Gemtesa

The active ingredient in Gemtesa is vibegron. Vibegron is a beta-3 adrenergic receptor agonist that relaxes the bladder muscles so that the bladder can hold a greater volume of fluid. This mechanism of action decreases urgency episodes and improves other OAB symptoms. Unlike other OAB treatment options, it is not an anticholinergic so users will not experience many of the common side effects seen with these other treatments.

In addition to the bladder, these receptors are also found in our blood vessels. Activation of these receptors can increase blood pressure. However, clinical studies looking at the effects of Gemtesa on blood pressure did not find a meaningful change.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Gemtesa. However, the following is a synopsis of the general guidelines for the use of Gemtesa:

• Typically, Gemtesa is taken by mouth once daily with or without food. Take the tablets whole with a full glass of water.
• Use exactly as prescribed. Do not exceed the recommended dose or duration of use.
• If you have trouble swallowing, you can crush the Gemtesa tablet and sprinkle it on a tablespoon of applesauce. Follow with water if some of the medication remains in your mouth.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Gemtesa seen in clinical trials as compared to placebo include:

• Headache
• Urinary tract infection (UTI)
• Diarrhea
• Nausea
• Symptoms of nasopharyngitis (common cold) and other upper respiratory tract infections such as congestion, sore throat, or runny nose
• Dry mouth
• Constipation

Some individuals may experience serious side effects while using Gemtesa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Urinary retention - tell your healthcare provider if you have problems emptying your bladder
• Signs of an allergic reaction such as difficulty breathing and swelling of the tongue, throat, face, lips, or eyes

These are not all of the possible side effects of Gemtesa. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Gemtesa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver problems
• Kidney problems
• Weak urine system or problems with bladder emptying
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Do not use Gemtesa if you have:

• An allergy to vibegron or any of the other ingredients found in Gemtesa

Gemtesa can start working in as little as 2 weeks. However, it may take around 3 months for you to get the full effects of this medication.

When Gemtesa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Digoxin

Gemtesa is available in the following strengths:

• 75 mg tablet

Gemtesa should be stored at room temperature away from light and out of reach of children.

Gemtesa is manufactured by the pharmaceutical company Urovant Sciences.

There is currently no generic version of the brand name Gemtesa. There is a Simple Savings Program from the manufacturer that offers financial support to help cover a portion of the cost. For further information, visit gemtesa.com.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Gemtesa.

It is unknown if Gemtesa can cause harm to the unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Gemtesa can pass into the breastmilk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.