NDC 73336-075 Gemtesa

Vibegron

NDC Product Code 73336-075

NDC CODE: 73336-075

Proprietary Name: Gemtesa What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Vibegron What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
V75
Score: 1

NDC Code Structure

NDC 73336-075-07

Package Description: 1 BOTTLE in 1 CARTON > 7 TABLET, FILM COATED in 1 BOTTLE

NDC 73336-075-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 73336-075-90

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Gemtesa with NDC 73336-075 is a a human prescription drug product labeled by Urovant Sciences, Inc.. The generic name of Gemtesa is vibegron. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Urovant Sciences, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gemtesa Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • VIBEGRON 75 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Urovant Sciences, Inc.
Labeler Code: 73336
FDA Application Number: NDA213006 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-29-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gemtesa Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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)].

3 Dosage Forms And Strengths

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

4 Contraindications

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)].

6 Adverse Reactions

  • The following clinically significant adverse reaction is described elsewhere in the labeling:Urinary retention [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

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.Table 1: Adverse Reactions, Exceeding Placebo Rate, Reported in ≥2% of Patients Treated with GEMTESA 75 mg for up to 12 Weeks in Study 3003GEMTESA 75 mg n (%)Placebo n (%)Number of Patients545540Headache22 (4.0)13 (2.4)Nasopharyngitis15 (2.8)9 (1.7)Diarrhea12 (2.2)6 (1.1)Nausea12 (2.2)6 (1.1)Upper respiratory tract infection11 (2.0)4 (0.7)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 flushGEMTESA 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%).

6.2 Postmarketing Experience

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 retentionSkin and subcutaneous tissue disorders: pruritus, rash, drug eruption, eczemaGastrointestinal disorders: constipation

7 Drug Interactions

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.

Other

Risk SummaryThere 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 DataIn 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 SummaryThere 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 DataIn 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.

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

AbsorptionMedian 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 FoodNo 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]).

DistributionThe 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.

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

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

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

Specific PopulationsNo 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.

CarcinogenesisNo 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.

MutagenesisVibegron was not mutagenic in in vitro microbial reverse mutation assays, showed no evidence of genotoxic activity in an in vitro human peripheral blood lymphocyte chromosomal aberration assay, and did not increase the frequency of micronucleated polychromatic erythrocytes in an in vivo rat bone marrow micronucleus assay.

Impairment of FertilityIn 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.

Urinary RetentionInform 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 InstructionsAdvise 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:Urovant Sciences, Inc.Irvine, CA 92617GEMTESA® 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.

8.4 Pediatric Use

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

8.5 Geriatric Use

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.

8.6 Renal Impairment

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)].

8.7 Hepatic Impairment

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)].

10 Overdosage

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

11 Description

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.

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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.

14 Clinical Studies

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.Table 2: Mean Baseline and Change from Baseline at Week 12 for Micturition Frequency, Urge Urinary Incontinence Episodes, "Need to Urinate Immediately" (Urgency) Episodes, and Volume Voided per MicturitionParameterGEMTESA 75 mgPlaceboAverage Daily Number of MicturitionsBaseline mean (n)11.3 (526)11.8 (520)Change from BaselineLeast squares mean adjusted for treatment, baseline, sex, geographical region, study visit, and study visit by treatment interaction term. (n)-1.8 (492)-1.3 (475)Difference from Placebo-0.595% Confidence Interval-0.8, -0.2p-value<0.001Average Daily Number of UUI EpisodesBaseline mean (n)3.4 (403)3.5 (405)Change from Baseline (n)-2.0 (383)-1.4 (372)Difference from Placebo-0.695% Confidence Interval-0.9, -0.3p-value<0.0001Average Daily Number of "Need to Urinate Immediately" (Urgency) EpisodesBaseline mean (n)8.1 (526)8.1 (520)Change from Baseline (n)-2.7 (492)-2.0 (475)Difference from Placebo-0.795% Confidence Interval-1.1, -0.2p-value0.002Average Volume Voided (mL) per MicturitionBaseline mean (n)155 (524)148 (514)Change from Baseline (n)23 (490)2 (478)Difference from Placebo2195% Confidence Interval14, 28p-value<0.0001Figures 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.Figure 1: Mean (SE) Change from Baseline in the Average Daily Number of MicturitionsFigure 2: Mean (SE) Change from Baseline in the Average Daily Number of UUI Episodes in Patients with At Least 1 Average Daily UUI Episode at Baseline

16 How Supplied/Storage And Handling

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

Storage And Handling

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.

17 Patient Counseling Information

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

Spl Patient Package Insert

  • PATIENT INFORMATIONGEMTESA [gem tes' ah] (vibegron)tablets, for oral useThis Patient Information has been approved by the U.S. Food and Drug Administration.Approved: 12/2020What 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 accidentsurgency: the need to urinate right awayfrequency: urinating oftenIt is not known if GEMTESA is safe and effective in children.Do not take GEMTESA if you:are allergic to vibegron or any of the ingredients in GEMTESA. See the end of this leaflet for a complete list of ingredients in 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. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.How should I take GEMTESA?Take GEMTESA exactly as your doctor tells you to take it.Take 1 GEMTESA tablet, by mouth, 1 time a day with or without food.Swallow GEMTESA tablets whole with a glass of water.You may also crush GEMTESA tablets, mix with 1 tablespoon (about 15 mL) of applesauce, and take right away with a glass of water.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.The most common side effects of GEMTESA include:urinary tract infectionheadachenasal congestion, sore throat or runny nosediarrheanauseaupper respiratory tract infectionThese 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.How should I store GEMTESA?Store GEMTESA at room temperature between 68°F to 77°F (20°C to 25°C).Safely throw away medicine that is no longer needed in your household trash.You may also dispose of the unused medicine through a take-back option, if available. See www.fda.gov/drugdisposal for more information.Keep GEMTESA and all medicines out of the reach of children.General information about the safe and effective use of GEMTESA.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GEMTESA for a condition for which it was not prescribed. Do not give GEMTESA to other people, even if they have the same symptoms that you have. It may harm them.You can ask your doctor or pharmacist for information about GEMTESA that is written for health professionals.What are the ingredients in GEMTESA?Active ingredient: vibegronInactive 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.Manufactured for and Distributed by:Urovant Sciences, Inc.Irvine, CA 92617GEMTESA® 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.For more information, go to www.GEMTESA.com or call 1-833-876-8268.

* Please review the disclaimer below.