Gemtesa
(Vibegron)Dosage & Administration
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Gemtesa Prescribing Information
Indications and Usage, Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). | 12/2024 |
Contraindications (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 and Adverse Reactions ] .Do not use if prior hypersensitivity reaction to vibegron or any components of the product. | 10/2024 |
Warnings and Precautions, Angioedema (Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any component of GEMTESA [see Contraindications and Adverse Reactions ] . | 10/2024 |
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. ()
1.1 Overactive Bladder in AdultsGEMTESA®is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
- overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). ()
1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH)GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).
- The recommended dose is one 75 mg tablet orally once daily. ()
2.1 Recommended DosageThe 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 ]. - Swallow tablet whole with water. ()
2.1 Recommended DosageThe 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 ]. - Tablet may be crushed and mixed with applesauce. ()
2.1 Recommended DosageThe 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 ].
Tablets: 75 mg, oval, light green, film-coated, debossed with V75 on one side and no debossing on the other side.
The safety and effectiveness of GEMTESA in pediatric patients have not been established.
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
No dosage adjustment for GEMTESA is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). GEMTESA has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in this patient population
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: