Brand Name
Gemtesa
Generic Name
Vibegron
View Brand Information FDA approval date: December 29, 2020
Classification: beta3-Adrenergic Agonist
Form: Tablet
What is Gemtesa (Vibegron)?
GEMTESA ® is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
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Brand Information
GEMTESA (vibegron)
1DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, oval, light green, film-coated, debossed with V75 on one side and no debossing on the other side.
2CONTRAINDICATIONS
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred [see Warnings and Precautions (.
3ADVERSE REACTIONS
The following clinically significant adverse reaction is described elsewhere in the labeling:
- Urinary retention
3.1Clinical 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.
3.2Postmarketing 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 retention
Skin and subcutaneous tissue disorders: angioedema of the face and larynx; hypersensitivity reactions, including urticaria, pruritus, rash and drug eruption; eczema
Gastrointestinal disorders: constipation
4DRUG INTERACTIONS
Concomitant use of GEMTESA increases digoxin maximal concentrations (C
5OVERDOSAGE
There is no experience with inadvertent GEMTESA overdosage. In case of suspected overdose, treatment should be symptomatic and supportive.
6DESCRIPTION
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 C
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.
7HOW 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 HDPE bottle with a child-resistant cap, NDC 73336-075-30
Ninety (90) tablets in a 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.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
9PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label
30 tablets
NDC 73336-075-30
Rx Only
GEMTESA
75 mg
One Tablet • Once Daily
