Gemtesa (vibegron)

Gemtesa may cause serious side effects, including:

• inability to empty your bladder (urinary retention). Gemtesa may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of Gemtesa include:

• urinary tract infection
• nasal congestion, sore throat or runny nose
• nausea
• headache
• upper respiratory tract infection
• diarrhea

These are not all the possible side effects of Gemtesa. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosage

• The 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.

• Concomitant use of Gemtesa increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve (AUC).
• Serum digoxin concentrations should be monitored before initiating and during therapy with Gemtesa and used for titration of the digoxin dose to obtain the desired clinical effect.
• Continue monitoring digoxin concentrations upon discontinuation of Gemtesa and adjust digoxin dose as needed.

• There are no available data on Gemtesa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no data on the presence of vibegron in human milk, the effects of the drug on the breastfed infant, or the effects on milk production.