Gemtesa (vibegron)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Vibegron, a selective beta-3 adrenergic agonist, is a relaxant of the detrusor smooth muscle.
Vibegron, a selective human beta-3 adrenergic receptor agonist, increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.
After oral administration, maximum plasma concentrations are achieved in approximately 1-3 hours, with steady-state concentrations achieved within 7 days of once daily dosing. No significant impact on vibegron pharmacokinetics was observed following administration with a high-fat meal. Vibegron is approximately 50% protein-bound.
The half-life of vibegron is 30.8 hours. Metabolism plays a minor role in the elimination of vibegron; in vitro, vibegron is primarily metabolized by CYP3A4. Following a radiolabeled dose, approximately 59% of the dose was recovered in feces (with 54% recovered as unchanged drug), and 20% was recovered in urine (19% as unchanged drug).
USES: This medication is used to treat overactive bladder. Overactive bladder is a problem with how your bladder stores urine that causes a sudden urge to urinate. The urge may be hard to control, and overactive bladder symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence).
Vibegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of overactive bladder.
Generic name: vibegron
Pronunciation: (vye-BEG-ron)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Gemtesa
Indications
The following indications are listed for Gemtesa:
- Bladder Hyperactivity
- Increased Urinary Frequency
- Urinary Urge Incontinence
- Urinary Urgency
Also known as: Detrusor Overactivity, Hypertonic Bladder, Hypertonicity Of Bladder, Low Compliance Of Bladder, Overactive Detrusor, Urge Incontinence, Urge Urinary Incontinence, Urinary Frequency.
Dosing
No dosing information is available for this tab.
Vibegron is administered orally once daily as a film-coated tablet without regard to meals.
Swallow tablets whole with a glass of water. Alternatively, tablets may be crushed, mixed with approximately 15 mL of applesauce, and taken immediately with a glass of water.
Store tablets at 20-25degreesC (excursions permitted between 15-30degreesC).
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Vibegron is a cytochrome P450 (CYP) 3A4 substrate. Vibegron does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4. Vibegron does not induce CYP1A2, CYP2B6, or CYP3A4.
Vibegron is a P-glycoprotein (P-gp) substrate. Vibegron does not inhibit P-gp, breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1, OATP1B3, organic anion transporter (OAT) 1, OAT3, organic cation transporter (OCT) 1, OCT2, multidrug and toxin extrusion protein (MATE) 1, or MATE2K.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to vibegron or to any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects that occurred in >=2% of patients receiving vibegron include headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
The safety and efficacy of vibegron in pediatric patients have not been established.
There are no available data on vibegron use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In rat and rabbit studies, no effects on embryofetal development were observed following administration of vibegron during organogenesis at exposures approximately 275- and 285-fold greater than clinical exposure at the recommended daily dose of vibegron. Maternal toxicity and delayed fetal skeletal ossification were observed in rabbits at approximately 898-fold clinical exposure. In pregnant and lactating rats treated with vibegron, no effects on offspring were observed at 89-fold clinical exposure; however, at 458-fold clinical exposure, maternal and developmental toxicity were observed.
There are no data on the presence of vibegron in human milk, the effects of vibegron on the breast-fed infant, or the effects of vibegron on milk production. When a single oral dose of radiolabeled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for vibegron and any potential adverse effects on the breast-fed infant from vibegron or from the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Of 526 patients who received vibegron in the clinical studies for OAB, 242 (46%) were >=65 years of age, and 75 (14%) were >=75 years of age. No overall differences in safety or effectiveness of vibegron have been observed between patients >=65 years of age and younger adult patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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