 0-, 86-, 285-, and 898-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA. No embryo-fetal developmental toxicity was observed at doses of vibegron up to 100 mg/kg/day. Maternal toxicity (decreased food consumption), reduced fetal body weight, and an increased incidence of delayed skeletal ossification, were observed at 300 mg/kg/day.

In a pre- and post-natal developmental toxicity study, pregnant or lactating rats were treated with daily oral doses of 0, 30, 100, or 500 mg/kg/day vibegron from day 6 of gestation through day 20 of lactation. These doses were associated with estimated systemic exposures (AUC) 0-, 9-, 89-, and 458-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA. No developmental toxicity was observed in  F1 offspring at doses up to 100 mg/kg/day. Maternal toxicity was observed during lactation (decreased body weight gain) at doses ≥100 mg/kg/day and during gestation (decreased body weight gain and food consumption) at 500 mg/kg/day. Developmental toxicity was observed in F1 offspring (increased stillborn index, lethality, reduced viability and weaning indices, decreased body weight and body weight gains, low physical development differentiation indices, and effects on sensory function and reflexes) at 500 mg/kg/day.

Risk Summary

There are no data on the presence of vibegron in human milk, the effects of the drug on the breastfed infant, or the effects on milk production. When a single oral dose of radiolabeled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk (see Data).When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GEMTESA and any potential adverse effects on the breastfed infant from GEMTESA or from the underlying maternal condition.

Data

Animal Data

In a lactational transfer study, lactating rats were treated with a single oral dose of 10 mg/kg radiolabeled [3H] vibegron on postpartum day 10. Levels of radioactivity were determined in milk and plasma collected at 1, 4, 12, and 24 after dosing. The Cmax of total radioactivity in milk and plasma were observed at 9 and 2 hours after dosing, respectively, with a maximum milk-to-plasma concentration ratio of 2.2 observed at 12 hours after dosing. Vibegron elimination from milk showed a similar trend as that from plasma. The radioactivity concentration in milk at 24 hours after administration was approximately 25% of the Cmax.

The safety and effectiveness of GEMTESA in pediatric patients have not been established.

Of 526 patients who received GEMTESA in the clinical studies for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency, 242 (46%) were 65 years of age or older, and 75 (14%) were 75 years of age or older [see Clinical Studies (14)]. No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients.

No dosage adjustment for GEMTESA is recommended for patients with mild, moderate, or severe renal impairment (eGFR 15 to <90 mL/min/1.73 m2). GEMTESA has not been studied in patients with eGFR <15 mL/min/1.73 m2 (with or without hemodialysis) and is not recommended in these patients [see Clinical Pharmacology (12.3)].

No dosage adjustment for GEMTESA is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). GEMTESA has not be studied in patients with severe hepatic impairment (Child-Pugh

C) and is not recommended in this patient population[see Clinical Pharmacology (12.3)].

There is no experience with inadvertent GEMTESA overdosage. In case of suspected overdose, treatment should be symptomatic and supportive.

Vibegron is a selective beta-3 adrenergic agonist. The chemical name is (6S)-N-[4-[[(2S,5R)-5-[(R)­ hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6H-pyrrolo[1,2-a]pyrimidine-6­ carboxamide having a molecular formula of C26H28N4O3 and a molecular weight of 444.538 g/mol. The structural formula of vibegron is:

Vibegron is a crystalline, white to off-white to tan powder.

GEMTESA tablets, for oral administration contain 75 mg of vibegron and the following 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.

12.1    Mechanism of Action

Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.

Vibegron’s exposure-response relationship and the time course of pharmacodynamic response are not fully characterized.

Blood Pressure

In a 4-week, randomized, placebo-controlled, ambulatory blood pressure study in OAB patients (n=200), daily treatment with GEMTESA 75 mg was not associated with clinically significant changes in blood pressure. Subjects enrolled in this study had a mean age of 59 years and 75% were female. Thirty-five percent of subjects had pre-existing hypertension at baseline and 29% of all subjects were taking at least 1 concomitant antihypertensive medication.

Cardiac Electrophysiology

GEMTESA does not prolong the QT interval to any clinically relevant extent at a single dose 5.3 times the approved recommended dose.

Mean vibegron Cmax and AUC increased in a greater than dose-proportional manner up to 600 mg (8 times the approved recommended dosage). Steady state concentrations are achieved within 7 days of once daily dosing. The mean accumulation ratio (Rac) was 1.7 for Cmax and 2.4 for AUC0-24hr.

Absorption

Median vibegron Tmax is approximately 1 to 3 hours.

Oral administration of a 75 mg vibegron tablet crushed and mixed with 15 mL of applesauce resulted in no clinically relevant changes in vibegron pharmacokinetics when compared to administration of an intact 75 mg vibegron tablet.

Effect of Food

No clinically significant differences in vibegron pharmacokinetics were observed following administration of a high-fat meal (53% fat, 869 calories [32.1 g protein, 70.2 g carbohydrate, and 51.1 g fat]).

Distribution

The mean apparent volume of distribution is 6304 liters. Human plasma protein binding of vibegron is approximately 50%. The average blood-to-plasma concentration ratio is 0.9.

Elimination

Vibegron has an effective half-life of 30.8 hours across all populations.

Metabolism

Metabolism plays a minor role in the elimination of vibegron. CYP3A4 is the predominant enzyme responsible for in vitro metabolism.

Excretion

Following a radiolabeled dose, approximately 59% of the dose (54% as unchanged) was recovered in feces and 20% (19% as unchanged) in urine.

Specific Populations

No clinically significant differences in the pharmacokinetics of vibegron were observed based on age (18 to 93 years), sex, race/ethnicity (Japanese vs. non-Japanese), mild (eGFR 60 to <90 mL/min/1.73 m2), moderate (eGFR 30 to <60 mL/min/1.73 m2), and severe (eGFR 15 to <30 mL/min/1.73 m2) renal impairment, or moderate (Child-Pugh B) hepatic impairment. The effect of more severe renal impairment (eGFR <15 mL/min/1.73 m2) with or without hemodialysis or severe (Child-Pugh C) hepatic impairment on vibegron pharmacokinetics was not studied.

Drug Interaction Studies

Clinical Studies

Digoxin: Concomitant administration of vibegron increased digoxin Cmax and AUC by 21% and 11%, respectively.

Other Drugs:No clinically significant differences in vibegron pharmacokinetics were observed when used concomitantly with ketoconazole (P-gp and strong CYP3A4 inhibitor), diltiazem (P-gp and moderate CYP3A4 inhibitor), rifampin (strong CYP3A4 inducer), or tolterodine. No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with vibegron: tolterodine, tolterodine 5-hyroxy metabolite, metoprolol, combined oral contraceptive (ethinyl estradiol, levonorgestrel), or warfarin.

In Vitro Studies

Cytochrome P450 (CYP) Enzymes:Vibegron is a CYP3A4 substrate. Vibegron did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4. Vibegron did not induce CYP1A2, CYP2B6, or CYP3A4.

Transporter Systems:Vibegron is a P-gp substrate. Vibegron did not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2K at clinically relevant concentrations.

13.1   Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

No carcinogenicity was observed in long-term studies conducted in mice and rats treated with daily oral doses of vibegron for approximately 2 years. In the mouse carcinogenicity study, CD-1 mice were treated with daily oral doses of vibegron up to 90 mg/kg/day in males and up to 150 mg/kg/day in females, corresponding to estimated systemic exposures (AUC) 21- and 55-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA. In the rat carcinogenicity study, Sprague Dawley rats were treated with daily oral doses of vibegron up to 30 mg/kg/day in males and up to 180 mg/kg/day in females, corresponding to systemic exposures (AUC) 18- and 117-fold higher, respectively, than in humans treated with the recommended daily dose of GEMTESA.

Mutagenesis

Vibegron was not mutagenic in in vitromicrobial reverse mutation assays, showed no evidence of genotoxic activity in an in vitrohuman peripheral blood lymphocyte chromosomal aberration assay, and did not increase the frequency of micronucleated polychromatic erythrocytes in an in vivorat bone marrow micronucleus assay.

Impairment of Fertility

In fertility/general reproductive toxicity studies conducted in rats, females were treated with daily oral doses of 0, 30, 100, 300, or 1000 mg/kg/day vibegron and males were treated with daily oral doses of 0, 10, 30, or 300 mg/kg/day vibegron. No effects on fertility were observed in female or male rats at doses up to 300 mg/kg/day, associated with systemic exposure (AUC) at least 274-fold higher than in humans treated with the recommended daily dose of GEMTESA. General toxicity, decreased fecundity, and decreased fertility were observed in female rats at 1000 mg/kg/day, associated with estimated systemic exposure 1867-fold higher than in humans treated with the recommended daily dose of GEMTESA.

The efficacy of GEMTESA was evaluated in a 12-week, double-blind, randomized, placebo-controlled, and active-controlled trial (Study 3003, NCT03492281) in patients with OAB (urge urinary incontinence, urgency, and urinary frequency). Patients were randomized 5:5:4 to receive either GEMTESA 75 mg, placebo, or active control orally, once daily for 12 weeks. For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 urge urinary incontinence (UUI) per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. Urge urinary incontinence was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately. The study population included OAB medication-naïve patients as well as patients who had received prior therapy with OAB medications.

The co-primary endpoints were change from baseline in average daily number of micturitions and average daily number of UUI episodes at week 12. Additional endpoints included change from baseline in average daily number of “need to urinate immediately” (urgency) episodes and average volume voided per micturition.

A total of 1,515 patients received at least one daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.

Table 2 shows changes from baseline at week 12 for average daily number of micturitions, average daily number of UUI episodes, average daily number of “need to urinate immediately” (urgency) episodes, and average volume voided per micturition.

Figures 1 and 2 show the mean change from baseline over time in average daily number of micturitions and mean change from baseline over time in average daily number of UUI episodes, respectively.

0.00

Treatment                Placebo (N=520)

GEMTESA 75 mg (N=526)

-0.25

-0.75

-1.00

-1.25

-1.50

-1.75

-2.00

-2.25

Baseline                  2                      4                                               8                                              12

Week

0.00

Treatment                 Placebo (N=405)

GEMTESA 75 mg (N=403)

-0.25

-0.75

-1.00

-1.25

-1.50

-1.75

-2.00

-2.25

Baseline                  2                       4                                                8                                               12

Week

GEMTESA 75 mg tablets are, light green, oval, film-coated tablets, debossed with V75 on one side and no debossing on the other side.

GEMTESA is marketed in two packaging configurations:

Thirty (30) tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-30 Ninety (90) tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-90

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep this and all medications out of sight and reach of children.

Dispose unused medication via a take-back option if available; otherwise follow FDA instructions for disposal in the household trash. See www.fda.gov/drugdisposal for more information.

Advise the patient to read the FDA-approved patient labeling (Patient Information). Urinary Retention

Inform patients that GEMTESA has been associated with urinary retention. Inform patients that the risk of

urinary retention may be increased in patients taking muscarinic antagonist medications for the treatment of OAB. Instruct patients to contact their healthcare provider if they experience symptoms consistent with urinary retention while taking GEMTESA [see Warnings and Precautions (5.1)].

Administration Instructions

Advise patients that GEMTESA tablets can be swallowed whole with a glass of water or may be crushed, mixed with a tablespoon of applesauce and taken immediately with a glass of water [see Dosage and Administration (2.1)].

Manufactured for and Distributed by:

Irvine, CA 92617

GEMTESA® is a trademark of Urovant Sciences GmbH, registered in the U.S. and other countries. All other trademarks are the property of their respective owners.

Patented: see https://www.urovant.com/about/product-patents

© 2020 Urovant Sciences GmbH. All rights reserved.