Gemtesa Side Effects in the Elderly: Guide

Managing Mild Incontinence in Older Adults

Common side effects for the elderly for patients who are on Gemtesa (vibegron) include urinary retention, diarrhea, nausea, constipation, headache, and nasopharyngitis (upper respiratory tract infection). However, based on clinical trials, elderly patients 65 and older have not experienced side effects at a greater rate than younger adults.

Key Takeaways

Of the Gemtesa (vibegron) clinical trial, 46% of the 526 patients in the trial were of the age 65 and older. And each of these patients experienced more urinary incontinence, urgency, and frequency as part of the common side effects.
Urinary incontinence is not a major medical issue, however, it can cause a patient not to want to leave their home or perform regular daily tasks due to the fear of losing bladder control.
Other common side effects include dry mouth, diarrhea, and constipation. However, these side effects didn’t show any increased chances of impacting the elderly patients in the trial above young adults.

Gemtesa Side Effects in the Elderly (65 and Older)

According to the Gemtesa (vibegron) clinical trial, “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. No overall differences in safety or effectiveness of Gemtesa have been observed between patients 65 years of age and older and younger adult patients.”

What we can take away from this is that patients 65 years or older may be more prone to experiencing urinary incontinence, urgency, and frequency as the only primary side effect that’s more consistent than others.

Urinary Incontinence in the Elderly

Urinary incontinence (UI) is the unintentional loss of a patient's bladder control. Or the inability to control normal urination. It can range from a minor issue to a major problem that affects daily life. Urinary incontinence (UI) can occur at any age, but it's more common in women over 50 and affects twice as many women as men.

Urinary incontinence (UI) is experienced more in elderly patients than young adults on Gemtesa (vebregon). Urinary incontinence can be somewhat detrimental to the elderly, significantly impacting their quality of life by causing embarrassment, social isolation, or reduced independence. It may also cause an increased risk of falls due to rushing to the bathroom.

Urinary Frequency in the Elderly

While urinary frequency is not a major issue for those 65 and older, it may cause general discomfort, as well. Urinary frequency may cause a patient to want to stay home more or generally feel like they are unable to perform regular daily chores or life needs.

Generally, urinary frequency as a side effect of Gemtesa (vibegron) for the elderly may cause more annoyance than it would cause major health condition issues.

Other Common Side Effects

Since the only exception of side effects that specifically target patients on Gemtesa (vibegron) 65 years or older is urinary urgency incontinence, urgency, and frequency, we should consider the other side effects that will be felt by all patients regardless of age.

These other common side effects include:

Headache: Reported in 4.0% of patients taking Gemtesa, compared to 2.0% with placebo.
Xerostomia (dry mouth): Reported in 1.9% of patients, compared to 1.0% with placebo.
Diarrhea: Reported in 1.7% of patients, compared to 1.4% with placebo.
Nausea: Reported in 1.0% of patients, compared to 0.6% with placebo.
Urinary retention: Reported in 0.6% of patients, compared to 0.6% with placebo (no difference with placebo).
Constipation: Reported in 1.0% of patients, compared to 0.6% with placebo.
Upper respiratory tract infection (nasopharyngitis): Reported in 3.0% of patients, compared to 2.4% with placebo.
Hot flashes: Rare, exact incidence is not typically reported, but this is considered an uncommon side effect.
Fever: Fever is not commonly reported as a side effect in clinical trials for Gemtesa.

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Sources

U.S. Food and Drug Administration. (n.d.). Drug trials snapshot: Gemtesa. Retrieved November 15, 2024, from https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-gemtesa
Urovant Sciences. (2020). Gemtesa prescribing information. Retrieved November 15, 2024, from https://www.gemtesa.com/files/gemtesa-prescribing-information.pdf
The Medical Letter. (2023). Vibegron (Gemtesa) for overactive bladder. The Medical Letter on Drugs and Therapeutics, 62(1623). Retrieved November 12, 2024, from https://secure.medicalletter.org/system/files/private/TML-article-1623c.pdf
U.S. Food and Drug Administration. (2020). Original NDA approval for Gemtesa (NDA 213006). Retrieved November 15, 2024, from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213006Orig1s000Approv.pdf
Sumitomo Pharma. (2023). Notice regarding approval of vibegron (generic name) in China for overactive bladder treatment. Retrieved November 13, 2024, from https://www.sumitomo-pharma.com/news/assets/pdf/ene20230912.pdf