In order to treat the symptoms of conditions of an overactive urinary bladder, GEMTESA is a prescription medicine for adults. Yet GEMTESA side effects can cause many severe problems, find out about them below.
Table of Contents
The symptoms:
- Accidental wetting – characterized by strong urgency to urinate with incidents of wetting or leaking
- Urgency: feeling to urinate immediately
- Frequency: frequently going to the washroom
It is not known if GEMTESA is safe and effective in children.
Common GEMTESA side effects
- Urinary tract infection
- Nasal congestion, sore throat, or runny nose
- Nausea
- Headache
- Upper respiratory tract infection
- Diarrhea
Chemical formulation:
The drug GEMTESA or 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-6carboxamide having a molecular formula of C26H28N4O3 . The molecular weight of GEMTESA is 444.538 g/mol.
It is a white to off-white powder which is mostly crystalline.
Ingredients:
The tablet is made of 75 mg of vibegron as well as several inactive ingredients that follow:
- croscarmellose sodium
- hydroxypropyl cellulose
- magnesium stearate
- mannitol
- microcrystalline cellulose.
The light green film coating contains:
- FD&C Blue No. 2 -aluminum lake
- Hypromellose
- iron oxide yellow
- lactose monohydrate
- titanium dioxide
- triacetin.
Indication:
GEMTESA is indicated to treat bladder (OAB), urinary incontinence, urgency, and urinary frequency in adults.
How to administer the drug?
You need to crush and mix the powder of GEMTESA tablets with a spoon with applesauce, and it should be taken immediately with water.
Prescribed Dosage-
The tablet should be administered in the dosage of 75 mg orally, one tablet once per day before or after eating.
Storage-
GEMTESA 75 mg tablets are light green, oval, film-coated tablets, debossed with V75 on one side and no debossing on the other side.
Package:
It is packaged in two types of 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
These tablets need to be stored at a temperature at 20°C to 25°C (68°F to 77°F)
Note: These tablets should be kept out of sight and reach the children.
Unused medicines can be disposed of following FDA instructions, or you can use a take-back option.
The Possible GEMTESA side effects:
Under different conditions, when GEMTESA was administered, few adverse reactions were observed, but they may not reflect normal practice.
12-week evaluation method
Using different methods, GEMTESA side effects were evaluated in 12 weeks with various patients.
- Few GEMTESA side effects shown in many patients are:
- Disorders such as dry mouth, constipation
- It was observed that residual urine volume increased
- Urinary retention was also seen
- A hot flush was also observed
52 -week evaluation method
GEMTESA was also tested for 52 weeks to observe the drug’s long-term effect.
After the tests and marketing of the drug, the following GEMTESA side effects were observed:
- Urinary retention
- Skin disorders like pruritus, rash, drug eruption, eczema,
- Constipation
Effect of GEMTESA on Lactation-
- When tested, there were no traces of vibegron in human milk, and there was no effect of drugs seen on the breastfed infant or production of milk. But when a dose of radiolabelled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk, which means there are chances that the drug will be present in human milk.
The GEMTESA side effects in children are not proven yet.
Effect of the drug on the Aged-
- The patients who were 75 or older showed no differences in safety or effectiveness of the GEMTESA when the drug was administered for the treatment of patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Renal Impairment-
- The people who have mild to severe renal impairment should not be administered with any amount of dosage adjustment for GEMTESA
Hepatic Impairment-
The patients suffering from liver or hepatic impairment should not be administered this drug in any measure.
GEMSTESA Interactions with other drugs
Associated use of GEMTESA will prompt the increase of maximal digoxin concentrations (Cmax). We need to monitor the Serum digoxin concentrations before introducing the therapy with GEMTESA to obtain clinical effects.
Urinary retention
Usage of GEMTESA has been shown to affect Urinary retention in patients who already have bladder outlet obstruction. In case GEMTESA side effects (urinary retention) develop, GEMTESA should be discontinued.
As there is a risk of urinary retention, the patients who are taking GEMTESA should be informed about it, especially patients who are taking muscarinic antagonist medications for OAB. If patients are continuously experiencing Urinary retention, they should contact their healthcare provider.
These tablets should be swallowed whole with a glass of water or crushed with a spoon and mixed with a tablespoon of applesauce and with a glass of water.
Nonclinical Toxicology
Carcinogenesis
No carcinogenicity was observed on testing the drug with mice after administering the pill for 2 years.
Mutagenesis
It was not observed when Vibegron was administered in the lab microbial reverse mutation assays and didn’t show any evidence of genotoxic activity. Mutagenesis was not observed in even the in vitro. It was also found that the frequency of micro-nucleated polychromatic erythrocytes in an in vivo rat bone marrow micronucleus assay had not increased.
Fertility impairment
In the study done with estimated systemic exposure, the fertility was observed to decrease if the dosage was more than the recommended one was administered.
Pregnancy risk
- There is no evidence to evaluate GEMTESA side effects on pregnant women, including congenital disabilities, miscarriage, or adverse maternal or fetal outcomes.
- In tests on animals, no effects were observed on embryofoetal development following administration of vibegron at the recommended daily dose of GEMTESA in rats and rabbits, respectively. One of the GEMTESA side effects seen were: there was a delay seen in the fatal skeletal ossification in rabbits after the clinical exposure to investigate maternal toxicity.
- The developmental toxicity was observed in offspring in lieu of the treatment during pregnancy and lactation.
- There is only 2 to 4 percent of clinically recognized miscarriages noted. There is some percentage of risk of congenital disability and other adverse outcomes seen.
Overdosage & Contraindications
In case of overdosage of GEMTESA, the treatment should be symptomatic and supportive. Contraindications are seen in patients who have hypersensitivity to vibegron or any of the components of the product.
- Blood Pressure: The drug’s effect on blood pressure is not observed, nor is any effect on cardiac function if administered in the normal dosage.
- Absorption: There was no effect seen in pharmacokinetics seen with the drug, even if it is mixed with applesauce or swallowed whole.
Conclusion
GEMTESA, also known as vibegron, is a prescription medicine for adults to treat urinary incontinence and accidental wetting. Though it has few side effects, it’s a widely prescribed medicine to treat urinary abnormalities.
